[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumor-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumor-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,37,0,25,[9,42,74,109,176,205,228,248,283,311,334,357,389,416,440,469,499,523,542,570,592,613,632,656,678],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100644495","phase-2-metronomic-gemcitabine-mitomycin-c-and-thalidomide-for-advanced-solid-tumors-100644495",false,"NCT07671534","Metronomic Gemcitabine, Mitomycin C, and Thalidomide for Advanced Solid Tumors","GEMINI: Phase II Study Using Metronomic Gemcitabine, Mitomycin C, and Thalidomide for Advanced Solid Tumors","GEMINI","Inclusion Criteria:\n\n1. Male or Female ≥ 18 years of age\n2. Pathologically confirmed diagnosis of locally advanced or metastatic solid tumor\n3. Previously treated participants\n4. Measurable disease by RECIST v1.1\n5. ECOG performance status ≤ 1\n6. Life expectancy of at least 3 months\n7. Acceptable liver function: Bilirubin ≤ 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level \\\u003C 3.0 ULN); AST (SGOT), ALT (SGPT) and alkaline phosphatase ≤ 3 x ULN (\\\u003C 5 x ULN if liver metastases); Acceptable renal function: Creatinine \\\u003C 1.5 times ULN\n8. Acceptable hematologic status (without hematologic support e.g. growth factors or transfusion within 21 days of first dose of study agents): ANC ≥ 1500 cells\u002FμL; Platelet count ≥ 100,000\u002FμL; Hemoglobin ≥ 9.0 g\u002FdL; Normal PT, PTT, INR\n9. All women of childbearing potential must have a negative pregnancy test and all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.\n10. Females of reproductive potential must have 2 negative pregnancy tests before initiating THALOMID. The first test should be performed within 10-14 days, and the second test within 24 hours prior to prescribing THALOMID. Once treatment has started and during dose interruptions, pregnancy testing for females of reproductive potential should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated every 4 weeks in females with regular menstrual cycles. If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in her menstrual bleeding. THALOMIDE treatment must be discontinued during this evaluation.\n11. Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the principal investigator's IRB\u002FEthics Committee\n12. Willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n1. Subjects with untreated CNS metastases. Subjects are eligible if CNS metastases have been adequately treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to treatment initiation. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of \\\u003C10 mg daily prednisone (or equivalent) for at least 2 weeks prior to treatment initiation.\n2. Subjects with carcinomatous meningitis\n3. Subjects who participated in an investigational drug or device study within 14 days prior to study entry\n4. Subjects who had chemotherapy within 14 days prior to study entry\n5. Females who are pregnant or breast-feeding\n6. Unwillingness or inability to comply with the study protocol for any reason\n7. Evidence of severe or uncontrolled systemic disease or any other concurrent condition, including psychiatric, which in the principal investigator's opinion makes it undesirable for the participant to participate in the trial or which would jeopardize compliance with the trial\n8. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection\n9. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).","ALL","18 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is an open label phase II study using metronomic low-dose gemcitabine and mitomycin c given intravenously, and thalidomide administered orally, for patients with advanced solid tumors.",[28],"Solid Tumor Cancer","RECRUITING","2026-06-22",{"date":32,"type":33},"2026-06-26","ACTUAL",{"date":35,"type":22},"2026-06",{"date":37,"type":22},"2029-06",{"name":39,"class":40},"Sarcoma Oncology Research Center, LLC","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":18,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":61,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":41},"100577736","effect-of-meal-timing-during-cancer-treatment-in-patients-in-alaska-a-randomized-clinical-trial-100577736","NCT06802172","Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Male or female\n* Self-identify as Alaska Native or American Indian person and eligible for care at the ANMC\n* Age≥21 years\n* Histologically confirmed rectal cancer stage II, III, or IV (if curative) per AJCC criteria (neoadjuvant)\n* Histologically confirmed HER2+ or triple negative breast cancer stage I, II, or III, per AJCC criteria (neoadjuvant)\n* Histologically or cytologically confirmed solid tumor (adjuvant)\n* BMI≥18.5 kg\u002Fm2\n* Plan to receive neoadjuvant or adjuvant therapy\n* Planned duration of neoadjuvant or systemic adjuvant therapy for \\>3 months to allow sufficient time to assess impact of intervention\n* Must have capacity to give informed consent\n* Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions\n* Has completed ≤ 4 weeks of neoadjuvant or adjuvant treatment prior to study enrollment\n* Score of \\\u003C 4 on U.S. Household Food Security Survey Module: Six-Item Short Form OR if score \\>5, have clearance from dietitian\n\nExclusion Criteria:\n\n* History of cytotoxic chemotherapy ≤12 months prior to rectal or breast cancer diagnosis (neoadjuvant)\n* Allergic reaction to any of the treatment agents\n* Any prior pelvic radiotherapy\n* Active second malignancy (exceptions: non-melanoma skin cancers or cervical carcinoma in situ adequately treated) requiring systemic therapy\n* History of GI perforation ≤12 months prior to enrollment\n* History of predisposing colonic or small bowel disorders with severe or rapidly worsening symptoms (not related to current cancer symptoms)\n* Receiving any parenteral nutrition or enteral (tube) feeding or using similar nutritional supplement during the study period\n* History of uncontrolled CHF defined as NYHA Class III or greater\n* Pre-existing grade ≥3 neuropathy\n* Currently participating in or has participated in a study of an investigational agent or investigational device ≤4 weeks of the first dose of treatment\n* Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)\n* Pregnant or breastfeeding\n* Currently perform overnight shift work \\>1 day\u002Fweek\n* Strictly adhering to a \\\u003C10-hour eating window on most days\n* Severe psychiatric, cognitive, or substance misuse disorders or social conditions that would interfere with adherence to study procedures.","21 Years",{"count":50,"type":22},100,[52],"NA","The goal of this clinical trial is to test meal-timing as a novel and sustainable interventional approach during cancer treatment to improve therapeutic response and metabolic health in an understudied population. This clinical trial will enroll patients with rectal or breast cancer receiving neoadjuvant treatment at the Alaska Native Medical Center (ANMC), which is part of the Alaska Native Tribal Health Consortium (ANTHC).\n\nA promising strategy for improving the efficacy of anticancer treatments and reducing associated toxicities involves combining treatment with fasting regimens. In pre-clinical and clinical studies, various forms of fasting have been shown to induce tumor regression and improve long-term survival. According to the differential stress sensitization theory, fasting is thought to sensitize tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. While healthy cells slow their growth and become more stress resistant in response to fasting, cancer cells cannot survive in nutrient-deficient environments; although the underlying mechanisms are not fully understood. However, extended water-only fasting can be challenging for patients and poses undue health risks. Intermittent fasting, and specifically time-restricted eating (TRE), may offer a viable alternative. TRE involves eating within a shorter window (e.g., 8 hours) and fasting for the remainder of the day but involves no other dietary restrictions. Because of its simplicity, TRE may be more sustainable than other fasting regimens. TRE also improves several cardio-metabolic endpoints, including insulin sensitivity, which may also be beneficial during anticancer treatments.",[55,56,57,58,59,60,28],"Rectal Cancer Stage II","Rectal Cancer Stage III","Breast Cancer Stage I","Rectal Cancer Stage IV","Breast Cancer Stage II","Breast Cancer Stage III",[62,63,64],"Time-restricted eating","Time restricted eating","Meal timing","2026-06-19",{"date":67,"type":33},"2026-06-24",{"date":69,"type":22},"2026-07-07",{"date":71,"type":22},"2029-08-31",{"name":73,"class":40},"Fred Hutchinson Cancer Center",{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":85,"conditions":86,"keywords":98,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":41},"100644129","phase-1-imaging-study-of-89zrdfo-ys5-for-cancer-detection-100644129","NCT07664397","Imaging Study of [89Zr]DFO-YS5 for Cancer Detection","A Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detection of Cancer in Patients With Various Malignancies","Inclusion Criteria:\n\n1. Histological or cytological confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor neoplasm.\n2. At least one soft tissue lesion measurable at 1 cm or greater in short axis measurement on cross sectional imaging such as Computerized tomography (CT), magnetic resonance imaging (MRI), or Positron Emission Tomography (PET)\u002FCT (scan imaging as documented in the medical record). Exception: For participants with localized bladder cancer (pre-cystectomy), lesions smaller than 1 centimeter (cm) are permitted, provided there is cystoscopic confirmation of a bladder mass.\n3. Clinically able to undergo PET-CT imaging or PET-MRI.\n4. Age ≥ 18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50% (see Appendix 1).\n6. Adequate organ function as defined below:\n\n   * Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits).\n   * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)): ≤ 3 x ULN.\n   * Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)): ≤ 3 x ULN.\n   * Estimated creatinine clearance: ≥ 60 mL\u002Fmin, calculated using the Cockcroft-Gault equation.\n7. Females of reproductive potential (defined below) must be willing to undergo a urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours before administration of \\[89Zr\\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries). The result of the urine or serum pregnancy test must be negative in order to initiate the \\[89Zr\\]DFO-YS5 administration. If a urine pregnancy test is positive or equivocal, a confirmatory a serum pregnancy test is required. The individual must be excluded from participation if the serum pregnancy result is positive. Pregnant individuals are excluded from this study because there is an unknown but potential risk for adverse effects in the unborn child secondary to treatment of the study participant with \\[89Zr\\]DFO-YS5.\n8. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.\n9. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia) or PET-MRI (e.g., implanted devices, metallic objects, or other implants). Participants must be able to undergo either PET-CT or PET-MRI.\n2. Individuals who are pregnant or breastfeeding\u002Fchest-feeding. Pregnant and breastfeeding\u002Fchest-feeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn\u002Fnursing child secondary to treatment of the study participant with \\[89Zr\\]DFO-YS5. Females of childbearing potential must have a negative pregnancy test before administration of \\[89Zr\\]DFO-YS5, as outlined in inclusion criterion #7. Breastfeeding\u002Fchest-feeding should be discontinued before administration of \\[89Zr\\]DFO-YS5.\n3. Individuals who do not agree to follow the below contraception requirements:\n\n   Females of reproductive potential (defined below) must agree to use two forms of contraception, consisting of a barrier method (such as condoms) in combination with a secondary complementary method (such as hormonal, Intrauterine device (IUD), etc.), or strict abstinence, for the duration of study participation and for 1 month after administration of \\[89Zr\\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries).\n4. Hypersensitivity to \\[89Zr\\]DFO-YS5 or any of its excipients.\n5. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.",{"count":82,"type":22},40,[84],"PHASE1","This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\\[89Zr\\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.",[87,88,89,90,28,91,92,93,94,95,96,97],"Bladder Cancer","Nerve Sheath Tumor","Nerve Sheath Tumors","Solid Tumor Malignancies","Solid Tumor Neoplasms","Advanced Solid Tumor","Bladder Neoplasm","Nerve Sheath Neoplasms","Nerve Sheath Tumor, Nos","Solid Tumor, Adult","Solid Carcinoma",[99],"Imaging Study","NOT_YET_RECRUITING","2026-06-17",{"date":67,"type":33},{"date":104,"type":22},"2026-08-01",{"date":106,"type":22},"2029-09-30",{"name":108,"class":40},"Robert Flavell, MD, PhD",{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":18,"minAge":117,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":143,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":41},"100562786","phase-1-study-in-children-and-adolescents-of-177lu-dotatate-lutathera-combined-with-the-parp-inhibitor-olaparib-for-the-treatment-of-recurrent-or-relapsed-solid-tumours-expressing-somatostatin-receptor-sstr-luparped-100562786","NCT06607692","Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","Single-arm Open-label Phase I\u002FII Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","LUPARPED","Inclusion criteria:\n\n* 18 months - 18 years of age at the time of the initial diagnosis.\n* ≥ 3 years at the moment of inclusion in the trial.\n* Diagnosis: relapsed\u002Frefractory solid tumours with positive uptake on SSTR-PET (PET-CT or PET-MRI), performed in the previous three months before entering the study.\n\nThe evaluation of SSTR expression will be classified according to a qualitative 4-point scale: SSTR expression V (visual score):\n\n* Score = 0: Below or equal to blood pool\n* Score = 1: Above blood pool and lower than liver\n* Score = 2: Equal to or above liver and lower than spleen\n* Score = 3: Equal to or above spleen\n\nPatients with scores ≥ 2 in the majority of the tumoral lesions will be considered to have a positive SSTR-PET and will be therefore eligible for the trial. Patients with a higher score are presumed to have a better response to the treatment.\n\nIt is admissible to have non-measurable disease only (e.g., HR-NB with bone-only or bone-marrow-only active disease).\n\n* Performance status ≥ 50% according to Lansky scale (\\\u003C16 years old) or Karnofsky scale (for ≥16 years old).\n* Life expectancy of at least 3 months.\n* Availability of ability to swallow tablets or capsules.