[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-tumor-phase-1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-tumor-phase-1":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,68,92,114,144],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100605500","phase-1-ep102-safety-and-efficacy-in-mettl3-modulation-in-advanced-solid-tumors-100605500",false,"NCT07163325","EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors","A Phase 1 Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered EP102 Monotherapy in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants must have a histological diagnosis of locally advanced or metastatic malignant solid tumors of one of the following cancer types:\n\n  * ovarian cancer\n  * cervical cancer\n  * endometrial cancer\n  * testicular cancer\n  * cholangiocarcinoma\n  * thyroid cancer\n  * parathyroid cancer\n  * adrenal cancer\n  * pancreatic cancer\n  * non-small-cell lung cancer (NSCLC)\n  * head-and neck cancer\n  * renal cell cancer\n  * urethral cancer\n  * bladder cancer\n  * colorectal cancer\n  * gastric cancer\n  * esophageal cancer\n  * triple-negative breast cancer\n  * thymoma\n  * soft tissue sarcoma\n* Participants must have failed (i.e. progressed on, or been intolerant to standard treatment), or no standard treatment must exist, or they must have refused standard treatment. All participants must have received at least one prior line of systemic therapy.\n* Participants must have at least one measurable lesion per RECIST v1.1.\n* Participant must have a life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n* Participants with an active severe infection or unexplained fever \\> 38.5°C during screening or on the first day of study drug administration are excluded. However, at the Investigator's discretion, participants with tumor-related fever may be enrolled.\n* Participants with known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection (hepatitis B surface antigen (HBsAg) positive in serum), or active hepatitis C virus (HCV) infection (HCV RNA positive in serum).\n* Participants with known dysphagia, short-bowel syndrome, gastroparesis, or any condition that may impair the ingestion or gastrointestinal absorption of orally administered drugs.\n* Pregnant or breastfeeding participants.\n* Participants who have received IMP or devices in other clinical trials within four weeks before the first dose.\n* Participants with prior exposure to selective METTL3 inhibitor therapy.","ALL","18 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This the first-in-human (FIH) study for the Investigational Medicinal Product (IMP) EP102, is designed to explore the maximum tolerated dose (MTD), the overall safety profile, its pharmacokinetic (PK) \u002F pharmacodynamic (PD) profile, and an exploratory evaluation of antitumor activity in participants with advanced solid tumors, who have no available standard therapy or who have failed standard therapies.\n\nThis study will inform on recommended doses for further studies, e.g. dose optimization studies and \u002F or efficacy and safety studies.",[26],"Advanced Solid Tumor (Phase 1)",[28,29],"Advanced Solid Tumors","EP102","RECRUITING","2026-06-10",{"date":33,"type":34},"2026-06-11","ACTUAL",{"date":36,"type":34},"2025-07-24",{"date":38,"type":20},"2028-11",{"name":40,"class":41},"Epics Therapeutics","INDUSTRY",11,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100643536","phase-1-an-initial-evaluation-of-an8025-in-solid-tumors-100643536","NCT07639047","An Initial Evaluation of AN8025 in Solid Tumors","Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of AN8025 in Participants With Unresectable Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Aged ≥18 years old.\n2. Able to provide informed consent obtained before any study-related activities and according to local guidelines.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n4. Have an estimated life expectancy ≥ 12 weeks, in the judgment of the investigator.\n5. Have histological or cytological evidence of a diagnosis of cancer that is advanced and\u002For metastatic with progression after treatment with available standard therapies or are intolerant to or refuse standard therapies that are known to provide clinical benefit.\n6. Part A Dose Escalation only: Participants have unresectable advanced or metastatic solid tumors, with no preference of cancer type.\n7. Part B Dose Expansion only: Participants enrolled into tumor-specific cohorts have unresectable advanced metastatic disease. Participants must also have progressed after treatment with the appropriate targeted therapy. Participants must be primary refractory or non-responding to anti-PD-1 monotherapy as defined by:\n\n   1. The participant has received at least 2 doses of an approved anti-PD-1\u002FPD-L1 monoclonal antibody\n   2. The participant has demonstrated progressive disease (PD) after anti-PD-1\u002FPD-L1 therapy as defined by RECIST Version 1.1, which was subsequently confirmed by a second assessment no less than 4 weeks from the date of the first documented PD to rule out pseudo-progression.