[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-or-metastatic-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-or-metastatic-solid-tumors":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,60,86,108,131,160,195,217,242,279,303,323,344,372,393,413,441,462,484],{"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":39,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100480603","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-07799544-as-monotherapy-or-in-combination-in-people-with-advanced-solid-tumors-100480603",false,"NCT05538130","A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors","A PHASE 1A\u002FB OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS","Phase 1b Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor (excluding colorectal cancer)\n* Measurable disease by RECIST version 1.1\n* Evidence of a BRAF V600 mutation\n* Prior therapy per tumor cohort\n* Adequate organ function per protocol\n\nPhase 1b Exclusion Criteria:\n\n* Other active malignancy within 3 years\n* Presence of leptomeningeal disease\n* History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)\n* Active gastrointestinal disease as defined per protocol\n* History of interstitial lung disease as defined per protocol","ALL","16 Years",{"count":19,"type":20},124,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).\n\nPhase 1a is no longer open for enrollment. In Phase1b (noted as \"this study\"), we are seeking participants who have:\n\n* a solid tumor which is metastatic or recurrent (excluding colorectal cancer)\n* tumor with the mutation (abnormal gene) called \"BRAF V600\"\n* received required prior treatment for cancer per cohort assigned.\n\nAll participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.\n\nParticipants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.",[26,27,28,29,30,31,32,33,34,35,36,37,38],"Melanoma","Glioma","Thyroid Cancer","Non-Small Cell Lung Cancer","Malignant Neoplasms","Brain Neoplasms","Advanced or Metastatic Solid Tumors","HGG","LGG","Low Grade Glioma","High Grade Glioma","Differentiated Thyroid Cancer","NSCLC (Non-small Cell Lung Cancer)",[40,41,42,43,44,45,46],"solid tumors","BRAF","advanced solid tumors","B-Raf","MAPK","neoplasms","BRAF V600","RECRUITING","2026-06-29",{"date":50,"type":51},"2026-07-01","ACTUAL",{"date":53,"type":51},"2022-11-30",{"date":55,"type":20},"2029-06-18",{"name":57,"class":58},"Pfizer","INDUSTRY",83,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":72,"conditions":73,"keywords":74,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100608758","phase-1-a-study-of-tak-188-in-adults-with-advanced-or-spreading-solid-tumors-100608758","NCT07205718","A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors","An Open-label, Dose Escalation and Expansion, Phase 1\u002F2 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TAK- 188, an Anti-CCR8 Antibody-Drug- Conjugate, as a Single Agent in Adult Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Participants ≥18 years or ≥ the local legal age of majority, as applicable, at the time of signing the ICF.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n3. Participants must provide biopsy samples (core needle or other surgical procedure) collected within 28 days prior to C1D1 and also on treatment unless procedure is determined to be unsafe following discussion with sponsor. Participants with an archival biopsy specimen collected within 90 days prior to C1D1 of TAK-188 who have not received any other cancer-specific treatment (with the exception of adjuvant endocrine therapy for a history of breast cancer) at least 14 days prior to the biopsy and throughout the period leading up to C1D1 may use that archival specimen in lieu of a new pretreatment biopsy. Archival biopsy from the same tumor must be provided, if available.\n4. Adequate bone marrow, renal, and hepatic functions, as determined by the following laboratory parameters:\n\n   1. Absolute neutrophil count (ANC) ≥1500 per microliter (μL), platelet count ≥75,000\u002FμL, and hemoglobin (Hgb) ≥8.0 g\u002FdL without growth factor support for ANC or transfusion support for platelets within 14 days before the first trial treatment dose. Transfusion of packed red blood cells is allowed, post infusion Hgb must be greater than 8.0 g\u002FdL.