\n* Adequate organ function within 28 days prior to enrolment, as defined by:\n\n  * Hb ≥10 g\u002Fdl (packed red blood transfusion is acceptable up to 24 hours prior starting treatment);\n  * White blood cell (WBC) count ≥ 2500\u002FμL (equivalent to 2.5 x 109\u002FL)\n  * Absolute Neutrophil Count (ANC) ≥ 1000\u002Fμl;\n  * Platelets ≥ 100.000\u002Fμl, without transfusion in the prior ≥7 days;\n  * Serum plasma creatinine ≤ 1.5 x upper limit of normal (ULN) OR estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m2 (assessed by 2009-Schwartz formula).\n  * Total bilirubin ≤ 1.5 x the institutional ULN. For patients with known Gilbert's Syndrome ≤ 3.0 ULN is permitted.\n  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 ULN.\n  * Albumin \\>3.0 g\u002FdL (3.0 g\u002FdL is equivalent to 30 g\u002FL)\n* A negative serum or urine pregnancy test in women with onset of menses or ≥12 years of age.\n* Patients of reproductive potential must agree to use highly effective contraceptive methods for the entire study duration and up to 7 months, in case of females, and 4 months in case of males, after the last dose of Lutathera, or up to 6 months, in case of females, and 3 months in case of males, after the last dose of olaparib, whichever takes places later.\n* Have the ability to comprehend and willingness to provide written informed consent (ICF) for the study before patient registration or any trial-related screening procedures. If the patient is \\\u003C18 years old, the written informed consent must be signed by the parent(s) or legal guardian(s) according to national regulations. In the case of patients between 12 and 17 years, they must sign an assent form, and if the patient turns 18 during their participation in the study, they must sign an informed consent form.\n* Adequate recovery from major surgery prior to receiving study treatment.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n\nExclusion criteria\n\n* Previous significant drug-induced hepatitis toxicity experienced in the past that has required treatment dose reductions, treatment discontinuation or that, at the investigator discretion, could infer a risk.\n* Having received more than one previous treatment with other radiolabelled somatostatin analogues.\n* Inability to swallow tablets or capsules.\n* Subjects who are currently receiving any other anticancer and\u002For investigational agents (e.g. chemotherapy, immunotherapy or biological therapy \\[including monoclonal antibodies\\]). There must be at least 28 days of washout from any prior treatment. In case of checkpoints inhibitors, there should be at least 4 months of washout. Palliative Radiation Therapy for symptom control (e.g. pain relief) could be acceptable, at the discretion of the investigator.\n* Treatment with long-acting somatostatin analogues within 28 days prior the administration of 177Lu-DOTATATE.\n* Known hypersensitivity to any of the excipients.\n* Subjects who have an uncontrolled infection.\n* Lactating women.","3 Years",{"count":7,"type":22},[84,25],"Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)",[28,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142],"Medulloblastoma","High Risk Neuroblastoma","High Grade Gliomas","Meningioma","Paraganglioma","Pheochromocytoma","Neuroendocrine Tumours (NET)","Adrenal Tumours","DIPG","Glioblastoma","Glioblastoma (GBM)","Osteosarcoma Recurrent","Carcinoma Adrenal","Synovial Sarcomas","Esthesioneuroblastoma","Neuroblastoma Recurrent","Solid Tumor Refractory to Conventional Treatment","Medulloblastoma Recurrent","Paraganglioma\u002F Phaeochromocytoma","Ependymoma","Ependymoma Recurrent",[144,145,146,147,148,149,150,151,152,153,154,155,156,130,157,158,159,160,161,162,163,164,165,141,166],"solid tumours","somatostatin receptors","SSTR","LUTETIUM","OLAPARIB","MEDULLOBLASTOMA","NEUROBLASTOMA","HIGH GRADE GLIOMA","MEININGIOMA","PARAGANGLIOMA","PHEOCHROMOCYTOMA","NEUROENDOCRINE TUMOURS","ADRENAL TUMOR","GLIOBLASTOMA","OSTEOSARCOMA","CARCINOMA ADRENAL","SYNOVIAL SARCOMA","ESTHESIONEUROBLASTOMA","RECURRENT","RELAPSED","RELAPSE","REFRACTORY","Ependimoma Recurrent","2026-06-02",{"date":169,"type":33},"2026-06-04",{"date":171,"type":33},"2024-09-20",{"date":173,"type":22},"2029-12",{"name":175,"class":40},"Fundación de investigación HM",{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":23,"phases":185,"briefSummary":186,"conditions":187,"keywords":191,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":204},"100607819","phase-1-beacon-1-study-of-avzo-103-as-a-single-agent-and-in-combination-therapy-in-patients-with-locally-advanced-or-metastatic-urothelial-cancer-or-other-solid-tumors-avzo-103-1001-100607819","NCT07193511","BEACON-1: Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors (AVZO-103-1001)","A Phase 1\u002F2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-103, a Nectin4\u002FTrop2 ADC, as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","Key Inclusion Criteria:\n\n* Patient must be an adult, 18 years of age and older with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \\> 3 months.\n* Patients with histologically or cytologically confirmed locally advanced\u002Fmetastatic malignancies for tumor types of preferred indications:\n\n  o Locally advanced or metastatic urothelial cancer and other solid tumors (as specified in the protocol).\n* Measurable disease as assessed by Investigator using RECIST v1.1.\n* Agree to provide molecular test report results to confirm eligibility and archival tumor samples and\u002For fresh biopsy, as applicable.\n* Other protocol-defined Inclusion criteria apply.\n\nKey Exclusion Criteria:\n\n* Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.\n* Prior Stevens-Johnson syndrome\u002Ftoxic epidermal necrolysis.\n* History of drug-induced interstitial lung disease (ILD).\n* History of any serious cardiovascular condition.\n* Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.\n* History of allogenic stem cell or solid organ transplant.\n* Other protocol-defined Exclusion criteria apply.",{"count":184,"type":22},355,[84,25],"This study, the first clinical trial of AVZO-103, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-103 when administered intravenously as a monotherapy and in combination therapy to patients with locally advanced or metastatic urothelial cancer or other solid tumors.",[28,188,189,190],"Locally Advanced","Metastatic Solid Tumors","Urothelial Cancer",[192,193,188,190],"Solid Tumors","Metastatic","2026-05-21",{"date":196,"type":33},"2026-05-26",{"date":198,"type":33},"2025-10-02",{"date":200,"type":22},"2030-09",{"name":202,"class":203},"Avenzo Therapeutics, Inc.","INDUSTRY",10,{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":4},"100640781","phase-1-a-phase-i-study-of-jl19001-injection-alone-or-in-combination-with-standard-therapy-in-patients-with-advanced-solid-tumors-or-relapsedrefractory-b-cell-non-hodgkin-lymphoma-100640781","NCT07603479","A Phase I Study of JL19001 Injection Alone or in Combination With Standard Therapy in Patients With Advanced Solid Tumors or Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for this study:\n\n1. Age and Gender: Aged ≥ 18 years at the time of signing the Informed Consent Form (ICF), regardless of gender.\n2. Disease Status: Patients with histologically or cytologically confirmed advanced solid tumors (AST) or relapsed\u002Frefractory B-cell non-Hodgkin lymphoma (r\u002Fr B-NHL) who have failed standard therapy, have no available standard treatment options, are intolerant to, or refuse standard therapy. This includes, but is not limited to, melanoma, renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (SCCHN), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone B-cell lymphoma (MZL). Specific requirements for each tumor type are as follows:\n\n   Melanoma: Advanced cutaneous or acral melanoma with progressive disease (PD) after ≥2 prior lines of systemic therapy. Prior treatment must include at least one immune checkpoint inhibitor (ICI; e.g., pembrolizumab, toripalimab, pucotenlimab, ipilimumab + nivolumab, atezolizumab) and at least one chemotherapy (e.g., dacarbazine, temozolomide, paclitaxel, nab-paclitaxel, cisplatin\u002Fcarboplatin, fotemustine). For patients with BRAF V600, NRAS, or KITmutations, prior treatment must include at least one targeted therapy against the specific mutation and one ICI (as listed above). Patients unsuitable for or intolerant to the aforementioned treatments are excluded.\n\n   RCC: Metastatic or unresectable clear cell RCC with PD after ≥1 prior line of therapy or intolerance to ≥1 prior line. Prior treatment must include at least one targeted therapy (e.g., sunitinib, pazopanib, sorafenib, axitinib, lenvatinib, anlotinib, vorolanib + everolimus) and one ICI (e.g., toripalimab, pembrolizumab, benmelstobart, nivolumab, ipilimumab).\n\n   NSCLC: Stage IV NSCLC with PD after ≥2 prior lines of systemic therapy. For patients without driver alterations: Prior treatment must include at least one ICI (e.g., pembrolizumab, camrelizumab, tislelizumab, sintilimab, atezolizumab, sugemalimab, toripalimab, penpulimab, serplulimab, nivolumab + ipilimumab, ivonescimab) and\u002For platinum-based chemotherapy, plus one single-agent therapy (e.g., docetaxel, pemetrexed, gemcitabine, paclitaxel, vinorelbine, anlotinib).\n\n   For patients with driver alterations (e.g., EGFRmutations, ALKfusions, ROS1fusions, BRAF V600mutations, NTRKfusions, METexon 14 skipping, RETalterations, KRAS G12Cmutations, or HER2mutations): Prior treatment must include at least one targeted therapy against the specific alteration and one platinum-doublet chemotherapy or single-agent therapy (as listed above). Patients unsuitable for or intolerant to the aforementioned treatments are excluded.\n\n   SCCHN: Metastatic head and neck squamous cell carcinoma with PD after ≥2 prior lines of systemic therapy.\n\n   Non-nasopharyngeal carcinoma: Prior treatment must include platinum-based chemotherapy and either an ICI (e.g., pembrolizumab, finotonlimab, toripalimab, nivolumab) or an EGFR monoclonal antibody (e.g., cetuximab).\n\n   Nasopharyngeal carcinoma: Prior treatment must include platinum-based chemotherapy and an ICI (e.g., camrelizumab, toripalimab, tislelizumab, penpulimab, tagitanlimab). Patients unsuitable for or intolerant to the aforementioned treatments are excluded.\n\n   r\u002Fr B-NHL: PD after ≥2 prior lines of systemic therapy. Prior treatment must include a regimen containing an approved CD20 antibody (e.g., rituximab, zuberitamab, ripertamab).\n\n   Note: The later-line treatment status for all patients will be determined by the Investigator.\n3. Measurable Disease: Presence of at least one evaluable tumor lesion according to RECIST 1.1 (solid tumors) or Lugano criteria (lymphoma). Note: Lesions previously irradiated are not considered target lesions unless there is documented progression within the irradiated field or persistence of the lesion \\>3 months after radiotherapy.\n4. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (refer to Appendix 1: ECOG Performance Status).\n5. Laboratory Parameters: Adequate organ function within 14 days prior to enrollment, defined as:\n\n   Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL Platelet Count (PLT) ≥ 100 × 10⁹\u002FL Hemoglobin (HGB) ≥ 90 g\u002FL Total Bilirubin ≤ 1.5 × Upper Limit of Normal (ULN) Aspartate Aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases or hepatocellular carcinoma) Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases or hepatocellular carcinoma) Serum Creatinine ≤ 1.5 × ULN, or Calculated Creatinine Clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula) Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN International Normalized Ratio (INR) ≤ 1.5 × ULN\n6. Life Expectancy: Expected survival ≥ 12 weeks.\n7. Contraception and Pregnancy:\n\n   Participants of childbearing potential and their partners must agree to use highly effective non-pharmacological contraceptive methods during the study and for at least 12 weeks after the last dose.\n\n   Female participants of childbearing potential who are not surgically sterile must have a negative serum β-human chorionic gonadotropin (β-HCG) test within 7 days prior to the first dose and must not be breastfeeding.\n8. Consent and Compliance: Ability to understand and voluntarily sign the ICF, and willingness to comply with scheduled visits as per protocol.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be ineligible for this study:\n\n1. Hypersensitivity: Known hypersensitivity to any component of the investigational product or to drugs of the same class.\n2. CNS Metastases:\n\n   Patients with active central nervous system (CNS) metastases and\u002For carcinomatous meningitis are excluded.\n\n   However, the following patients are allowed:\n\n   ① Asymptomatic brain metastasis: No progressive CNS symptoms attributed to brain metastases, not requiring corticosteroids or requiring ≤ 10 mg\u002Fday prednisone (or equivalent), and lesion size ≤ 1.5 cm. These patients require regular brain imaging as a disease assessment site.\n\n   ② Treated brain metastases: Stable brain metastases for at least 2 months (confirmed by two imaging assessments at least 4 weeks apart post-treatment), with no evidence of new or enlarging lesions, and discontinued steroids ≥ 3 days prior to the first dose. Stability must be established prior to the first dose.\n3. Cardiac Conditions: Any of the following cardiac conditions:\n\n   1. QTc interval \\> 450 ms (male) or \\> 470 ms (female).\n   2. New York Heart Association (NYHA) Class III or IV congestive heart failure.\n   3. Unstable angina, new-onset angina, or myocardial infarction within 6 months prior to screening.\n   4. Clinically significant arrhythmias, including but not limited to complete left bundle branch block, second-degree atrioventricular block, or PR interval \\> 250 ms.\n   5. Valvular heart disease ≥ Grade 2 (CTCAE).\n   6. Left ventricular ejection fraction (LVEF) \\\u003C 50% as measured by echocardiogram.\n   7. Uncontrolled hypertension (systolic BP \\> 160 mmHg or diastolic BP \\> 100 mmHg); orthostatic hypotension or drug-induced hypotension (systolic BP \\\u003C 90 mmHg or diastolic BP \\\u003C 60 mmHg).\n   8. Uncontrolled systemic disease despite regular treatment (e.g., diabetes).\n4. Prior Immune Toxicity: History of prior immunotherapy with ≥ Grade 3 immune-related adverse events (irAEs) or ≥ Grade 2 immune-mediated myocarditis.\n5. Coagulopathy: Hereditary bleeding diathesis or coagulopathy, or history of clinically significant bleeding disorders or arterial\u002Fvenous thromboembolism (e.g., cerebrovascular events, deep vein thrombosis, pulmonary embolism) within 6 months prior to the first dose.\n6. Autoimmune Disease: Active autoimmune diseases such as systemic lupus erythematosus, rheumatic diseases, Crohn's disease, ulcerative colitis, etc.\n7. GI Perforation\u002FFistula: History of gastrointestinal perforation\u002Ffistula or risk factors for perforation within 6 months prior to the first dose.\n8. GI Bleeding: Any ≥ Grade 3 gastrointestinal bleeding within 12 weeks prior to the first dose.\n9. Transplantation: Prior allogeneic hematopoietic stem cell transplantation or organ transplantation.\n10. Interstitial Lung Disease: History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, or clinically significant active pneumonitis at screening (excluding radiation-induced fibrosis not requiring steroid treatment).