\n   3. Participants who have received anti-PD-1\u002FPD-L1 therapy as part of their adjuvant therapy but experienced recurrence with locally advanced or metastatic disease within 6 months after completing adjuvant therapy may be eligible for Part B.\n8. Part B Dose Expansion only: Participants enrolled into the expansion cohort must have documented PD-L1 tumor expression on ≥1% tumor cells (i.e. TPS or TC ≥1%) as assessed by validated immunohistochemistry (IHC) assay on archival or fresh tumor tissue.\n9. Participants have consented to provide archival tumor tissue collected within 5 years or a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Archival tumor tissue can be formalin-fixed, paraffin embedded (FFPE) tissue blocks or at least 15 freshly-sectioned slides. Tissue should be obtained from surgical resection or core needle biopsy. Fine-needle aspiration (FNA), pleural effusion, or ascitic fluid samples are not acceptable. FFPE blocks are preferred to slides and newly obtained biopsies are preferred to archival tissue. For participants who have consented to provide newly obtained fresh biopsy of baseline tumor tissue, the biopsy is required to be collected during the screening period. Tissue requirements may be waived on a case-by-case basis after discussion with the sponsor if tissue or biopsy is not available or feasible.\n10. Have at least one measurable lesion as defined per RECIST v1.1. Bone metastases are not considered measurable. Participants who only have non-measurable lesion(s) may be eligible for Part A, except for \"back-filled\" cohorts.\n11. Have adequate hematologic function and major organ function, defined by laboratory assessment documented within 7 days prior to first dose of study treatment:\n\n    1. Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL.\n    2. Hemoglobin ≥ 9 g\u002FdL (which may be reached by transfusion).\n    3. Platelets ≥ 100 x 109\u002FL (which may be reached by transfusion).\n    4. International normalized ratio (INR) ≤ 1.5.\n    5. Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if liver metastases are present.\n    6. Total bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN if Gilbert's syndrome is present.\n    7. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCL) \\> 50 mL\u002Fmin.\n    8. Thyroid stimulating hormone (TSH) within normal limits. If TSH is not within normal limits at baseline, the participant will still be eligible if total T3 or free T3 (FT3) and free T4 (FT4) are within the normal limits.\n12. Have discontinued previous cancer treatment and recovered from the acute toxicity of therapy. Participants must have discontinued from previous treatment with length of time prior to first dose of study treatment.\n13. Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study treatment administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of the study treatment.\n\nExclusion Criteria:\n\n1. Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.\n2. Have a serious concomitant systemic disorder that, in the judgment of the investigator, would compromise the participant's ability to adhere to the protocol.\n3. Known human immunodeficiency virus (HIV) infection per HIV 1 and\u002For 2 antibodies.\n4. Participants with evidence of Hepatitis B or Hepatitis C infections (positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody) must fulfill the following criteria in order to be eligible for the study:\n\n   1. Hepatitis B virus (HBV) viral load ≤2500 copies or ≤500 IU\u002FmL before study enrollment, and participants with active HBV need to be on anti-HBV suppression ≥3 months, throughout treatment and for 6 months after; and\n   2. Hepatitis C virus (HCV) viral load ≤lower limits of detection, participants with curable or controllable HCV infection are eligible. Participants with detectable HCV RNA can remain on continuous, effective antiviral therapy during the study.\n\n   Note: The necessity of conducting HBV DNA\u002FHCV RNA quantitative testing is based on the local epidemiology and local clinical practice.\n5. Active tuberculosis.\n6. Active infection requiring intravenous therapy.\n7. Prior or second concurrent primary malignancies that, in the judgment of the investigator, may affect the interpretation of results. Participants with carcinoma in situ of any origin and participants with prior malignancies who are in remission and whose likelihood of recurrence is very low (such as basal cell carcinoma), as judged by the investigator, are eligible for this study.\n8. Have an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. This criterion does not apply to participants with:\n\n   1. Resolved childhood asthma\u002Fatopy or who require intermittent use of bronchodilators or corticosteroid;\n   2. Raynaud's syndrome; or\n   3. Sjogren's syndrome. Use of topical, ophthalmic, inhaled, and intranasal corticosteroids are permitted.\n9. Evidence of (a) interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity (for example, interstitial lung disease); (b) active, noninfectious pneumonitis; or (c) history of noninfectious pneumonitis that required corticosteroid therapy or immune related pneumonitis.