\n   2. Total bilirubin ≤1.5 times the institutional upper limit of the normal range (ULN). For participants with Gilbert's disease, ≤3 milligrams per deciliter (mg\u002FdL).\n   3. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN or baseline or ≤5.0 × ULN or baseline with liver metastases.\n   4. Albumin ≥3.0 grams per deciliter (g\u002FdL).\n   5. Calculated creatinine clearance CLCR (using the Cockcroft-Gault formula) ≥60 mL\u002Fminute.\n   6. Left Ventricular Ejection Fraction (LVEF) \\>50%, as measured by echocardiogram or multiple-gated acquisition scan (MUGA) within 4 weeks before receiving the first dose of TAK-188.\n5. Clinically significant toxic effects of previous therapy have recovered to Grade 1 (per NCI CTCAE v5.0) or baseline, except for alopecia, Grade 2 peripheral neuropathy, and\u002For autoimmune endocrinopathies with stable endocrine replacement therapy.\n6. Female participants must be:\n\n   1. Postmenopausal (natural amenorrhea and not due to other medical reasons) for at least 1 year before the screening visit, or\n   2. Surgically sterile, or\n   3. If they are of childbearing potential, agree to practice 2 effective methods of contraception at the same time, from the time of signing the informed consent through 180 days after the last dose of TAK-188, or\n   4. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant.\n   5. Periodic abstinence (for example, calendar ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.\n7. Male participants, even if surgically sterilized (that is, status postvasectomy), must:\n\n   1. Agree to practice effective barrier contraception (that is, a condom) during the entire trial treatment period and through 180 days after the last dose of TAK-188, or\n   2. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant.\n   3. Periodic abstinence (for example, calendar ovulation, symptothermal, postovulation methods), withdrawal, and spermicides only are not acceptable methods of contraception.\n8. Voluntary written consent must be given before performance of any trial-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.\n9. Participants with controlled Human Immunodeficiency Virus (HIV) are allowed:\n\n   1. Cluster of differentiation 4 (CD4) cell count greater than 350 cell per cubic millimeters (cell\u002Fmm\\^3).\n   2. Viral load undetectable for at least a year.\n10. The following solid tumor participants will be allowed:\n\n    a. Participants with the following pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic solid tumors, who have progressed on all standard, curative, or life-prolonging treatments (or are intolerant to all available standard therapies): i. Gastroesophageal (esophageal, gastroesophageal junction, and gastric) adenocarcinoma and squamous cell carcinoma.\n\n    ii. PDAC. iii. Nonsquamous and squamous NSCLC (participants with actionable genomic alteration \\[AGAs\\] are allowed in dose escalation only).\n\n    iv. squamous cell carcinoma of head and neck (SCCHN). v. Colorectal cancer.\n11. Participants with metastatic or advanced solid tumors must have radiographically measurable disease per RECIST Version 1.1. Lesions to be used as measurable disease for the purpose of response assessment must either a) not reside in a field that has been subjected to prior radiotherapy or b) have demonstrated clear evidence of radiographic progression since the completion of prior radiotherapy and before trial enrollment or c) have been radiated at least 6 months before trial enrollment or d) should not be the same lesion selected for mandatory biopsy at screening.\n12. For expansion in NSCLC (post programmed cell death-ligand 1 \\[PD-L1\\] treatment):\n\n    1. Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic NSCLC.\n    2. Participants must have tested negative for a known AGA (for example, estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), mesenchymal epithelial transition \\[MET\\], c-ros oncogene 1 \\[ROS1\\], BRAF).\n    3. Must have had disease progression in the advanced or metastatic setting. No more than 1 line of therapy in advanced or metastatic setting is permitted.\n    4. Participants must have received at least 6 weeks of 1 prior anti-PD-(L)1 therapy, and this must have been given during the immediately preceding line of therapy. Anti-PD-(L)1 therapy may have been given in the metastatic or neoadjuvant setting.\n    5. Participants are eligible regardless of PD-L1 status but this information must be provided.