\n11. Effusions: Uncontrollable pleural effusion, pericardial effusion, or ascites, in the judgment of the Investigator.\n12. Other Malignancies: History of any other active malignancy within 3 years prior to the first dose (except for curatively treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or cancers with a disease-free survival \\> 1 year after radical treatment).\n13. Surgery\u002FTrauma: Major surgical procedure (excluding core needle biopsy) or significant traumatic injury within 4 weeks prior to the first dose, or planned elective surgery during the study period.\n14. Prior Anticancer Therapy: Receipt of chemotherapy, radiotherapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy, or investigational agents within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose. Specific washout periods:Nitrosoureas or mitomycin C (within 6 weeks); oral fluoropyrimidines or small molecule targeted drugs (within 2 weeks); traditional Chinese medicine with anti-tumor indications (within 2 weeks).\n15. Toxicity Recovery: Failure to recover from prior anticancer therapy toxicities to ≤ Grade 1 (per CTCAE v6.0), except for toxicities deemed safe by the Investigator (e.g., alopecia, Grade 2 peripheral neuropathy, hypothyroidism stable on hormone replacement).\n16. IL-2\u002FIL-15 Agonists: Receipt of IL-2 or IL-15 agonist therapy within 4 weeks prior to the first dose.\n17. Immunomodulators: Receipt of immunomodulatory drugs (including but not limited to thymosin, interferon) within 2 weeks prior to the first dose.\n18. Corticosteroids\u002FImmunosuppressants: Receipt of systemic corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive therapies within 2 weeks prior to the first dose. Exceptions:Use of topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids; short-term prophylactic use (e.g., contrast allergy prevention).\n19. Tuberculosis: Active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis \\> 1 year ago without adequate standard treatment.\n20. Active Infection: Serious infection requiring intravenous antibiotics or hospitalization within 4 weeks prior to the first dose.\n21. Viral Infections: Active viral infections, including:\n\n    Active hepatitis B (HBsAg or HBcAb positive and HBV DNA \\> upper limit of normal).\n\n    Active hepatitis C (HCV antibody positive and HCV RNA \\> upper limit of normal).\n\n    Human Immunodeficiency Virus (HIV) infection. Syphilis infection. Note: Patients receiving prophylactic antiviral therapy (excluding interferon) are permitted.\n22. Vaccinations: Receipt of live or attenuated live vaccines within 4 weeks prior to the first dose or anticipated receipt during the study period.\n23. Other: Any other severe physical or psychiatric illness, laboratory abnormality, or other condition that, in the judgment of the Investigator, would increase the risk to the participant, interfere with study results, or make participation inappropriate.",{"count":212,"type":22},14,[84],"This is a Phase I, multicenter, single-arm, open-label clinical study designed to evaluate the safety and tolerability of JL19001 Injection as monotherapy (Phase Ia) or in combination with standard therapy (Phase Ib) in patients with AST and r\u002Fr B-NHL. Only the Phase Ia protocol design is registered at this time. A total of 6 dose cohorts are planned for Phase Ia, i.e., 1, 5, 10, 15, 20, and 25 μg\u002Fkg, with the administration route being subcutaneous injection. A traditional 3 + 3 dose escalation design will be used. The MTD and Recommended Maximum Add-on Dose (RMAD) for JL19001 Injection will be determined.",[216,217,218,28],"Malignancies","Solid Malignant Tumor","NHL (Non-Hodgkin Lymphoma)","2026-05-18",{"date":221,"type":33},"2026-05-22",{"date":223,"type":22},"2026-05",{"date":225,"type":22},"2030-05",{"name":227,"class":203},"Jecho Biopharmaceuticals Co., Ltd.",{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":41},"100628898","phase-1-qls5212-for-participants-with-advanced-solid-tumors-100628898","NCT07467629","QLS5212 for Participants With Advanced Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS5212 Monotherapy in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Being able to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the patient's disease.\n* Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens.\n* Age ≥ 18 years old.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* For Dose Escalation, patients with histologically diagnosed unresectable, locally advanced, or metastatic solid tumors.\n* Life expectancy ≥ 3 months.\n* Measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 criteria and documented by CT and\u002For MRI.\n\n  7\\. Acceptable laboratory parameters:\n  1. Absolute neutrophil count ≥ 1,500\u002FμL.\n  2. Platelet count ≥ 100 × 1000\u002FμL\n  3. Hemoglobin ≥ 9.0 g\u002FdL.\n  4. Albumin ≥ 3 g\u002FdL.\n  5. ALT\u002FAST ≤ 3.0 × ULN.（for patients with hepatic metastases, ALT and AST ≤ 5 × ULN.）\n  6. Total bilirubin ≤ 1.5 ULN or ≤ 3 x ULN for patients with Gilbert's disease.\n  7. a calculated or measured creatinine clearance ≥60 mL\u002Fminute.\n* Identification of an archival tumor sample (i.e., tissue block \\[formalin-fixed paraffin-embedded\\] or a series of approximately 10-15 slides).\n\nExclusion Criteria:\n\n* History of other primary malignancies, except: Basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, or papillary thyroid cancer that has been definitively treated with no evidence of recurrence; Other malignancies that have been adequately treated and remain disease-free for ≥3 years prior to first study dose;\n* Untreated or active brain metastases, including leptomeningeal carcinomatosis;\n* Prior systemic anti-cancer therapy within specified windows;\n* Prior treatment with Monomethyl auristatin E (MMAE)- or Monomethylauristatin F (MMAF)-based antibody-drug conjugates (e.g., enfortumab vedotin, disitamab vedotin, tisotumab vedotin) or any TPBG-targeted therapy;\n* Clinically significant cardiovascular disease;\n* Uncontrolled systemic infection or active tuberculosis;\n* Active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years;\n* Active interstitial lung disease (ILD) or suspected ILD that cannot be ruled out by imaging at screening.",{"count":50,"type":22},[84],"This is a Phase 1, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of intravenously administered QLS5212 in participants with unresectable locally, advanced or metastatic cancer.",[28],"2026-05-17",{"date":241,"type":33},"2026-05-19",{"date":243,"type":33},"2026-05-11",{"date":245,"type":22},"2028-04-05",{"name":247,"class":203},"Qilu Pharmaceutical Co., Ltd.",{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":23,"phases":258,"briefSummary":259,"conditions":260,"keywords":265,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":282},"100595891","phase-1-aventine-1-study-of-avzo-1418-as-a-single-agent-and-in-combination-therapy-in-patients-with-locally-advanced-or-metastatic-solid-tumors-avzo-1418-1001-100595891","NCT07038343","AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)","A Phase 1\u002F2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors","Key Inclusion Criteria\n\n* Patient must be an adult, between 18 and 75 years of age with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \\> 3 months.\n* Patients with histologically or cytologically confirmed locally advanced\u002Fmetastatic malignancies for tumor types of preferred indications:\n\n  o Locally advanced or metastatic epithelial solid tumors (as specified in the protocol).\n* Measurable disease as assessed by Investigator using RECIST v1.1.\n* Agree to provide molecular test report results to confirm eligibility and archival tumor samples and\u002For fresh biopsy, as applicable.\n* Other protocol-defined Inclusion criteria apply.\n\nKey Exclusion Criteria\n\n* Uncontrolled hypertension.\n* Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.\n* History of drug-induced interstitial lung disease (ILD).\n* History of any serious cardiovascular condition.\n* Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.\n* History of a solid organ transplant.\n* Other protocol-defined Exclusion criteria apply.","75 Years",{"count":257,"type":22},480,[84,25],"This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.",[28,188,189,261,262,263,190,264],"Lung Cancers","Epithelial Tumor","Biliary Tract Cancer (BTC)","Nasopharyngeal Cancers",[192,193,188,266,267,268,190,269,270,271,272,273,274],"Lung Cancer","Epithelial Solid Tumors","Biliary Tract Cancer","SCLC","HER3","EGFR","BTC","Small Cell Lung Cancer","NSCLC",{"date":276,"type":33},"2026-05-13",{"date":278,"type":33},"2025-06-04",{"date":280,"type":22},"2030-12",{"name":202,"class":203},18,{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":298,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":4},"100639231","phase-1-safety-tolerability-and-preliminary-antitumor-activity-of-cationic-peptide-il22bp-mrna-in-advanced-solid-tumors-100639231","NCT07583654","Safety, Tolerability, and Preliminary Antitumor Activity of Cationic Peptide-IL22BP mRNA in Advanced Solid Tumors","A Clinical Trial of Cationic Peptide-IL22BP mRNA for Safety, Tolerability, and Preliminary Antitumor Activity in Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Male or female patients aged ≥18 years and ≤70 years.\n* Histopathologically confirmed advanced recurrent\u002Fmetastatic malignant solid tumors that are refractory to second-line treatment and have no available standard clinical therapeutic options (e.g., advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, malignant melanoma, etc.).\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Expected overall survival ≥3 months.\n* Interval from the last chemotherapy, radiotherapy, or surgery ≥28 days.\n* Interval from the last use of nitrosourea or mitomycin C ≥6 weeks.\n* Adequate organ function, defined by the following laboratory parameters within 14 days prior to enrollment:\n* Hemoglobin ≥90 g\u002FL (no blood transfusion within 14 days).\n* Absolute neutrophil count \\>1.5 × 10⁹\u002FL.\n* Platelet count ≥80 × 10⁹\u002FL.\n* Total bilirubin ≤1.5 × upper limit of normal (ULN).\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × -ULN in case of liver metastasis).\n* Creatinine clearance ≥60 mL\u002Fmin (calculated by Cockcroft-Gault formula).\n* Left ventricular ejection fraction (LVEF) ≥50%.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Participation in another investigational drug clinical trial within 4 weeks.\n* Tumor located adjacent to major blood vessels or trachea.\n* Uncontrolled cardiac clinical symptoms or diseases, including New York Heart Association (NYHA) Class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular\u002Fventricular arrhythmias requiring treatment or intervention.\n* Female patients who are pregnant or lactating.\n* Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE version 5.0), active human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection.\n* History of uncontrollable psychoactive substance abuse or presence of mental disorders.\n* Any active autoimmune disease or history of autoimmune disease, including but not limited to uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism.\n* Subjects with vitiligo or childhood asthma in complete remission (no adult intervention required) are eligible; subjects with asthma requiring bronchodilator therapy are excluded.\n* Receiving immunosuppressive therapy.\n* History of drug abuse or known medical, psychological, or social conditions that interfere with study compliance (e.g., alcoholism or illicit drug addiction).\n* Known hypersensitivity, allergy, or intolerance to the study drug CPIL22BP mRNA (including any excipients), or history of severe allergic reactions to any drugs, foods, or vaccines (e.g., anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local Arthus reaction, etc.).\n* Female subjects planning pregnancy, or male subjects whose partner plans pregnancy, from screening until 12 months after the last study drug injection.\n* Any concomitant disease that, in the investigator's judgment, may seriously compromise patient safety or prevent the subject from completing the study.","70 Years",{"count":282,"type":22},[84],"The goal of this phase 1 clinical trial is to evaluate the safety, tolerability, and preliminary antitumor activity of a peptide-delivered IL-22BP biotherapy in patients with advanced solid tumors. The main questions it aims to answer are:\n\nIs the IL-22BP formulation safe and tolerable? Does the IL-22BP formulation show preliminary antitumor activity?",[295,28,296,297],"mRNA Vaccine","Peptides","Cancer Metastatic",[299,300,301,302],"mRNA vaccine","Cancer metastasis","Solid tumor","IL-22","2026-05-06",{"date":276,"type":33},{"date":306,"type":22},"2026-05-30",{"date":308,"type":22},"2027-12-30",{"name":310,"class":40},"West China Hospital",{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":290,"enrollmentInfo":318,"targetDuration":4,"studyType":23,"phases":320,"briefSummary":321,"conditions":322,"keywords":325,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":332,"leadSponsor":333,"locationsCount":4},"100637874","phase-1-safety-tolerability-and-preliminary-antitumor-activity-of-non-cationic-peptide-cd47-sirna-in-advanced-solid-tumors-100637874","NCT07583914","Safety, Tolerability, and Preliminary Antitumor Activity of Non-Cationic Peptide-CD47 siRNA in Advanced Solid Tumors","A Clinical Trial of Non-cationic Peptide-CD47 siRNA for Safety, Tolerability, and Preliminary Antitumor Activity in Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Male or female patients aged ≥18 years and ≤70 years.\n* Histopathologically confirmed advanced recurrent\u002Fmetastatic malignant solid tumors that are refractory to second-line treatment and have no available standard clinical therapeutic options (e.g., advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, malignant melanoma, etc.).\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Expected overall survival ≥3 months.\n* Interval from the last chemotherapy, radiotherapy, or surgery ≥28 days.\n* Interval from the last use of nitrosourea or mitomycin C ≥6 weeks.\n* Adequate organ function, defined by the following laboratory parameters within 14 days prior to enrollment:\n* Hemoglobin ≥90 g\u002FL (no blood transfusion within 14 days).\n* Absolute neutrophil count \\>1.5 × 10⁹\u002FL.\n* Platelet count ≥80 × 10⁹\u002FL.\n* Total bilirubin ≤1.5 × upper limit of normal (ULN).\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × ULN in case of liver metastasis).\n* Creatinine clearance ≥60 mL\u002Fmin (calculated by Cockcroft-Gault formula).\n* Left ventricular ejection fraction (LVEF) ≥50%.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Participation in another investigational drug clinical trial within 4 weeks.\n* Tumor located adjacent to major blood vessels or trachea.