\n10. Moderate or severe cardiovascular disease, including:\n\n    1. A myocardial infarction or any other arterial thrombotic event including cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment;\n    2. Unstable angina pectoris;\n    3. New York Heart Association Class III\u002FIV congestive heart failure;\n    4. Aneurysm of major vessels or heart;\n    5. Left ventricular ejection fraction \\\u003C50% (evaluation based on institutional lower limit of normal);\n    6. Uncontrolled hypertension;\n    7. Severe, moderate, or clinically significant valvulopathy;\n    8. Documented major ECG abnormalities that, in the judgment of the investigator, are clinically significant (for example, arrhythmia requiring treatment)\n    9. Mean QTc ≥470 ms calculated using Fridericia's correction and confirmed by triplicate ECG.\n11. History of Grade ≥ 3 immune related Adverse Events (irAE) related to prior immune checkpoint inhibitor therapy or any active or unresolved AE from prior anti-cancer therapy that has not resolved to ≤ Grade 1 or baseline (except controlled endocrinopathies). Participants with a history of Grade ≥3 irAEs attributed to prior anti-CTLA4 (e.g. ipilimumab) combined with anti-PD(L)1 (e.g. pembrolizumab, nivolumab, atezolizumab) are eligible for enrollment if the irAE occurred during combination therapy, and they subsequently tolerated anti-PD(L)1 monotherapy without recurrence of Grade ≥3 irAEs.\n12. Participants permanently discontinued due to any immune-related toxicity requiring prolonged (≥10 weeks) high-dose corticosteroids (≥20 mg\u002Fday prednisone equivalent) or other immunosuppressants (e.g., infliximab, mycophenolate, cyclophosphamide) will be excluded.\n13. Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Participants with treated CNS metastases are eligible for this study if they are not requiring concurrent treatment, including but not limited to surgery, radiation, corticosteroids and\u002For anticonvulsants to treat CNS metastases, and their disease is asymptomatic and radiographically stable for at least 30 days.\n14. Have received a live vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (for example, FluMist®) are live attenuated vaccines and are not allowed.\n15. Are pregnant or planning to become pregnant during the study or within 6 months following the last dose of AN8025. Plan to be breastfeeding from C1D1 of study or within 6 months following the last dose of AN8025.\n16. Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n17. Use of other herbal supplements, traditional medicines, or prescription medications that are known or suspected to interact with the investigational product or effect disease treatment\u002Fside effect management, as determined by the study investigator",{"count":51,"type":20},91,[23],"The goal of this clinical trial is to determine the appropriate dose of AN8025 for use in the treatment of advanced solid tumors. This study will be conducted in in adults \\>18 years of age. The main questions to answer:\n\n1. Determine which dose level of AN8025 is safe and tolerability in participants with advanced solid tumors\n2. To determine the maximum tolerated of AN8025 for future testing.\n\nParticipants will visit their study site in 3 week cycles, during which they will be under go treatment with AN8025 and visit their clinical site during each cycle for check ups and testing.",[26],[56,57,58],"Advance Solid tumors","Tri-specific","PD-L1","2026-06-05",{"date":31,"type":34},{"date":62,"type":34},"2025-11-01",{"date":64,"type":20},"2028-01",{"name":66,"class":41},"Adlai Nortye Biopharma Co., Ltd.",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":67},"100639077","phase-1-a-phase-i-study-of-jlm019-injection-100639077","NCT07623850","A Phase I Study of JLM019 Injection","A Phase I Study to Evaluate the Safety and Tolerability of JLM019 Injection in Patients With Advanced Malignancies","JLM019","Inclusion Criteria:\n\n1. Eighteen years of age or older;\n2. Patients with histopathologically or cytologically confirmed advanced solid tumors (AST) or relapsed\u002Frefractory (r\u002Fr) Hodgkin's\u002FNon-Hodgkin's lymphomas (HL\u002FNHL, including transformed lymphomas):\n\n   * AST subtypes include but are not limited: colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), non-small cell lung cancer (NSCLC), gastric cancer (GC), ovarian cancer (OV), renal cell carcinoma (RCC), melanoma, biliary tract cancer (BTC), alveolar soft part sarcoma (ASPS), etc.\n   * HL\u002FNHL subtypes include but are not limited: classical Hodgkin lymphoma (cHL), diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), mantle cell lymphoma (MCL), etc.\n3. Measurable disease as defined as:\n\n   * AST: At least one tumor lesion ≥ 10 mm in the longest diameter as assessed by computed tomography (CT);\n   * HL\u002FNHL: Fluorodeoxyglucose (FDG) avid disease by positron emission tomography (PET) and ≥ 1 lesion \\> 15 mm in the longest diameter by \\> 10 mm in the short axis, as assessed by CT;\n4. Patients with the following molecular profiles will be prioritized for enrollment:\n\n   * High tumor T-cell infiltration (e.g., elevated T-cell GEP score);\n   * TMB \\> 10 mut\u002FMb、MSI-H\u002FdMMR status or POLE\u002FPOLD1 mutations. Absence of β2M and JAK1\u002FJAK2 loss-of-function mutations.