\n    6. NOTE: Prior anti-PD-(L)1 therapy may have been given with or without an anti-CTLA-4 antibody and\u002For chemotherapy (for example, carboplatin and pemetrexed).\n13. For Phase 1 backfill and possible expansion, in SCCHN (post PD-(L)1 treatment):\n\n    1. Participants with histologically confirmed (cytological diagnosis is acceptable) metastatic or unresectable, recurrent SCCHN that is considered incurable by local therapies. Participants should have PD-(L)1 monotherapy or in combination with chemotherapy administered in the recurrent or metastatic setting or neo-adjuvant\u002Fadjuvant. Anti-PD-(L)1 therapy must have been given during the immediately preceding line of therapy. No more than 1 line of therapy in advanced or metastatic setting is permitted.\n    2. Anatomic subsites to be included are oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, and paranasal sinuses (maxillary, ethmoid, sphenoid, and frontal). The exception to this is nasopharyngeal cancer and salivary gland tumors, which will not be included.\n    3. Participants with oropharyngeal cancer or tumors arising in the paranasal sinuses (maxillary, ethmoid, sphenoid, and frontal) must agree to provide archival tissue for human papillomavirus (HPV) testing or if known, HPV testing results using CINtec p16 histology assay and a 70% cutoff point must be provided. If HPV status was previously tested using this method, no additional testing is required. Otherwise, if another validated HPV assay was performed, tissue will be required for central confirmation.\n    4. Tumors must have a PD-L1 CPS ≥1.\n14. For dose expansion in gastroesophageal adenocarcinoma (GEA) (post PD-(L)1 treatment):\n\n    1. Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic gastroesophageal (esophageal, gastroesophageal junction, and gastric) adenocarcinoma.\n    2. Must have had disease progression while on or following 1 prior line of therapy:\n    3. Disease progression while on or following at least 6 weeks of 1 prior anti-PD-(L)1 therapy in the recurrent locally advanced or metastatic setting. Prior anti-PD-(L)1 therapy may have been given with or without chemotherapy (for example, mFOLFOX or CAPOX); CAPOX); HER-2 positive participants must have received trastuzumab. Anti-PD-(L)-1 therapy must have been given during the immediately preceding line of therapy. No more than 1 line of therapy in advanced or metastatic setting is permitted.\n    4. Tumors must have a PD-L1 CPS ≥1.\n\nExclusion Criteria:\n\n1. History of any of the following cardiac illnesses within 6 months before first dose of TAK-188:\n\n   1. Congestive heart failure New York Heart Association Grade III or IV.\n   2. Unstable angina, myocardial infarction.\n   3. Persistent hypertension ≥160\u002F100 mm mercury (Hg) despite optimal medical therapy.\n   4. Ongoing cardiac arrhythmias of Grade \\>2 (including atrial flutter\u002Ffibrillation or intermittent ventricular tachycardia).\n   5. Other ongoing serious cardiac conditions (for example, Grade 3 pericardial effusion or Grade 3 restrictive cardiomyopathy).\n   6. Symptomatic cerebrovascular events.\n   7. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular-weight heparin, is allowed.\n2. Baseline prolongation of Fridericia-corrected QT interval (QTcF) (for example, repeated demonstration of QTc \\>480 milliseconds, history of congenital long QT syndrome, or torsades de pointes) on a 12-lead ECG during the screening period. If participants are taking medications known to prolong QTc at screening, participants may continue to take these medications as long as their baseline QTcF is \\\u003C480 milliseconds. Participants may not start using such medications on or after C1D1.\n3. Oxygen saturation of \\\u003C90% of room air at screening.\n4. Participants treated with other chemokine (C-C motif) receptor 8 (CCR8) targeting agents within the past 6 months.\n5. Active diagnosis of lung conditions including:\n\n   1. Pneumonitis.\n   2. Interstitial lung disease.\n   3. Severe chronic obstructive pulmonary disease.\n   4. Idiopathic pulmonary fibrosis.\n   5. Other restrictive lung diseases.\n   6. Acute symptomatic pulmonary embolism.\n   7. Grade ≥2 pleural effusion not controlled by tap or requiring indwelling catheters.