\n* Uncontrolled cardiac clinical symptoms or diseases, including New York Heart -Association (NYHA) Class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular\u002Fventricular arrhythmias requiring treatment or intervention.\n* Female patients who are pregnant or lactating.\n* Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE version 5.0), active human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection.\n* History of uncontrollable psychoactive substance abuse or presence of mental disorders.\n* Any active autoimmune disease or history of autoimmune disease, including but not limited to uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism. Subjects with vitiligo or childhood asthma in complete remission (no adult intervention required) are eligible; subjects with asthma requiring bronchodilator therapy are excluded.\n* Receiving immunosuppressive therapy.\n* History of drug abuse or known medical, psychological, or social conditions that interfere with study compliance (e.g., alcoholism or illicit drug addiction).\n* Known hypersensitivity, allergy, or intolerance to the study drug NCP-CD47 siRNA (including any excipients), or history of severe allergic reactions to any drugs, foods, or vaccines (e.g., anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local Arthus reaction, etc.).\n* Female subjects planning pregnancy, or male subjects whose partner plans pregnancy, from screening until 12 months after the last study drug injection.\n* Any concomitant disease that, in the investigator's judgment, may seriously compromise patient safety or prevent the subject from completing the study.",{"count":319,"type":22},9,[84],"This study evaluates a non-cationic peptide-CD47 siRNA nanocomplex for refractory advanced solid tumors. The candidate blocks the CD47-SIRPα \"don't eat me\" signal, repolarizes tumor-associated macrophages, and restores antitumor immunity. Using a 3+3 dose-escalation design (25, 50, 100 μg), the investigators aim to define the MTD and RP2D, providing a novel therapeutic approach and clinical evidence for siRNA drug development.",[28,323,324],"Metastases","Head and Neck Cancer",[326,327,300,328,329],"Solid Tumor","siRNA","Progress-free survival","Overall survival",{"date":276,"type":33},{"date":306,"type":22},{"date":308,"type":22},{"name":310,"class":40},{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":255,"enrollmentInfo":340,"targetDuration":4,"studyType":23,"phases":342,"briefSummary":343,"conditions":344,"keywords":346,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":356},"100639207","phase-1-phase-i-open-labeled-dose-escalation-dose-expansion-study-evaluating-the-safety-tolerance-pharmacokinetics-and-activity-of-iuab190708-in-patients-with-advanced-or-recurrent-solid-tumors-100639207","NCT07584954","Phase I, Open-labeled, Dose-escalation, Dose-expansion Study Evaluating the Safety, Tolerance, Pharmacokinetics, and Activity of IUAb190708 in Patients With Advanced or Recurrent Solid Tumors","Inclusion Criteria:\n\n1. Male or female adult, age 18 - 75, understanding and voluntarily signing an informed consent form\n2. A histologically confirmed diagnosis of Metastatic or locally advanced solid tumors, ineffective management of therapeutic regimen or currently no approved treatment available for the tumor, or unsuitable or refusing to receive standard treatment\n3. In Phase Ia, for tumors with approved indications of anti PD-1\u002FPD-L1 treatment, unrestricted to PD-L1 expression; for tumors that have not yet been approved for indications, positive expression of PD-L1 required. In Phase Ib, positive expression of PD-L1 is required\n4. Subjects should provide fresh or archived tissue samples\n5. Subjects must have at least one measurable lesion per iRECIST\n6. Life expectancy ≥ 3 months\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1\n8. Adequate organ function, and no blood transfusion, erythropoietin (EPO), and granulocyte colony-stimulating factor at least 14 days before the study drug administration\n9. All the female of child-bearing age must have a negative pregnancy test (unine or serum) during screening period and agree to use effective medical contraception from written informed consent to at least 6 months after the last administration of the study drug. Male partners also must agree to use effective medical contraception from written informed consent to at least 6 months after the last administration of the study drug.\n\nExclusion Criteria:\n\n1. Serious\u002Factive infection or infection requiring intravenous antibiotic treatment within 4 weeks prior to the first dose of the study drug\n2. Receiving nitrosourea and mitomycin C within 6 weeks prior to the first dose of the study drug; receiving oral fluorouracil derivatives or small molecule targeted drugs within 2 weeks prior to the first dose or 5 half-lives of the drug (whichever is longer); receiving endocrine therapy, Immunotherapy, or Traditional Chinese Medicine for anti-tumor indications within 2 weeks prior to the first dose of the study drug; receiving other anti-tumor therapies, such as chemotherapy, radiation, biotherapy, besides as described above treatments, within 4 weeks prior to the first dose of the study drug\n3. Having other primary active malignant tumors within 5 years prior to the first dose of the study drug\n4. Having clinically significant cardiovascular diseases,\n5. Primary tumors of central nervous system or CNS metastatic tumors that have failed local treatment. For asymptomatic or clinically stable symptoms without the need for steroid hormones and other treatments for CNS metastasis lasting ≥ 28 days, CNS tumors under stable condition, including new CNS metastasis without any syndrome, confirmed by imaging during screening period can be enrolled.\n6. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients\n7. History of allogeneic organ transplant.\n8. Known history of infection with Human Immunodeficiency Virus (HIV) or other acquired or congenital immunodeficiency.\n9. Patients with serious psychiatric or medical condition that could interfere with medication adherence.\n10. Receiving systemic corticosteroid therapy (prednisone \\>10 mg\u002Fday or Bioequivalent dose of hydrocortisone) within 2 week prior to the first dose of trial treatment or receiving any other form of systemic immunosuppressive medication, except the condition as described below: treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids, or short-term (≤7 days) use of glucocorticoids for prophylactic treatment.\n11. Active or history of autoimmune disease that requires systemic treatment within 2 years prior to enrollment (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). But the subjects with the following diseases are allowed to be enrolled: Type I diabetes with stable condition after using fixed dose insulin; Autoimmune hypothyroidism that only requires hormone replacement therapy.\n12. History of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, interstitial pneumonia or evidence of active pneumonia detected during chest CT scan screening.\n13. Having experienced immune related adverse events of ≥ 3 grade during receiving any immunotherapy medication in the past.\n14. Adverse reactions from previous anti-tumor treatments have not yet recovered to ≤1 grade per CTCAE 5.0 (except alopecia and other adverse reactions that the investigator determines that there is no safety risk)\n15. Underwent major surgery within 4 weeks prior to the first dose of the study drug, or not fully recovered after surgery, or planned surgery within the expected participation time of the subject in the study or within 4 weeks after the last dose of the study drug.\n16. Treponema pallidum antibody positive; active hepatitis B (HBsAg positive with HBV-DNA\\>500IU\u002FmL); active hepatitis C (except subjects with HCV antibody positive and HCV-RNA \\\u003Clower limit of clinical research organization).\n17. Subjects with history or current evidence of any clinical condition or laboratory abnormality or other reasons are not suitable to participate in this clinical study by the investigator.\n18. Female who are pregnant or breastfeeding\n19. Subjects with history of other serious systemic diseases are not suitable to participate in this clinical study by the investigator.",{"count":341,"type":22},90,[84],"This study is to evaluate a novel cytotoxic anti-PD-L1, IUAb190708, for the treatment of tumor",[28,345],"Solid Tumor Cancer Treatment With Immunotherapy",[347,348],"cytotoxic antibody","PD-L1",{"date":276,"type":33},{"date":351,"type":33},"2024-06-18",{"date":353,"type":22},"2028-06-30",{"name":355,"class":203},"Jun Zhou",6,{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":23,"phases":366,"briefSummary":367,"conditions":368,"keywords":374,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":388},"100625585","phase-1-phase-i-study-of-sys6043-in-patients-with-advancedmetastatic-solid-tumors-100625585","NCT07424547","Phase I Study of SYS6043 in Patients With Advanced\u002FMetastatic Solid Tumors","Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6043 in Patients With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\nMajor:\n\n* Aged ≥18 years old (on the date of signing the ICF).\n* Advanced\u002Funresectable or metastatic solid tumors confirmed by histology or cytology, disease recurrence or progression during or after systemic standard of care, and should be intolerant of or have no available standard of care therapy.\n* Have at least one measurable lesion, according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1). Participants with metastatic castration-resistant prostate cancer (mCRPC) who have only metastases to bone will be evaluated through discussion with the sponsor's medical monitor, before determining whether they can be enrolled.\n* Expected life expectancy of ≥ 3 months.\n* ECOG performance status of 0-1 and no worsening of the score within 28 days prior to enrollment.\n* LVEF ≥ 50% as shown by ECHO or MUGA within 28 days prior to enrollment.\n\nExclusion Criteria:\n\nMajor:\n\n* Prior B7-H3 targeted therapy.\n* Previously received drug therapy with topoisomerase inhibitor antibody-drug conjugate (e.g., trastuzumab deruxtecan).\n* Symptomatic congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II-IV) or a history of severe arrhythmia requiring treatment.\n* History of myocardial infarction or unstable angina within 6 months prior to enrollment.\n* Based on the results of three 12-lead electrocardiogram (ECG) examinations, the mean QT interval (QTcF) corrected by the Fridericia formula for both males and females is prolonged to \\>470 ms.\n* Unable or unwilling to discontinue concomitant medications known to prolong the QT interval.\n* History of interstitial lung disease (e.g., ILD\u002Fnon-infectious pneumonia requiring glucocorticoid treatment in the past), or currently have interstitial lung disease, or are suspected to have such diseases through imaging examinations during screening.\n* History of underlying lung disorders, including but not limited to pulmonary embolism within 3 months prior to the start of study treatment, severe asthma, severe COPD, restrictive pulmonary disease, and other clinically significant lung injuries or requiring supplemental oxygen.\n* Any autoimmune diseases, connective tissue disorders, or inflammatory diseases involving the lungs recorded or suspected during screening (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).\n* Presence of uncontrolled infection requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs.\n* Active and clinically significant bacterial, fungal, viral infection, or Hepatitis C infection at screening (HCV antibodies test positive and HCV-RNA levels higher than the lower limit of quantification or 1000 copies\u002FmL (whichever is lower); HIV antibody positive or syphilis antibody positive (with confirmation)..\n* HBsAg positive and HBV-DNA above the lower limit of quantification or 1,000 copies\u002FmL (500 IU\u002FmL) (whichever is lower). Liver tumor: For participants with liver metastases and HBV infection, HBV DNA must be \\\u003C2000 IU\u002FmL before the first dose. Participants who are HBsAg-positive and\u002For HBV DNA-positive should receive at least 2 weeks of anti-Hepatitis B virus treatment prior to the first dose and be willing to continue treatment during the study.\n* Lactating women (women who are willing to temporarily discontinue breastfeeding will also be excluded), or women confirmed to be pregnant by pregnancy test within 7 days prior to enrollment.\n* Presence of spinal cord compression or clinically active brain metastasis, and\u002For meningeal metastases, defined as untreated, symptomatic, or requiring corticosteroids or anticonvulsants.",{"count":365,"type":22},386,[84],"The goal of this clinical trial is to learn if investigational drug called SYS6043 works in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies. The main goals of the study are to understand how safe SYS6043 is, what side effects it may cause, and what dose can be given safely. Researchers will also study how the drug moves through the body and whether the immune system reacts to it. In addition, the study will look for early signs that SYS6043 may help slow or shrink tumors and explore whether the amount of a tumor protein called B7-H3 is related to how well the treatment works.\n\nParticipants will:\n\n* Provide written informed consent\n* Undergo screening tests to ensure they are eligible for study treatment\n* Attend all required study visits and receive SYS6043 by intravenous infusion once every 3 weeks (Q3W), with 21 days as one treatment cycle until the study doctor determines that study treatment should be stopped based on how well a participant is doing on treatment.\n* Have safety follow-up (SFU), and long-term follow-up.\n* Be followed until progression.",[369,28,370,371,273,372,373],"Cancer","Advanced Metastatic Cancer","Prostate","Ovarian Cancer","Breast Cancer",[375,376,377,378],"ovarian cancer","breast cancer","small cell lung cancer","prostate cancer","2026-04-06",{"date":381,"type":33},"2026-04-07",{"date":383,"type":33},"2026-03-03",{"date":385,"type":22},"2030-04",{"name":387,"class":203},"Conjupro Biotherapeutics, Inc.",5,{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":255,"enrollmentInfo":396,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":403,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":41},"100568506","a-clinical-study-of-personalized-self-dc-vaccine-targeting-neoantigen-in-treatment-of-advanced-solid-tumor-100568506","NCT06682117","A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor","Neo-DCV-001","Inclusion Criteria:\n\n1. 18-75 years.\n2. Histologically or cytologically confirmed advanced solid tumor, with at least one tumor lesion measurable (basis RECIST1.1 standard).\n3. HLA typing was HLA-A0201\u002F1101\u002F2402 (containing at least one of the typing, according to the central laboratory issued).\n4. Paraffin-embedded tumor tissue sections or biopsy tumor tissues within 3 years (for tumors with easy sampling).