\n5. Submission of tumor biopsy representative of the current disease, which may consist of any of the following:\n\n   * Archived formalin-fixed paraffin-embedded (FFPE) tissue block;\n   * At least 15-20 slides of tumor tissue from an FFPE block suitable for immunohistochemistry (IHC), including ≥ 10 % tumor content per section with ≥ 20 mm2 of evaluable tissue which may include ≤ 50 % tumor adjacent tissue;\n   * A fresh tumor biopsy obtained by surgical excision or core needle procedure prior to the first dose of JLM019 Injection;\n6. For patients with accessible tumors, willingness to undergo on-study biopsy as scheduled in the protocol;\n7. Eastern Cooperative Oncology Group (ECOG) performance status grade 0\\~1;\n8. Life expectancy ≥ 3 months estimated by the Investigator;\n9. Recovery to Grade ≤ 1 for any non-laboratory toxicity resulting from previous anticancer therapy prior to the first dose of investigational product (except alopecia, hearing loss, Grade ≤ 2 neuropathy, or endocrinopathy managed with replacement therapy);\n10. Adequate baseline hematologic, renal, hepatic, and cardiac function as defined by:\n\n    * Lymphocyte ≥ 0.5 × 109\u002FL；\n    * ANC ≥ 1.5 × 109\u002FL;\n    * Platelet count (PLT) ≥ 100 × 109\u002FL;\n    * Hemoglobin (HGB)≥ 90 g\u002FL (no packed red blood cell transfusion within the prior 2 weeks);\n    * Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for patients with Gilbert's disease;\n    * Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73 m2, as calculated by the Modification of Diet in Renal Disease (MDRD) formula;\n    * ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN if there is evidence of hepatic involvement by malignant disease);\n    * International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless the patient is receiving anticoagulant therapy in which PT or aPTT is within therapeutic range of intended use of anticoagulants;\n    * High sensitivity cardiac troponin I (hs-cTnI) and N-terminal pro B-type natriuretic peptide (NT-proBNP) ≤ ULN (asymptomatic abnormalities may be permitted after clearance by cardiology consultation).\n11. All patients and their partners must have no plans for conception from screening period and during the trial, and agree to practice effective contraception during the trial and for 4 months after the last dose of JLM019.\n12. Able to participate and willing to give written informed consent form.\n\nExclusion Criteria:\n\n1. Allergy to JLM019 Injection components;\n2. History of Grade 4 infusion-related, anaphylactic or allergic reaction to any previous monoclonal antibody or other Fc-based protein therapy;\n3. Experienced any cardiovascular immune-related adverse event (irAE), or discontinued from that treatment due to a Grade 3 or higher irAE in previous ICI therapy;\n4. Any serious or uncontrolled health conditions listed below:\n\n   * Patients with concurrent infections requiring intravenous antimicrobial therapy within the past 2 weeks, or with unexplained fever (body temperature ≥ 37.5 °C);\n   * History of vascular diseases within the past 6 months (including myocardial infarction, unstable angina, cerebrovascular diseases, and peripheral arterial or aortic diseases);\n   * Uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on at least two separate occasions after antihypertensive treatment);\n   * Individuals with active thrombosis, active bleeding, or pathological conditions associated with high bleeding risk (such as coagulation disorders);\n   * Has an active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment;\n   * Any serious or uncontrolled cardiovascular condition, including but not necessarily limited to:\n\n     1. Any history of myocarditis of any etiology;\n     2. History of New York Heart Association Class III or IV congestive heart failure, myocardial infarction, unstable angina, cerebrovascular accident, cardiac hospitalization, or other acute uncontrolled heart disease within 6 months of scheduled C1D1;\n     3. Left ventricular ejection fraction \\\u003C 45 % on screening echocardiogram;\n     4. Any clinically significant findings on screening EKG such as atrial or ventricular arrythmia (other than sinus tachycardia) or AV conduction abnormality such as left bundle branch block (such patients may be enrolled after cardiology clearance and Sponsor approval);\n5. History of (non-infectious) pneumonitis \u002F interstitial lung disease or current pneumonitis \u002F interstitial lung disease;\n6. Presence of any active central nervous system (CNS; brain or leptomeningeal) metastases. Solid tumor patients with CNS metastases are eligible if previously treated and there is no magnetic resonance imaging (MRI) evidence of progression for ≥ 8 weeks after treatment is complete and within 28 days prior to first dose of JLM019 Injection;\n7. Prior organ allograft or allogeneic hematopoietic stem cell transplantation (HSCT). Lymphoma patients ≥ 3 