\n5. Before enrollment, systemic standard treatment failure or standard treatment intolerance, and meet the following tumor requirements : new antigen positive（head and neck tumors, non-small cell lung cancer without driver genes (no EGFR sensitive mutation \u002F ALK fusion positive), esophageal squamous cell carcinoma).\n6. Voluntary to participate in clinical research ; the person or legal guardian fully understands and is informed of this study and sign the informed consent; willing to follow and be able to complete all test procedures;\n7. ECOG score 0-1.\n8. Have a venous access to meet single collection or venous blood collection;\n9. Expected survival time ≥ 6 months.\n10. Subjects were willing to study the use of reliable contraceptive methods during treatment and within 3 months after the end of treatment, and women of childbearing age.\n11. Have adequent organ functions.\n12. Before administration of Neo-DCV injection : 1) any chemotherapy, targeted drugs, immune checkpoint inhibitors, other clinical trial research drugs, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments received have passed the 4-week elution period, and the toxic and side effects returned to grade 1 or lower (except for alopecia, vitiligo and other tolerable events judged by researchers) ; 2) If undergoing major surgery within 3 weeks, the adverse reactions have returned to grade 1 or lower.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Patients with a history of severe immediate allergies to the cells and any drugs used in this study.\n3. Those with a history of organ transplantation.\n4. Known central nervous system metastasis.\n5. Any active autoimmune disease or any autoimmune disease that has been determined by the researchers to be unsuitable for this study.\n6. Uncontrolled concomitant diseases or infectious diseases, such as the need for systemic antibiotics within 2 weeks before enrollment.\n7. Suffering from severe liver and kidney function damage (liver, kidney treatment but still not controllable, biochemical indicators can not meet the inclusion criteria of NO.11, or can not control the diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or poor drug control of hypertension ( systolic blood pressure more than 160mmHg and\u002For diastolic blood pressure more than 90mmHg), or with clinical Bed meaning (e.g. activity ) of cardiovascular and cerebrovascular diseases, such as cerebrovascular accident (6 months before signing informed consent) unstable angina, myocardial infarction (within 6 months before signing informed consent), unstable angina, New York Heart Association, or any circumstances which, in the opinion of the researcher, may increase the risk of the subject or interfere with the results of the test.\n8. Subjects planned to receive sugar within 4 weeks before the first Neo-DCV injection and during the study period due to certain conditions.\n\n   Corticosteroids (prednisone or the same drug dose less than 10mg\u002Fday ) or other immunosuppressive agents were excluded.\n9. Subjects were scheduled to receive Neo-DCV injection within 4 weeks before the first administration and during the study period due to certain conditions.\n10. The researchers assessed that the subjects were unable or unwilling to comply with the requirements of the study protocol.\n11. The defects of antigen presentation, antigen recognition and cell killing related genes were detected by sequencing.\n12. There was a history of other malignant tumors in the past 5 years, except for curable basal cell carcinoma, papillary thyroid carcinoma, and uterus.\n13. Subjects have any disease or medical condition that may affect the evaluation of the safety or efficacy of the study drug.",{"count":319,"type":22},[52],"This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors.",[400,401,402,28],"Treatment","Neoantigen","Vaccine",[404,405,406],"advanced solid tumors","DC vaccine","neoantigen","2026-03-28",{"date":409,"type":33},"2026-04-02",{"date":411,"type":33},"2024-11-15",{"date":413,"type":22},"2026-12-30",{"name":415,"class":40},"Fudan University",{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":23,"phases":425,"briefSummary":426,"conditions":427,"keywords":429,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":212},"100626864","phase-1-in10018-in-combination-with-rnk08954-for-the-treatment-of-krasg12d-mutation-positive-locally-advanced-or-metastatic-solid-tumors-100626864","NCT07441174","IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors","A Multicenter, Open-Label, Phase Ib\u002FII Clinical Trial of IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* 1\\. Voluntarily participate in the study after being fully informed, sign the written ICF, and agree to comply with the procedures specified in the protocol.\n* 2\\. Male or female aged ≥18 years at the time of signing the ICF.\n* 3\\. Subjects with pathologically confirmed locally advanced or metastatic solid tumors.\n* 4\\. Subjects confirmed to be KRASG12D mutation-positive in tumor tissue samples. Subjects may use historical results from local laboratories (within 2 years before signing the ICF).\n\nNote: Test results must be provided by a laboratory certified by the Clinical Laboratory Improvement Amendments (CLIA) or an equivalent certification, a third-party laboratory recognized by the investigator, or the pathology department of grade A tertiary hospital.\n\n* 5\\. Requirements for tumor type are as follows:\n\n  1. Phase Ib: Subjects with locally advanced or metastatic solid tumors who have documented radiologically disease progression, and are intolerant to standard treatment, or have no standard treatment, or have failed to standard treatment.\n  2. Phase II Cohort 1: Subjects with locally advanced or metastatic PDAC who have previously received gemcitabine- or nab-paclitaxel-based chemotherapy regimens or FOLFIRINOX\u002FmFOLFIRINOX standard treatment and failed to standard treatment (have received at least first-line standard therapy and failed to standard treatment);\n  3. Phase II Cohort 2: Subjects with locally advanced or metastatic solid tumors who have documented radiologically disease progression and are intolerant to standard treatment, or have no standard treatment, or have failed to standard treatment (Selected tumor types will be determined based on prior study results).\n* 6\\. Presence of at least 1 measurable lesion assessable by computed - tomography (CT) or magnetic resonance imaging (MRI) according to RECIST Version 1.1. For lesions previously treated with radiotherapy or other local treatments, radiological confirmation of disease progression is required before they can be considered measurable lesions.\n* 7\\. ECOG performance status score of 0 or 1.\n* 8\\. Life expectancy of at least 3 months (assessed by the investigator).\n* 9\\. Laboratory tests within 7 days before the first dose confirm adequate bone marrow, liver, kidney, and coagulation function reserves, and no blood transfusion or blood products have been received within 14 days before the relevant tests:\n\n  1. Platelets ≥100×10⁹\u002FL, and no platelet transfusion or thrombopoietin (TPO) treatment has been received within 14 days before the screening blood routine test.\n  2. Hemoglobin ≥90 g\u002FL, and no blood transfusion, red blood cell transfusion, or erythropoietin (EPO) treatment has been received within 14 days before the screening blood routine test.\n  3. Neutrophil count ≥1.5×10⁹\u002FL, and no colony-stimulating factor (CSF) has been used within 14 days before the screening blood routine test.\n  4. Creatinine clearance (Clcr) estimated by the Cockcroft-Gault (C-G) formula ≥60 mL\u002Fmin, or estimated glomerular filtration rate (eGFR) estimated by the Modification of Diet in Renal Disease (MDRD) equation ≥60 mL\u002Fmin.\n  5. Urine protein negative or weakly positive (±); or urine protein 1+, but urine protein-to-creatinine ratio (UPCR) in random morning urine \\\u003C0.5 or 24-hour urine protein quantification \\\u003C0.5 g\u002F24 h.\n  6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×Upper Limit of Normal (ULN) (≤5×ULN if liver metastasis exists). g) Total bilirubin ≤1.5×ULN (≤3×ULN is allowed for subjects with Gilbert's syndrome).\n  7. Prothrombin time and activated partial thromboplastin time ≤1.5×ULN, International Normalized Ratio (INR) ≤1.5. For subjects receiving anticoagulant therapy, INR \\\u003C3.0 or within the target range of anticoagulant therapy (if applicable).\n* 10\\. Female subjects of childbearing potential must agree to abstain from sexual intercourse or use effective contraceptive methods from the time of signing the ICF until 6 months after the last dose of study drug. Acceptable contraceptive methods include: oral, injectable, or implantable hormonal contraception; intrauterine device or intrauterine system; male condom with spermicide or occlusive cap (diaphragm or cervical\u002Fvaginal cap).\n* 11\\. Male subjects must agree to abstain from sexual intercourse, undergo sterilization surgery, or use effective contraceptive methods from the time of signing the ICF until 6 months after the last dose of study drug.\n\nNote: Effective contraceptive methods include: use of a male condom, with the female partner also using hormonal contraception or an intrauterine device (used for at least 4 weeks before administration); use of a male condom, with the female partner also using a diaphragm with spermicide or a cervical\u002Fvaginal cap.\n\nExclusion Criteria:\n\n* 1\\. Previous treatment with KRASG12D inhibitors. Note: Except for subjects in Phase Ib, who may have received previous treatment with KRASG12D inhibitors.\n* 2\\. Previous treatment with focal adhesion kinase (FAK) inhibitors.\n* 3\\. Received any anti-cancer drug treatment (including cytotoxic therapy, targeted therapy, biological therapy, or hormonal therapy other than alternative therapy) or other investigational drug treatment and radiotherapy within 14 days before the first dose.\n* 4\\. Have other KRAS mutations (excluding KRASG12D mutation), and have other positive mutation sites with available marketed targeted drugs.\n* 5\\. Subjects with known spinal cord compression symptoms, unstable or symptomatic\u002Fprogressive central nervous system (CNS) metastasis, or meningeal metastasis. Subjects with a history of brain metastasis who are clinically and radiologically stable (i.e., no progression of CNS disease confirmed by two consecutive brain MRI or CT scans (if MRI is not suitable) with an interval of at least 4 weeks) may be enrolled (if the subject has previously received radiotherapy for brain metastasis, the MRI or CT scan must be performed at least 4 weeks after the last brain radiotherapy). For subjects who have received corticosteroid treatment, corticosteroids must have been discontinued for at least 2 weeks before the first dose of study drug. For subjects receiving anti-epileptic treatment, their medication dose must have been stable for at least 2 weeks.\n* 6\\. Any of the following cardiovascular conditions:\n\n  1. Congestive heart failure with New York Heart Association (NYHA) functional class II or higher.\n  2. Severe arrhythmia and left bundle branch block requiring drug treatment.\n  3. Acute myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass surgery within 6 months before the first dose.\n  4. Left ventricular ejection fraction (LVEF) \\\u003C50%.\n  5. Prolonged corrected QT interval (QTcF) by Fridericia's formula at rest, with an average QTc interval \\>480 ms measured by three consecutive ECGs, or risk factors for torsades de pointes, such as clinically significant hypokalemia, family history of long QT syndrome, or familial arrhythmia (e.g., Pre-excitation Syndrome) as judged by the investigator.\n  6. Uncontrolled hypertension (defined as systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥100 mmHg after standardized antihypertensive drug treatment).\n  7. Deep vein thrombosis (other than implantable venous access port or catheter-related thrombosis) or pulmonary embolism within 6 months prior to the first dose of study treatment.\n* 7\\. Subjects with stroke or other severe cerebrovascular diseases (e.g., acute cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage) within 12 months prior to the first dose of study treatment.\n* 8\\. Subjects with interstitial lung disease or any active infection requiring systemic treatment within 14 days prior to the first dose of study treatment, including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.\n* 9\\. Subjects with active autoimmune diseases (e.g., autoimmune thyroid disease, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease) requiring systemic treatment (including disease-modifying drugs, corticosteroids, or immunosuppressants) within the past 2 years. Hashimoto's thyroiditis, vitiligo, and psoriasis that do not require systemic treatment are excluded. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n* 10.The investigator judges that the subject has a history or evidence of substance abuse, or has medical, psychological, or social conditions that may interfere with study participation or evaluation of study results.\n\nNote: The following conditions are not recommended for enrollment, including but not limited to: 1) Presence of pleural effusion, pericardial effusion, or ascites that is poorly controlled and requires clinical management; 2) Active bleeding such as hemoptysis or gastrointestinal bleeding during the screening period, subjects with only a small amount of blood in sputum are allowed to enroll; 3) Received live vaccines or attenuated live vaccines within 28 days prior to the first dose of study treatment.\n\n* 11.Subjects with gastrointestinal (GI) disorders that may significantly impair the oral administration, absorption, or metabolism of the study drug, including dysphagia, refractory nausea and vomiting, malabsorption syndrome, gastrectomy or small bowel resection that impairs the oral absorption or metabolism of the study drug, symptomatic inflammatory bowel disease, and partial or complete intestinal obstruction.\n\nNote: Subjects with clinical or radiological evidence of intestinal obstruction, or those who developed intestinal obstruction within the previous 3 months with unresolved underlying cause are not recommended for enrollment.\n\n* 12.The subject has not recovered from the toxicity of previous anti-tumor treatment (except for alopecia and pigmentation), defined as not recovered to NCI CTCAE v5.0 ≤Grade 1 (≤Grade 2 for peripheral neuropathy).\n* 13.The subject has undergone major surgery within 4 weeks prior to the first dose of study drug or has not fully recovered from previous surgical treatment. For percutaneous liver biopsy and other needle biopsies, a 14-day washout period is required before the first dose of study treatment.\n\nNote: Subjects expected to undergo major surgery or those who need to interrupt study medication for scheduled surgery during the study treatment, should also be excluded.\n\n* 14.The subject has received or plans to receive within 2 weeks before the first dose of study drug treatment:\n\n  1. Drugs that are known to be narrow therapeutic window substrates of CYP3A.\n  2. Drugs that are known to be strong inducers or inhibitors of CYP3A4.\n  3. Drugs that are known to be strong inhibitors of P-glycoprotein.\n  4. Drugs known\u002Fpotentially causing QTc interval prolongation or torsades de pointes (e.g., antiarrhythmic drugs).\n\nNote: For details, refer to Appendix 9 in Section 10.9.\n\n* 15.Pregnant or lactating women.\n* 16.Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥2500 copies\u002FmL or 500 IU\u002FmL, positive for hepatitis C virus (HCV) antibody with HCV ribonucleic acid (HCV RNA) above the lower limit of detection, or positive for human immunodeficiency virus (HIV) antibody.\n* 17.A history of other malignant tumors within 5 years before the first dose, except for cured basal cell carcinoma of the skin, carcinoma in situ (e.g., carcinoma in situ of the breast, squamous cell carcinoma in situ of the skin, cervical carcinoma in situ).\n* 18.Known allergy (such as life-threatening hypersensitivity reaction) or other intolerances to IN10018, RNK08954 or their pharmaceutical excipients; or subjects with severe allergic diathesis.",{"count":424,"type":22},92,[84,25],"This is a multicenter, open-label, Phase Ib\u002FII clinical study. The study includes Phase Ib-Dose Exploration Stage and Phase II - Efficacy Exploration and Determination Stage.",[28,428],"PDAC",[430],"KRASG12D mutation-positive","2026-02-25",{"date":433,"type":33},"2026-02-27",{"date":435,"type":22},"2026-02-28",{"date":437,"type":22},"2031-02-28",{"name":439,"class":203},"InxMed (Shanghai) Co., Ltd.",{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":446,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":448,"phases":4,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":41},"100389683","circulating-tumor-dna-ctdna-for-early-treatment-response-assessment-of-solid-tumors-100389683","NCT04354064","Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors","Inclusion Criteria:\n\n* Eligible healthy donors will be at least 18 years of age.\n\nExclusion Criteria:\n\n* Healthy donors younger than 18 years of age",true,{"count":50,"type":22},"OBSERVATIONAL","Earlier detection of disease recurrence will enable greater treatment options and has strong potential to improve patient outcomes. This project is translational and has the potential to lead to future translational research opportunities, including interventional trials in which therapeutic escalation is offered at the early circulating tumor DNA (ctDNA) molecular residual disease (MRD) detection timepoint. Ultimately, the integration of ctDNA into the clinical workflow has the potential to enhance cancer diagnosis, treatment, surveillance, and prognosis, and guide clinical decision-making in this era of personalized precision medicine.",[451,452,324,453,454,455,373,456,457,28,266,458,459],"Healthy Volunteer","Prostate Cancer","Esophageal Cancer","Genitourinary Cancer","Sarcoma","Colon Cancer","Gastrointestinal Cancer","Skin Cancer","Melanoma","2026-02-17",{"date":462,"type":33},"2026-02-20",{"date":464,"type":33},"2019-05-29",{"date":466,"type":22},"2026-12-31",{"name":468,"class":40},"Washington University School of Medicine",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":23,"phases":478,"briefSummary":479,"conditions":480,"keywords":482,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":494,"leadSponsor":496,"locationsCount":498},"100618892","phase-1-a-first-in-human-study-of-plt012-in-participants-with-solid-tumor-cancers-100618892","NCT07337525","A First in Human Study of PLT012 in Participants With Solid Tumor Cancers","A Phase 1 Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLT012 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Aged at least 18 years and provided written informed consent\n* Histologically or cytologically confirmed advanced solid tumors (except primary CNS malignancies)\n* Has at least one measurable lesion per RECIST v1.1\n* ECOG PS of 0 to 1\n* Life expectancy of ≥ 12 weeks\n* Child-Pugh score of Class A (for hepatocellular carcinoma only)\n* Adequate organ function as defined by protocol-specified laboratory values\n* Not pregnant or breastfeeding\n\nExclusion Criteria:\n\n* Insufficient washout period from prior therapies as defined in the study protocol\n* Ongoing Grade 2 or higher toxicities from prior treatments (with some exceptions)\n* Concurrent or recent (within 2 years) malignancy other than the disease under study (with some exceptions)\n* Uncontrolled HIV, uncontrolled hepatitis B, or uncontrolled acute hepatitis C infections\n* Unstable\u002Funcontrolled or untreated central nervous system (CNS) metastasis\n* Active or recent (within 3 years) autoimmune disease requiring medical treatment\n* Recipient of any organ transplant including allogeneic stem-cell transplant\n* Clinically significant and active cardiovascular disease\n* Known active alcohol or drug abuse\n* Psychiatric disorders that would prohibit the understanding of the Informed Consent Form\n* Ascites requiring therapeutic paracentesis or hepatic encephalopathy requiring medical interventions within the past 6 months (if hepatocellular carcinoma)",{"count":477,"type":22},36,[84],"The goal of this clinical trial is to learn about what doses of PLT012 are safe to use in adults with advanced cancers in solid tumors. It will also learn about how effective different doses of PLT012 are in treating cancer. The main questions it aims to answer are:\n\nWhat adverse events and toxicities (harmful side effects) are associated with different doses of PLT012? What are the blood levels of PLT012 in your body at different timepoints? What effect does PLT012 have on reducing tumor size and\u002For preventing the worsening of cancer? All participants will receive PLT012 and none will receive placebo (a look-alike substance that contains no drug).\n\nParticipants will receive PLT012 by intravenous infusion once every 3 weeks. Treatment with PLT012 can continue until the participant's disease worsens or they cannot tolerate treatment.\n\nFor the first 12 weeks, visits to the clinic will be more frequent (from 1 to 5 times over a 3-week period). After the first 12 weeks, visits will be reduced to once every 3 weeks.",[481,28],"Advanced Malignant Solid Tumor",[483,484,485,486,487,488,489],"Gastrointestinal cancer","Liver metastases","Bladder cancer","Liver cancer","Phase 1","Dose escalation","Advanced solid tumors","2026-02-13",{"date":492,"type":33},"2026-02-18",{"date":490,"type":33},{"date":495,"type":22},"2028-01",{"name":497,"class":203},"Pilatus Biosciences Inc",2,{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":508,"briefSummary":509,"conditions":510,"keywords":512,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":520,"leadSponsor":521,"locationsCount":41},"100609768","feasibility-and-acceptability-of-the-remote-oncology-symptom-assessment-application-100609768","NCT07218874","Feasibility and Acceptability of the Remote Oncology Symptom Assessment Application","ROSA App","Inclusion Criteria:\n\n* Receiving chemotherapy at the UPMC Hillman Cancer Center for any solid tumor cancer at any stage with at least two cycles remaining;\n* age 18 years or older;\n* ability to read and write in English;\n* sufficient performance status to participate in research (e.g., Karnofsky performance status of 60-100%); and\n* owns and uses an Android smartphone or an iPhone capable of running the study apps.\n\nExclusion Criteria:\n\n* under 18 years old; and\n* unable to read and write in English",{"count":507,"type":22},50,[52],"The goal of this study is to determine whether a mobile application that combines real-time sensor data and patient-reported symptoms to trigger care-team contact recommendations is feasible and beneficial for patients receiving chemotherapy. The main questions it aims to answer are:\n\n* Is the mobile application feasible and acceptable to patients?\n* Do the alerts and guidance improve symptom management, quality of life, and engagement with the care team during treatment?\n\nParticipants will:\n\n* Complete a demographic questionnaire at the beginning of the study and quality-of-life and health questionnaires at the beginning, midpoint, and end of study.\n* Complete daily symptom ratings.\n* Wear a Fitbit activity tracker for 90 days.\n* At the end of the study, complete a semi-structured interview to provide feedback on the study.\n* Optional: At the beginning and end of the study, complete an in-person physical function assessment measuring balance (Short Physical Performance Battery).",[369,28,511],"Chemotherapy",[513,514,515],"quality of life","symptom management","smartphone application","2026-02-02",{"date":518,"type":33},"2026-02-04",{"date":516,"type":33},{"date":466,"type":22},{"name":522,"class":40},"University of Pittsburgh",{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":448,"phases":4,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":540,"locationsCount":41},"100613551","implementation-of-the-methylome-in-the-characterization-of-solid-tumors-100613551","NCT07268066","Implementation of the Methylome in the Characterization of Solid Tumors","AMethiST","Inclusion Criteria:\n\n* Confirmed diagnosis of one of the following types of cancer: gliomas, malignant thyroid neoplasms, or endometrial carcinomas (according to the WHO Nomenclature)\n* Availability of adequate material for analysis at the laboratory, specifically availability of at least 3 sections of 10 µm of FFPE\n\nExclusion Criteria:\n\n* no",{"count":531,"type":22},180,"This study aims to investigate the functional consequences of specific methylation changes and to examine the clinical implications of these alterations. Methylation analysis is a powerful tool for understanding the molecular mechanisms of brain tumors and other solid tumors and can help identify new diagnostic and therapeutic targets. By analyzing DNA methylation patterns in tumor tissue, it is possible to identify genes that are silenced or activated by methylation. This information can be used to develop new biomarkers for early diagnosis and to identify new therapeutic targets that can be used to reverse methylation-mediated gene silencing.",[28],"2025-12-10",{"date":536,"type":33},"2025-12-18",{"date":538,"type":33},"2024-05-21",{"date":466,"type":22},{"name":541,"class":40},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":551,"briefSummary":552,"conditions":553,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":569},"100598363","phase-1-study-of-gv20-0251-in-participants-with-solid-tumor-malignancies-100598363","NCT07070518","Study of GV20-0251 in Participants With Solid Tumor Malignancies","An Open-Label Phase 1\u002F2A Study of GV20-0251 in Participants With Advanced and\u002For Refractory Solid Tumor Malignancies","Inclusion Criteria:\n\n* Before conducting any study-specific procedures, voluntarily sign an informed consent form.\n* Be able and willing to participate throughout the entire study period and comply with study procedures.\n* participants ≥18 years of age\n* Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy (Refractory or intolerant to standard therapies, must have received the standard of care therapy)\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)\n* For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression\n* ECOG performance status of 0 or 1 before C1D1\n* Part B Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment and on-treatment, if clinically feasible\n* Disease-free of active second\u002Fsecondary or prior malignancies for ≥ 2 years Laboratory test results within the required parameters\n* Women of childbearing potential (WOCBP) and men must agree to use adequate contraception\n\nExclusion Criteria:\n\n* Participants with acute leukemia or CLL\n* Participant with heart disease (NYHA ≥ Level II), myocardial infarction within the past 6 months, or unstable arrhythmia\n* Fridericia-corrected QT interval (QTcF) \\> 470 msec, or the presence of congenital long QT syndrome, or a history of clinically significant electrocardiogram (ECG) abnormalities (including pericarditis) that, in the investigator's judgment, may affect the subject's safety.\n* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy within 7 days before C1D1\n* Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy\n* Known human immunodeficiency virus (HIV) infection, known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, unless meeting the specific conditions.\n* History of major organ transplant and\u002For a bone marrow transplant\n* Symptomatic central nervous system (CNS) malignancy or metastasis\n* Serious nonmalignant disease\n* Pregnant or nursing women\n* Major surgery within 28 days prior to the first dose of study medication\n* Prior anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of GV20-0251 on Cycle 1 Day 1 (C1D1), with the exceptions.\n* History of severe allergic reactions to biologic therapy, which in the investigator's judgment may increase the subject's risk.\n* Radiation therapy for symptomatic lesions within 14 days prior to C1D1 dosing.\n* Active substance abuse\n* Any history of an immune-related ≥ Grade 3 AE attributed to prior cancer immunotherapy",{"count":550,"type":22},350,[84,25],"This is a Phase 1 and Phase 2 study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.",[28,554,555,556,557,558,459,559,273],"Adult Refractory Cancer","Endometrial Carcinoma (EC)","Squamous Head and Neck Carcinoma","pMMR\u002FMSS Adenocarcinoma of the Colon or Rectum","Non-Small Cell Lung Cancer","HCC - Hepatocellular Carcinoma","2025-12-01",{"date":562,"type":33},"2025-12-03",{"date":564,"type":33},"2025-07-11",{"date":566,"type":22},"2028-09-16",{"name":568,"class":203},"GV20 Therapeutics",3,{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":255,"enrollmentInfo":578,"targetDuration":4,"studyType":23,"phases":580,"briefSummary":581,"conditions":582,"keywords":583,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":588,"leadSponsor":590,"locationsCount":498},"100613692","phase-1-a-phase-i-study-of-wtx212a-monotherapy-or-in-combination-with-radiotherapy-in-patients-with-advanced-solid-tumors-100613692","NCT07269899","A Phase I Study of WTX212A Monotherapy or in Combination With Radiotherapy in Patients With Advanced Solid Tumors","A Phase I Study Evaluating the Preliminary Efficacy and Safety of WTX212A Injection as Monotherapy or in Combination With Radiotherapy in Patients With Advanced Solid Tumors","Reboot-107","Inclusion Criteria:\n\n1. Voluntarily signed informed consent, understanding of the study, and willingness and ability to complete all study procedures.\n2. Male or female, aged 18 to 75 years (inclusive).\n3. Patients with histologically and\u002For cytologically confirmed advanced malignant tumors.\n\nExclusion Criteria:\n\n1. Suffering from other serious internal diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, liver cirrhosis, active bleeding, etc., those with uncontrollable or severe cardiovascular diseases, such as NYHA Class II or higher congestive heart failure, unstable angina, myocardial infarction, etc., within 6 months before the first dose, difficult to control hypertension (systolic blood pressure ≥180mmHg and\u002For diastolic blood pressure ≥100mmHg).