months post-HSCT with no evidence of active graft versus host disease may be eligible upon approval by the Investigator or Sponsor;\n8. Receipt of any of the following within the timeframes indicated, before first scheduled dose of JLM019 Injection:\n\n   1. Checkpoint inhibitors, including PD-(L)1 (e.g., pembrolizumab, nivolumab, cemiplimab, avelumab, durvalumab), CTLA-4 (e.g., ipilimumab, tremelimumab) and Lag-3 (e.g., relatlimab), or costimulatory agonists (including but not limited to CD28, CD134 (OX40), CD137 (4-1BB)): 3 months (135 days for atezolizumab);\n   2. Chemotherapy, small molecule anticancer agents (e.g., kinase inhibitors), or radiation: 2 weeks. Note: for lung cancers or mesotheliomas, radiation therapy to the lung that is \\> 30 Gy within 6 months;\n   3. Other monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, antibody-like drugs, cytokines, cell therapies, or radio immunoconjugates: 4 weeks (2 weeks permissible with documented disease progression and approval by the medical monitor or Sponsor);\n9. Currently participating in another clinical trial or has participated in another clinical trial within 4 weeks prior to the first dose of the investigational study treatment. Note: Patients who have entered the follow-up phase of another study may be enrolled if at least 4 weeks have elapsed since their last dose of study treatment;\n10. Any condition requiring systemic treatment with either corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medications within 14 days of the first dose of JLM019 Injection. Inhaled, intranasal or topical corticosteroids or adrenal replacement doses of corticosteroids are permitted in the absence of active autoimmune disease;\n11. Received a live or live-attenuated vaccine within 30 days prior to the first dose of JLM019 Injection. Note: Administration of inactivated vaccines is allowed;\n12. Received radiotherapy within 2 weeks of start of study treatment or had a history of radiation pneumonitis. Note: Patients must have recovered from all radiation-related toxicities, not required corticosteroids, and show no evidence of radiation pneumonitis. A 1-week washout period is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease;\n13. Any second malignancy active within the previous 3 years( (except adequately treated carcinoma in situ of cervix, basal cell carcinoma or squamous cell skin carcinoma));\n14. Patients with a history of AIDS, syphilis, or active hepatitis \\[For hepatitis B: positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV-DNA copy number above the upper limit of quantification; for hepatitis C: positive HCV antibody and HCV RNA copy number above the upper limit of quantification\\].\n15. Pregnancy or lactation, and a woman of childbearing potential (WOCBP) who has a positive pregnancy test (within 7 days) prior to treatment;\n16. Patients deemed unsuitable for participation in this study at the Investigator's discretion.",{"count":77,"type":20},115,[23],"This is a multicenter, single-arm, open-label, dose escalation phase (Part A) and dose expansion (Part B) study to evaluate the safety and tolerability of JLM019 Injection in patients with advanced malignancies.\n\nThe study subjects are adults with advanced malignancies including advanced solid tumors or relapsed\u002Frefractory lymphoma.\n\nDuring the dose escalation phase, the dose escalation scheme is the accelerated titration in 0.001 - 0.2 mg\u002Fkg cohorts plus a traditional '3 + 3' design in 0.6 - 10 mg\u002Fkg cohorts, jointly in nine dose cohorts 0.001, 0.01, 0.05, 0.2, 0.6, 1.5, 3, 6 and 10 mg\u002Fkg. JLM019 Injection is intended to be administered once a week (QW). However, the dose and interval of administration may be adjusted based on the acquired PK, PD, and safety data. Each treatment cycle is 28 days.The repeated dose is tentatively scheduled to be administered once weekly until one of the following occurs: disease progression, intolerable toxicity, requirement for new antitumor therapy, withdrawal of informed consent form, death, loss to follow-up, or other protocol-specified discontinuation conditions.\n\nSafety profile, DLT, MTD and RED of JLM019 Injection shall be assessed during and after treatment, with PK, PD, immunogenicity and Efficacy analyzed correspondingly.",[26,81,82],"Hodgkin Lymphoma","Non-Hodgkin Lymphoma","2026-05-28",{"date":85,"type":34},"2026-06-03",{"date":87,"type":34},"2026-01-13",{"date":89,"type":20},"2029-07-01",{"name":91,"class":41},"Jecho Biopharmaceuticals Co., Ltd.",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100626359","phase-1-evaluation-of-t320-an-anti-tissue-factor-antibody-drug-conjugate-in-patients-with-advanced-solid-tumors-100626359","NCT07434609","Evaluation of T320, an Anti-Tissue Factor Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors","An Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of T320, an Anti-Tissue Factor Antibody-Drug Conjugate, in Patients With Advanced Solid Tumor","Inclusion Criteria:\n\n* Voluntary to participate in the clinical study, sign a written informed consent form, and able to comply with clinical visits and study-related procedures.\n* Age ≥18 years old upon signing the informed consent form.\n* Have histologically and\u002For cytologically confirmed unresectable advanced solid tumour who are refractory to or intolerant of available standard-of-care therapy or have no effective standard treatment available.\n\nEscalation module: preferred tumour types include cervix, ovary, endometrium, pancreatic, bladder, prostate, esophageal cancer, HNSCC, triple-negative breast cancer (TNBC), cholangiocarcinoma, and NSCLC. Backfill module: patients with cervix cancer, pancreatic cancer, HNSCC, NSCLC, ovarian and endometrial cancer.\n\n* ECOG performance score of 0 \\~ 2.\n* Life expectancy ≥ 3 months.\n* At least one measurable lesion per RECIST v1.1.\n* Adequate organ function defined as following: a) Hematological status: neutrophil count (ANC) ≥ 1.5×109\u002FL, platelet count (PLT) ≥ 90×109\u002FL, and hemoglobin (HGB) \\> 9.0 g\u002FdL (no blood transfusion or hematopoietic stimulating factor therapy within 14 days before the evaluation). b) Coagulation function: international normalized ratio (INR) ≤1.2 (without anticoagulant therapy) and activated partial prothrombin time (APTT) ≤1.25×ULN. c) Liver function: total bilirubin (TBIL) ≤ 1.5×ULN or ≤ 3×ULN in case of Gilbert's syndrome; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5×ULN, if there is liver metastasis, ALT and AST ≤ 5×ULN. d) Renal function: creatinine clearance (Cockcroft-Gault) ≥ 60 mL\u002Fmin. e) Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%; QTcF≤470 ms by Fridericia formula.\n* Eligible patients with fertility (male and female) must agree to use reliable contraceptive methods with their partners during the trial period and at least 3 months after the last IP administration; female patients of childbearing age must have a negative serum pregnancy test within 7 days before the first investigational drug administration.\n* Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.\n\nExclusion Criteria:\n\n* Any anti-cancer therapy including chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment.\n* Known past or current coagulation defects leading to an increased risk of bleeding or any known bleeding diathesis.\n* History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.\n* Known to be allergic to T320 for injection or any of its excipients, or patients with allergic constitution.\n* Known or suspected severe allergy\u002Fhypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies.\n* Known history of non-infectious pneumonitis (NIP)\u002Finterstitial lung disease (ILD) requiring systemic steroids, active NIP\u002FILD, or other severe lung disease.\n* Presence of grade ≥ 2 peripheral neuropathy.\n* Ongoing acute or chronic inflammatory skin disease.\n* Presence of ocular surface disease (i.e., confluent superficial keratitis, cornea epithelial defect, corneal ulcer, stromal opacity, etc) or history of conjunctivitis.\n* Presence of acute bacterial, viral or fungal infections.\n* Untreated, unstable or uncontrolled central nervous system (CNS) metastases, except for: a) No evidence of cerebral edema and no systemic steroids or anticonvulsants requirement at screening and follow-up MRI scan performed within 28 days prior to the first dose of the IMP showing no progression of treated lesion(s) and no new lesion(s) appearing. b) Untreated asymptomatic brain metastasis and no need of local\u002Fsystematic therapy currently.\n* Any prior therapy with a conjugated or unconjugated auristatin derivative.\n* Patient requiring concurrent treatment of strong inhibitors or inducers of cytochrome P450 3A4 (Table 3) within 2 weeks prior to the first dose and during the study treatment.\n* Have previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation, or plan to receive allogeneic hematopoietic stem cell transplantation or solid organ transplantation during the study period.\n* History of or currently central nervous system (CNS) lymphoma or other central nervous system diseases.\n* Known to have any active infection of human immunodeficiency virus (HIV),hepatitis B virus (HBV) or hepatitis C virus (HCV). However, patients with the following conditions can be included in this study: a) Human immunodeficiency virus antibody (HIV-Ab) is negative, or HIVAb is positive but nucleic acid test shows an undetectable viral load (viral suppression is defined as having less than 200 copies of HIV per milliliter of blood) i.e., well-controlled HIV patients can be enrolled. b) Hepatitis B surface antigen (HBsAg) is negative; if HBsAg or HBcAb is positive, HBV-DNA (HBV deoxyribonucleic acid) \\\u003C 1000 cps\u002FmL. c) Hepatitis C virus antibody (HCV-Ab) is negative.\n* Toxicity except for alopecia and fatigue caused by previous anti-tumour therapy has not been alleviated to grade 1 or below (CTCAE v5.0).\n* History of other malignant tumor within 2 years before enrollment, except for skin basal cell carcinoma, skin squamous cell carcinoma, and carcinoma in situ that have undergone possible curative treatment and have not recurred within 5 years after the start of treatment.