\n2. Uncontrollable pleural effusion, peritoneal effusion, or pericardial effusion requiring puncture and drainage, or recurrence requiring re-drainage after puncture and drainage.\n3. History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe lung function impairment.\n4. Previous IO drug treatment with adverse events related to the drug that required permanent discontinuation of IO treatment.",{"count":579,"type":22},12,[84],"This is a single-arm, open-label, investigator-initiated clinical study (IIT) designed to evaluate the preliminary efficacy, safety, tolerability, immunogenicity, and pharmacokinetic (PK) characteristics of WTX212A Injection in patients with advanced solid tumors.",[28,369],[28,369],"2025-11-25",{"date":586,"type":33},"2025-12-08",{"date":584,"type":33},{"date":589,"type":22},"2027-08-30",{"name":591,"class":40},"Sun Yat-sen University",{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":255,"enrollmentInfo":600,"targetDuration":4,"studyType":23,"phases":602,"briefSummary":603,"conditions":604,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":611,"locationsCount":41},"100613301","phase-2-a-single-arm-clinical-trial-using-patient-derived-tumor-tissue-fragment-models-for-drug-sensitivity-testing-to-guide-treatment-in-previously-treated-cancers-100613301","NCT07264803","A Single-arm Clinical Trial Using Patient-derived Tumor Tissue Fragment Models for Drug Sensitivity Testing to Guide Treatment in Previously Treated Cancers","A Single-arm Clinical Trial Using Patient-derived Tumor Tissue Fragment Models for Drug Sensitivity Testing to Guide Treatment in Refractory Cancers","PDTF","Inclusion Criteria\n\nPatients must meet all of the following criteria simultaneously to be eligible for enrollment. All criteria must be confirmed through clinical evaluation, laboratory tests, and imaging during the screening period, and approved in writing by the principal investigator.\n\n1. Age between 18 and 75 years (inclusive), regardless of gender.\n2. Confirmed diagnosis of refractory malignant tumors via pathological biopsy, including locally advanced unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma; confirmed as stage IV (advanced, recurrent, or metastatic) according to international TNM staging; patients with highly suspected gene mutations or requiring reconfirmation of molecular pathological diagnosis; or patients previously treated at this institution who have obtained pathological samples and completed PDTF construction but have progressed to refractory tumors.\n3. At least one measurable lesion according to RECIST v1.1 criteria; the lesion is expected to be sufficiently large (diameter greater than 2 cm), such that tissue collection does not affect pathological diagnosis or other clinical treatment needs, and residual tissue samples from pathological testing can be used to construct the PDTF model.\n4. No prior systemic treatment, or disease progression or recurrence more than 6 months after previous neoadjuvant\u002Fadjuvant chemotherapy.\n5. ECOG performance status of 0-1, ensuring the patient can tolerate biopsy and treatment.\n6. Expected survival of at least 3 months, with no severe concomitant diseases affecting trial participation.\n7. Adequate organ function, including:\n\n   * Bone marrow function: Hemoglobin ≥80 g\u002FL; Neutrophil count ≥1.5×10\\^9\u002FL; White blood cell count ≥3.5×10\\^9\u002FL; Platelet count ≥100×10\\^9\u002FL;\n   * Liver function: Serum total bilirubin ≤1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤3×ULN, or ≤5×ULN in patients with liver metastases;\n   * Renal function: Serum creatinine ≤1.5×ULN, or creatinine clearance (CrCl) ≥60 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n   * Cardiac function: New York Heart Association (NYHA) classification \\\u003C III; Left ventricular ejection fraction (LVEF) ≥50%.\n8. Women of childbearing potential must use reliable contraception or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and be willing to use appropriate contraception during the trial and for 8 weeks after the last dose of the study drug. Men must also agree to use appropriate contraception during the trial and for 8 weeks after the last dose of the study drug.\n9. Voluntary participation in the study, signed informed consent form, good compliance, and willingness to cooperate with follow-up, including providing biological samples for PDTF construction and future research.\n\nExclusion Criteria\n\nPatients meeting any of the following criteria are ineligible for enrollment. Exclusion criteria must be fully assessed during the screening period to ensure patient safety and the reliability of trial data.\n\n1. No lesions available for biopsy, or concurrent or metachronous multiple primary malignant tumors, to avoid interference with efficacy evaluation.\n2. Severe dysfunction of liver, kidney, heart, or other vital organs (e.g., Child-Pugh class C liver failure, NYHA class III-IV heart failure, creatinine clearance \\\u003C30 mL\u002Fmin).\n3. Poor compliance, or contraindications to chemotherapy, targeted drugs, or immunotherapy (e.g., history of severe allergies); allergy to any study drug or its excipients, severe allergy history, or contraindications to the study drug.\n4. Uncontrolled cardiovascular or cerebrovascular events, such as: NYHA class ≥2 heart failure; unstable angina; myocardial infarction within 1 year; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; cerebral hemorrhage or infarction (excluding asymptomatic lacunar infarcts not requiring treatment); severe cardiovascular or cerebrovascular events within 12 months; uncontrolled hypertension (systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg despite monotherapy); history of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollment, or history of bleeding tendency or bleeding within 2 months prior to enrollment, regardless of severity; stroke or transient ischemic attack within 12 months prior to enrollment.\n5. Active infection, uncontrolled hypertension, psychiatric disorders, or any condition that may affect trial safety\u002Fefficacy; severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis (patients with a history of active tuberculosis ≥1 year prior to screening should also be excluded unless there is evidence of completed appropriate treatment); interstitial lung disease, noninfectious pneumonia, pulmonary fibrosis, history of acute lung disease, or poorly controlled systemic diseases (including but not limited to diabetes, hypertension); history of active immunodeficiency or autoimmune disease, including positive HIV test, other acquired or congenital immunodeficiency diseases, organ transplantation, or autoimmune diseases.\n6. Presence of active brain metastases or leptomeningeal metastases.\n7. Clinically significant pleural effusion, pericardial effusion, or ascites requiring drainage within 2 weeks prior to the first dose of the study drug.\n8. Detectable second primary malignant tumor at enrollment, or history of other malignancies within the past 5 years (excluding adequately treated basal cell skin cancer or cervical carcinoma in situ).\n9. Any major surgery within 28 days prior to the first dose of the study drug; history of allogeneic stem cell or organ transplantation.\n10. Current gastrointestinal diseases, such as duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions judged by the investigator as potentially leading to gastrointestinal bleeding or perforation; or history of unhealed intestinal perforation or fistula after surgical treatment.\n11. Live vaccine received within 4 weeks prior to the first dose of the study drug (seasonal influenza vaccines are usually inactivated and thus allowed; intranasal vaccines are live and thus not allowed); receipt of herbal medicines or immunomodulatory drugs with anticancer indications (including thymosin, interferon, interleukin, except for local use to control ascites) within 2 weeks prior to the first dose of the study drug.\n12. Pregnant or lactating women, or women of childbearing age not using effective contraception.\n13. Current participation in other clinical trials, or recent (\\\u003C4 weeks) experimental treatment; currently participating in interventional clinical research treatment, or receipt of other investigational drugs or use of investigational devices within 4 weeks prior to the first dose of the study drug.\n14. Other factors judged by the investigator as potentially leading to early termination of the study, such as other serious diseases requiring concomitant treatment (including psychological or psychiatric disorders), significant laboratory abnormalities, or family or social factors that may affect patient safety or data and sample collection; other situations deemed unsuitable for inclusion by the investigator.",{"count":601,"type":22},35,[25],"This is a prospective, single-arm, open-label, exploratory clinical trial conducted at Qilu Hospital of Shandong University. Approximately 35 patients with advanced or metastatic refractory cancers will be enrolled. Fresh tumor or metastatic biopsy samples will be collected to establish patient-derived tumor tissue fragment models (PDTFs). Each PDTF will be validated for histologic, molecular, and genetic homology with the original tumor, followed by high-throughput ex vivo drug sensitivity testing using chemotherapy, targeted agents, or immunotherapy drugs and recommended by clinical guidelines.\n\nThis study aims to demonstrate that the PDTF platform can serve as a rapid, reliable, and clinically relevant tool for precision therapy development and clinical decision-making in refractory cancers, potentially bridging translational models and individualized clinical care.",[90,28],"2025-11-23",{"date":607,"type":33},"2025-12-04",{"date":609,"type":33},"2024-03-01",{"date":308,"type":22},{"name":612,"class":40},"Qilu Hospital of Shandong University",{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":255,"enrollmentInfo":619,"targetDuration":4,"studyType":23,"phases":621,"briefSummary":622,"conditions":623,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":4},"100612739","phase-1-safety-and-efficacy-of-combining-a-vitamin-b6-limited-diet-with-immunotherapy-in-solid-tumor-patients-a-clinical-study-protocol-100612739","NCT07257497","Safety and Efficacy of Combining a Vitamin B6-Limited Diet With Immunotherapy in Solid Tumor Patients: A Clinical Study Protocol","Inclusion Criteria:\n\n* (1) Sign a written informed consent form before any study - related procedures are carried out.\n\n  (2) Males or females, aged 18 - 80 years old. (3) Diagnosed with solid tumors by pathological tissue biopsy. (4) According to the RECIST v1.1 (Response Evaluation Criteria in Solid Tumors Version 1.1) criteria, there is at least 1 measurable lesion (lesions previously treated with local therapies such as radiotherapy cannot be regarded as measurable lesions).\n\n  (5) ECOG (Eastern Cooperative Oncology Group Performance Status) score of 0 - 1.\n\n  (6) NRS - 2002 (Nutritional Risk Screening 2002) score \\\u003C 3. (7) BMI (Body Mass Index) ≥ 18.5 (can be adjusted appropriately according to the actual situation).\n\n  (8) Patients who can eat orally or through a feeding tube and can tolerate enteral nutrition.\n\n  (9) Sufficient organ function, and the subjects need to meet the following laboratory indicators: In the absence of granulocyte - colony - stimulating factor use in the past 14 days, the absolute neutrophil count ≥ 1.5×10⁹\u002FL.\n\nPlatelets ≥ 75×10⁹\u002FL. In the absence of blood transfusion or erythropoietin use in the past 7 days, hemoglobin ≥ 8 g\u002FdL.\n\nSerum albumin ≥ 3.0 g\u002FdL. Total bilirubin ≤ 1.5× the upper limit of normal (ULN). Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5×ULN. In case of liver metastasis, ALT and\u002For AST ≤ 5×ULN, and total bilirubin ≤ 3×ULN. In case of liver or bone metastasis, Alkaline Phosphatase (AKP) ≤ 5×ULN.\n\nCreatinine clearance rate ≥ 50 mL\u002Fmin (calculated according to the Cockcroft - Gault formula) or serum creatinine ≤ 1.5×ULN.\n\nInternational Normalized Ratio (INR) ≤ 1.5×ULN, Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN.\n\nUrine protein \\\u003C 2+ (if urine protein ≥ 2+, a 24 - hour urine protein quantification can be performed, and subjects with a 24 - hour urine protein quantification \\\u003C 2.0 g can be enrolled).\n\n(10) Women of child - bearing potential must agree to avoid sexual intercourse (heterosexual intercourse) or use a reliable and effective contraceptive method from the signing of the informed consent form until at least 6 months after the last administration of the study drug. In addition, the serum HCG (Human Chorionic Gonadotropin) test must be negative within 3 days before the start of the study treatment, and the subject must be non - lactating. A female patient is considered to be of child - bearing potential if she is post - menopausal but has not reached the post - menopausal state (non - menstrual period ≥ 12 consecutive months, and no other causes are found except menopause) and has not undergone sterilization surgery (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).\n\n(11) If there is a risk of pregnancy, all subjects (regardless of male or female) need to use a contraceptive method with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of the chemotherapy drug).\n\nExclusion Criteria:\n\n* (1) Patients with cognitive impairment or mental illness who are unable to understand the study content.\n\n  (2) Patients with central nervous system or meningeal metastases. (3) Patients with clinically symptomatic moderate or severe ascites (that is, those who require therapeutic paracentesis within 2 weeks before the start of study treatment; patients with only a small amount of ascites shown on imaging and no clinical symptoms can be enrolled).\n\n  (4) Patients with uncontrolled or moderate to severe pleural effusion and pericardial effusion.\n\n  (5) Patients with severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic and mechanical intestinal obstruction; tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula, or abdominal abscess; patients with extra - gastrointestinal bleeding with a CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or above within 6 months before the start of study treatment or grade 2 or above within 3 months (such as abnormal vaginal bleeding, hematemesis).\n\n  (6) Patients known to be allergic to the active ingredients or excipients of the study drug.\n\n  (7) Patients with poorly controlled diabetes. (8) Patients with poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg under routine antihypertensive treatment), with a history of hypertensive crisis or hypertensive encephalopathy.