\n* Have received any other investigational drug product within 28 days or 5 halflives of the previous investigational drug (if required) before screening.\n* Have used live attenuated vaccines within 4 weeks before the first administration of dexamethasone or are expected to use live attenuated vaccines during the study period.\n* Have used systemic immunosuppressive drugs within 4 weeks before the first administration, including but not limited to radiotherapy immunoconjugates, antibody-drug conjugates, immune\u002Fcytokines, monoclonal antibodies, etc. Except for continuous corticosteroids at a dose of \\\u003C10 mg prednisone\u002Fday or equivalent.\n* History of autoimmune diseases, including but not limited to myocarditis, pneumonia, myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Wegener's granulomatosis, multiple sclerosis, vasculitis or glomerulonephritis.\n* Have undergone major organ surgery (excluding needle biopsy) or had significant trauma within 4 weeks before the first administration of IP, or need to undergo elective surgery during the trial period.\n* Have serious unhealable wound\u002Fulcer\u002Ffracture within 4 weeks before the first administration of investigational drug.\n* History of serious cardiovascular and cerebrovascular diseases, including but not limited to:1) Serious heart rhythm or conduction abnormalities, such as ventricular arrhythmia that requires clinical intervention, degree II-III atrioventricular block, etc. 2) Thromboembolic events requiring therapeutic anticoagulation, or subjects with venous filters. 3) Patients with Class III\\~IV cardiac insufficiency according to the New York Heart Association (NYHA) criteria. 4) Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 and above cardiovascular and cerebrovascular events within 6 months before the first administration.\n\n  5\\) Clinically uncontrollable hypertension (blood pressure cannot be controlled at systolic blood pressure \\\u003C140 mmHg and diastolic blood pressure \\\u003C90 mmHg after standard antihypertensive treatment). 6) Any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, or use of any concomitant drug that are known to or may prolong the QT interval.\n* Substance use disorder that may interfere with the participant's involvement in the study or evaluation of the study result, as determined by the investigator.\n* Patient with mental disorders that would affect participation in the trial or poor compliance.\n* Women who are pregnant or breastfeeding.\n* Patient who cannot tolerate venous blood sampling.\n* The investigator believes that the subject has a history of other serious systemic diseases or is not suitable for participating in this clinical study for other reasons.",{"count":100,"type":20},150,[23],"This is a first-in-human, non-randomized, open-label, multi-center, phase I study in patients with advanced solid tumor to evaluate the safety and tolerability, PK, immunogenicity, and preliminary anti-tumour activity of T320. This study consists of a dose escalation module and a backfill module. The trial process for each subject in both escalation and backfill module includes a screening period (28 days before the first T320 administration), a treatment period (from the first T320 administration to the end of reatment), a safety follow-up period (28 days after EOT\u002Fearly withdrawal) and a progression follow-up period (every 12 weeks from safety follow-up visit). Patients will receive T320 administration once every 2 weeks (Q2W) and 28 days are set as one treatment cycle.",[26],"NOT_YET_RECRUITING","2026-02-20",{"date":107,"type":34},"2026-02-25",{"date":109,"type":20},"2027-12-01",{"date":111,"type":20},"2030-12-01",{"name":113,"class":41},"Nanolattix Biotechnology Co., Ltd.",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":121,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":143},"100602431","phase-1-a-phase-1-study-of-apx-343a-as-monotherapy-or-in-combination-with-pembrolizumab-in-subjects-with-advanced-solid-tumors-100602431","NCT07123415","A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors","A Phase 1 Trial of APX-343A as Monotherapy or in Combination With Pembrolizumab to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male or female subjects aged ≥19 years, inclusive, at the time of informed consent.\n2. Willing and able to give informed consent and to comply with the requirements of the study.\n3. Histologically or cytologically confirmed advanced solid tumor.\n4. Life expectancy of at least 3 months in the judgment of the investigator.\n5. ECOG performance status of 0 to 1 during the screening period.\n6. Measurable disease per RECIST v1.1 as assessed by the site investigator\u002Fradiology.\n7. Archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated has been provided.\n8. Subjects who have AEs due to previous anticancer therapies must have recovered to ≤ Grade 1 or baseline.\n9. Adequate organ function as defined in the following table.\n10. Subjects who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to the first dose of study drug.\n11. Subjects with history of HCV infection are eligible if HCV viral load is undetectable at screening.\n12. Male subjects must agree to use an adequate method of contraception.\n13. Female subjects of childbearing potential must agree to use highly effective contraceptive methods, and to abstain from breastfeeding.\n\nExclusion Criteria:\n\n1. Received any prior immunotherapy.\n2. Received prior systemic anticancer therapy including investigational agents.\n3. Received prior radiotherapy.\n4. Received a live or live-attenuated vaccine .\n5. Has received an investigational agent.\n6. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.\n7. Known additional malignancy.\n8. Known active CNS metastases and\u002For carcinomatous meningitis.\n9. Active autoimmune disease.\n10. History of (noninfectious) pneumonitis\u002Finterstitial lung disease.\n11. Active, uncontrolled infection requiring systemic therapy.\n12. Unable to swallow study drug or disease that interfere with proper absorption of study drug.\n13. Significant cardiovascular disease.\n14. Cerebrovascular accident.\n15. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the subject's ability to cooperate with the requirements of the study.\n16. History of severe hypersensitivity to pembrolizumab and\u002For any of its excipients.\n17. History of hypersensitivity to APX-343A and\u002For any of its excipients.\n18. History of allogeneic tissue\u002Fsolid organ transplant.\n19. History of HIV infection or HIV positive at screening.\n20. Subjects who have not adequately recovered from major surgery or have ongoing surgical complications.","19 Years",{"count":123,"type":20},110,[23],"This is a Phase 1, open-label, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of APX-343A monotherapy (Part A) and in combination with pembrolizumab (Part B) in subjects with advanced solid tumors.",[127,26],"Advanced Solid Cancer",[127,26,129,130,131,132],"APX-343A","ICI","CAF","NOX","2025-11-17",{"date":135,"type":34},"2025-11-19",{"date":137,"type":34},"2025-10-24",{"date":139,"type":20},"2028-12",{"name":141,"class":142},"Aptabio Therapeutics, Inc.","INDIV",3,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":153,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":67},"100556607","phase-2-a-multicenter-open-label-single-arm-phase-ii-study-of-nhwd-870-hcl-in-adults-and-adolescents-with-advanced-nut-cancer-100556607","NCT06527300","A Multicenter, Open-label, Single-arm, Phase II Study of NHWD-870 HCl in Adults and Adolescents with Advanced NUT Cancer","Inclusion Criteria:\n\n* A written informed consent signed;\n* Subjects must sign and date IEC-approved written informed consent in accordance with the guidelines of the competent authorities and research institutions. Informed consent had to be obtained before any protocol-related procedure that was not part of a participant's routine care was performed.\n* Participants must be willing and able to comply with the scheduled visits, treatment protocols, laboratory tests, and other requirements of the study;\n* If the subjects were under 18, the participants and their legal guardian authorization signed agreement;\n* Both sexes, the first part (adult group) was ≥18 years old and ≤75 years old, the second part (adolescent group) was ≥12 years old and \\\u003C18 years old;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;\n* The expected survival period for 3 months or more;\n* The histopathological (histopathological diagnosis was the first time according to the tumor tissue pathologic specimens before three years, if more than 3 years should be confirmed in the center of the study to do a biopsy. If, in the investigator's judgment, a biopsy might increase a subject's risk, archival tumor tissue samples up to 3 years old could be collected after discussion with the sponsor) were diagnosed as midline (NUT) cancer by, but not limited to:\n* Determination of ectopic NUT protein expression by IHC;\n* Detection of NUT gene translocations by fluorescence in situ hybridization (FISH);\n* Detection of NUT gene translocations (e.g. BRD3\u002F4 mutation or ≥ 2-fold amplification) by DNA\u002FRNA sequencing.\n\nExclusion Criteria:\n\n* Prior treatment with a BET inhibitor;\n* 3 years before into the group suffering from other malignant tumors, with the exception of removal of cure of basal cell carcinoma, orthotopic bladder cancer or cervical carcinoma in situ;\n* The researchers believe the subjects is the need for systemic anti-infection treatment of active infection;\n* Patients with clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.\n* Imaging shows that the tumor has invaded important blood vessels or the investigators judge that the tumor is likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study.","12 Years","75 Years",{"count":19,"type":20},[154],"PHASE2","This is a multicenter, open-label, single-arm, phase II study to evaluate the efficacy, safety, and pharmacokinetics of NHWD-870 HCl in adults and adolescents with advanced NUT cancer.",[26],[158],"NHWD-870","2025-01-21",{"date":161,"type":34},"2025-01-24",{"date":163,"type":34},"2024-04-25",{"date":165,"type":20},"2025-12-30",{"name":167,"class":168},"Zhejiang Wenda Pharma Technology LTD.","OTHER"]