\n\n  (9) Patients with severe cardiovascular and cerebrovascular diseases, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, and major vascular diseases within 6 months before enrollment (including but not limited to aortic aneurysms requiring surgical repair or recent arterial thrombosis); patients with poorly controlled clinical symptoms or heart diseases, such as unstable angina pectoris, NYHA (New York Heart Association) heart failure grade II or above, left ventricular ejection fraction \\\u003C 50% on color Doppler echocardiography, or severe arrhythmias that cannot be controlled by drug treatment.\n\n  (10) Pregnant or lactating women. (11) Other situations considered by the investigator as inappropriate for enrollment.",{"count":620,"type":22},20,[84],"This is a phase I single-arm clinical study conducted by West China Hospital of Sichuan University. The research duration is from October 2025 to June 2027, aiming to evaluate the safety and efficacy of vitamin B6-restricted (-VitB6 diet) in patients with solid tumors. A total of 20 patients with solid tumors, aged 18 - 75 years old, who meet specific inclusion criteria such as having at least one measurable lesion according to RECIST v1.1 criteria and an ECOG score of 0 - 1, will be enrolled.\n\nPatients will receive -VitB6 diet intervention for 2 cycles (3 weeks per cycle) while continuing their original immunotherapy. The -VitB6 diet strictly limits vitamin B6 intake, and patients can only consume foods with extremely low vitamin B6 content. The research will collect data on patients' basic information, nutritional status, blood, immunity, and tumor imaging at baseline and during follow - up.\n\nThe primary endpoint of the study is the occurrence type, frequency, and severity of treatment-related adverse events (TEAE). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), and duration of response (DoR). Exploratory endpoints involve evaluating the nutritional adequacy of the -VitB6 diet, its impact on patients' quality of life, and its influence on amino acid metabolism and immune status in patients.\n\nDuring the study, safety will be evaluated by closely monitoring adverse events according to NCI CTCAE (version 5.0), and efficacy will be assessed using RECIST 1.1 standard. Statistical analysis will be performed using SAS 9.4 software, including descriptive statistics for safety and efficacy data, and calculating confidence intervals for relevant indicators. This study hopes to provide new strategies and directions for the treatment of advanced solid tumors.",[28],"2025-11-20",{"date":626,"type":33},"2025-12-02",{"date":628,"type":22},"2025-12-09",{"date":630,"type":22},"2027-06-01",{"name":310,"class":40},{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":255,"enrollmentInfo":639,"targetDuration":4,"studyType":23,"phases":641,"briefSummary":642,"conditions":643,"keywords":645,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":569},"100581314","phase-1-a-phase-ibii-clinical-study-to-evaluate-hlx43-in-combination-with-serplulimab-in-patients-with-advancedmetastatic-solid-tumors-100581314","NCT06848699","A Phase Ib\u002FII Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced\u002FMetastatic Solid Tumors","A Phase Ib\u002F II Clinical Study to Evaluate the Safety ,Torlerbility , and Efficacy of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab (Anti-PD-1 Humanized Monocl ) in Patients With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily participate in the clinical trial; fully understand and be informed about this study and sign the Informed Consent Form (ICF); be willing and able to comply with and complete all trial procedures;\n2. Age at the time of signing the ICF is ≥ 18 years and ≤ 75 years;\n3. Phase Ib enrollment of patients with histologically or cytologically confirmed advanced \u002Fmetastatic solid tumor who have experienced treatment failure or for whom no standard treatment is available;Phase II enrollment includes advanced \u002Fmetastatic NSCLC subjects confirmed by histology or cytology, requiring the presence of EGFR mutation and failure or intolerance to EGFR-TKI or\u002Fand platinum-based chemotherapy.\n4. Within 4 weeks prior to the first dose, at least one measurable lesion assessed by the investigator according to RECIST 1.1;\n5. Subjects must provide qualified tumor tissue samples for the determination of PD-L1 expression levels.\n6. The ECOG PS score within 7 days prior to the first use of the Investigational Product is 0 or 1;\n7. Expected survival ≥ 12 weeks;\n8. Major organ functions are normal, meeting the following criteria (within 14 days prior to the first administration in this study, no transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) treatment was received):\n9. Female subjects of childbearing potential must meet the following criteria:\n\n   a)The blood pregnancy test must be negative within 7 days prior to the first administration of the medication; b)Agree to use at least one highly effective method of contraception during the trial period and for at least 6 months after the last administration of the drug;c)Breastfeeding is contraindicated.\n10. Male subjects must meet the following criteria: agree to use at least one highly effective method of contraception during the trial and for at least 6 months after the last dose.\n\nExclusion Criteria:\n\n1. History of any second malignancy within 3 years prior to randomization, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.\n2. Previously experienced ≥ Grade 3 immune-related Adverse Events during immunotherapy.\n3. Pleural effusion or pericardial effusion, or ascites requiring clinical intervention as determined by the investigator;\n4. Subjects with clinical symptoms of brain metastases, spinal cord compression, meningitis carcinomatosa, or other evidence indicating that brain or spinal cord metastatic lesions are not yet controlled; Note: Subjects with asymptomatic or stable brain metastases, spinal cord compression, or meningitis carcinomatosa as determined by theinvestigator may be eligible for enrollment;\n5. Subjects with a history or current condition of interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe impairment of pulmonary function, as determined by the sub investigator, that may interfere with the detection and management of suspected drug-related pulmonary toxicity;\n6. The subject has poorly controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or higher heart failure or left ventricular ejection fraction (LVEF) \\\u003C50%; (2) unstable angina; (3) myocardial infarction or cerebrovascular accident within the past 6 months (excluding lacunar infarction, minor cerebral ischaemia, or transient ischaemic attack); (4) uncontrolled arrhythmia (including QTc interval ≥450 ms for males and ≥470 ms for females, with QTc interval calculated using the Fridericia formula); (5) poorly controlled hypertension (systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>100 mmHg despite active treatment);\n7. History of immunodeficiency diseases, including testing positive for human immunodeficiency virus (HIV), or having other acquired or congenital immunodeficiency diseases, or a history of organ transplant;\n8. Has active pulmonary tuberculosis;\n9. Subjests with active HBV, HCV infection or co-infection;\n10. There is a known active or suspected autoimmune disease. Enrollment is allowed for subjects in a stable condition who do not require systemic immunosuppressive therapy.\n11. Subjects requiring systemic corticosteroids (\\>10 mg\u002Fday prednisone therapeutic dosage) or other immunosuppressive drug therapy within 14 days prior to the first administration of the Investigational Product or during the study. However, the following situations allow for enrollment: in the absence of active autoimmune disorders, the use of topical external application or inhaled steroids and adrenal hormone replacement therapy at a dosage ≤10 mg\u002Fday prednisone therapeutic dosage is permitted; prophylactic medication is allowed.\n12. Any active infection requiring systemic anti-infective therapy within 14 days prior to the first administration of the Investigational Product;\n13. Within 28 days prior to the first administration of the Investigational Product, the subject has undergone major surgery. In this study, major surgery is defined as a procedure requiring at least 3 weeks of postoperative recovery before being eligible to receive treatment in this study. Tumor paracentesis or lymph node incisional biopsy is permitted for enrollment.\n14. Strong inhibitors or strong inducers of CYP2D6 or CYP3A were used within 2 weeks prior to the first administration of the drug.\n15. Received live viral vaccine treatment within 28 days prior to the first administration of the Investigational Product; however, inactivated viral vaccines for seasonal flu and novel coronavirus are permitted;\n16. Participating in another clinical trial or planning to start this study with less than 14 days since the end-of-therapy of the previous clinical trial; less than 5 half-lives since the last course of anti-tumor therapy;\n17. Known to have a severe allergy to any monoclonal antibody;\n18. Subjects who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.",{"count":640,"type":22},105,[84,25],"The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced\u002Fmetastatic solid tumors",[28,644],"Non Small Cell Lung Cancer",[646],"HLX43","2025-11-14",{"date":649,"type":33},"2025-11-17",{"date":651,"type":33},"2025-02-25",{"date":653,"type":22},"2027-10-01",{"name":655,"class":203},"Shanghai Henlius Biotech",{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":4,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":663,"targetDuration":4,"studyType":23,"phases":664,"briefSummary":665,"conditions":666,"keywords":667,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":498},"100601973","a-study-of-a-distress-screening-and-referral-program-in-people-with-recently-diagnosed-cancer-100601973","NCT07117461","A Study of a Distress Screening and Referral Program in People With Recently Diagnosed Cancer","A Pilot Distress Screening and Referral Program to Detect Comorbid Psychosocial Distress in NYC Safety Net Hospitals Serving Diverse and Underserved Patients Diagnosed With Cancer","Inclusion Criteria:\n\n* New solid tumor cancer diagnosis (per EMR)\n* Treated or will be treated at Jamaica Hospital Medical Center (per EMR)\n* Has a NCCN DT score of 0 through 10 (per EMR)\n* Age ≥ 18 years (per EMR or self-report)\n* English- or Spanish preferred language for healthcare (per self-report)\n* Able to provide consent (per completion of consent)\n\nExclusion Criteria:\n\n* In the provider or investigative teams' judgement, cognitively not intact to participate in the study (per EMR or investigative team)",{"count":507,"type":22},[52],"It is recommended that cancer centers screen patients for distress and refer them to mental health services when their distress levels reach a certain level. However, many cancer centers don't have distress screening and referral programs. This study will provide valuable information about one distress screening and referral program and whether it can be helpful for a large and diverse group of cancer patients that includes both English- and Spanish-speaking patients.",[28],[28,668,669],"24-296","Memorial Sloan Kettering Cancer Center","2025-10-14",{"date":672,"type":33},"2025-10-16",{"date":674,"type":33},"2025-07-22",{"date":676,"type":22},"2026-07-22",{"name":669,"class":40},{"id":679,"slug":680,"hasResults":12,"nctId":681,"briefTitle":682,"officialTitle":682,"acronym":4,"eligibilityCriteria":683,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":684,"enrollmentInfo":685,"targetDuration":4,"studyType":23,"phases":686,"briefSummary":687,"conditions":688,"keywords":689,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":692,"lastUpdatePostDateStruct":693,"startDateStruct":695,"completionDateStruct":697,"leadSponsor":698,"locationsCount":41},"100604219","phase-1-exploratory-study-of-super-dc-cell-injection-in-preventing-recurrence-after-radical-surgery-for-tumors-100604219","NCT07146672","Exploratory Study of Super DC Cell Injection in Preventing Recurrence After Radical Surgery for Tumors","Inclusion Criteria:\n\n* Age 18-80 years old, weight ≥ 40kg; No gender limit；\n* Subjects with malignant solid tumors diagnosed by histology or cytology and undergoing radical resection surger；\n* At the beginning of the study (after surgery), there were no lesions, no local recurrence or distant metastasis on the imaging, and no brain metastasis (images within one month before enrollment can be used for screening)；\n* Subjects in the safety verification stage need to provide immunohistochemical test results with positive expression of Survivin or P53 or MUC1;\n* ECOG score 0-1 points;\n* There are sufficient venous channels and no contraindications for peripheral blood mononuclear cell collection surgery;\n* Organs and bone marrow function well:\n* a:Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% evaluated by echocardiography within one month of enrollment; The electrocardiogram is basically normal;\n* b:Platelets ≥ 90 × 10 \\^ 9\u002FL;\n* c:Hemoglobin ≥ 90g\u002FL (no blood transfusion or erythropoietin dependence within 7 days);\n* d:Total bilirubin ≤ 2 times the upper limit of normal value;\n* e:Serum creatinine ≤ 1.5 times the upper limit of normal value;\n* f:Transaminases (AST, ALT) ≤ 2.5 times the upper limit of normal value (if liver cancer is 5 times the upper limit of normal value);\n* g:International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the upper limit of normal value;\n* Able to understand trial requirements and matters, willing to participate in clinical research according to trial requirements\n\nExclusion Criteria:\n\n* Positive for HIV antibodies or syphilis antibodies; positive for hepatitis B surface antigen, and positive for hepatitis B core antibody or e antibody with viral DNA copy number above the detection limit or ≥1000 copies\u002Fml; or hepatitis C virus RNA copy number above the detection limit.\n* Any uncontrollable active infection, coagulation disorder, or any other major disease;\n* Pregnant or lactating women;\n* Suffering from active neuroautoimmune or inflammatory diseases, such as any of the following: inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, multiple sclerosis, Sjogren's syndrome, etc., and receiving relevant treatment; Subjects who are still using immunosuppressants for organ transplantation; Or subjects who have been using immunosuppressive drugs such as glucocorticoids for a long time cannot stop at least 4 weeks before enrollment; Severe allergic constitution;\n* Subjects with existing abnormalities in the central nervous system, such as seizures, cerebral vascular ischemia\u002Fbleeding, dementia, cerebellar diseases, or any autoimmune diseases associated with central nervous system involvement;\n* Major cardiovascular diseases with clinical significance include:","80 Years",{"count":579,"type":22},[84,25],"The study is a controlled, open-label exploratory clinical trial.",[28],[690,691],"Vaccines","Immunologic Factors","2025-08-21",{"date":694,"type":33},"2025-08-28",{"date":696,"type":33},"2025-07-31",{"date":466,"type":22},{"name":699,"class":203},"Shanghai Cell Therapy Group Co.,Ltd"]