\n6. History of known brain metastasis or leptomeningeal disease unless:\n\n   1. Brain metastases are stable on cranial imaging (that is, ≥4 weeks) following prior surgery, whole-brain radiation OR\n   2. Stereotactic radiosurgery and off corticosteroids for brain metastases\n   3. Must be without neurologic dysfunction that would confound the evaluation of neurologic and other AEs.\n7. Grade ≥2 fever of malignant origin.\n8. Systemic infection requiring IV antibiotic therapy or other serious infection within 14 days before the first dose of TAK-188 or severe infections on continued treatment.\n9. Participants with uncontrolled, known or suspected, autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n10. Participants with a diagnosis of an identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, uncontrolled HIV infections, organ transplantation).\n11. Chronic, active hepatitis (for example, participants with known hepatitis B surface antigen seropositive and\u002For detectable HCV RNA). Note:\n\n    1. Participants who have positive hepatitis B core antibody can be enrolled but must have an undetectable serum hepatitis B virus-DNA.\n    2. Participants who have positive HCV antibody must have an undetectable HCV-RNA serum level.\n12. Prior or current clinically significant ascites, as measured by physical examination, that requires active paracentesis for control.\n13. Any pre-existing medical or psychiatric condition or illness, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug or that would limit compliance with trial requirements or compromise ability to provide written informed consent. Participants with a history of PE on anti-coagulation are permitted unless symptomatic requiring oxygen supplementation.\n14. Recent major surgery where the participant has not fully recovered based on physician assessment.\n15. Recent major bleeding event that has not resolved, and the underlying reason for bleeding has not been corrected.\n16. Participant with concurrent malignancy requiring active treatment, with the exception of participants on chronic hormonal therapy.\n17. Treatment with fully human\u002Fhumanized antineoplastic monoclonal antibodies less than 4 weeks or the time period equal to the dosing interval, whichever is shorter. No washout period is required for prior treatment with anti-PD-(L)1 antibodies.\n18. Treatment with any investigational products or other anticancer therapy (including chemotherapy, targeted agents, and immunotherapy), within 14 days or 5 half-lives, whichever is shorter, before C1D1 of TAK-188.\n19. Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy (with the exception of adjuvant endocrine therapy for a history of breast cancer). Concurrent use of hormones for noncancer-related conditions is acceptable (except for corticosteroid hormones).\n20. Radiation therapy within 14 days (42 days for radiation to the lungs) and\u002For systemic treatment with radionuclides within 42 days before C1D1 of TAK-188. Participants with clinically relevant ongoing pulmonary complications from prior radiation therapy are not eligible.\n21. Use of systemic corticosteroids or other immunosuppressive therapy, concurrently or within 7 days of C1D1 of TAK-188, with the following exceptions:\n\n    1. Topical, intranasal, inhaled, ocular, intra-articular, and\u002For other nonsystemic corticosteroids.\n    2. Physiological doses of replacement steroid therapy (for example, for adrenal insufficiency).\n    3. Single doses of steroids (for example, for imaging premedication) within the 7-day timeframe may be allowed after clarification with sponsor.\n22. Receipt of live attenuated vaccine (for example, tuberculosis Bacillus Calmette-Guerin vaccine, oral polio vaccine, measles, rotavirus, yellow fever) within 28 days of C1D1 of TAK-188. Non-live, approved vaccines are allowed (for example, COVID-19 vaccine).\n\n    a. Note: COVID-19 vaccination should not be given within ±3 days of systemic trial treatments.\n23. Recipients of stem cell transplantation or organ transplantation.\n24. Female participants who are lactating or have a positive serum\u002Furine pregnancy test during the screening period or a positive serum\u002Furine pregnancy test on Day 1 before first dose of TAK-188.\n\n    a. Note: Female participants who are lactating will be eligible if they choose to discontinue breastfeeding before the first dose of TAK-188.\n25. Participant is a trial site employee, a site employee's immediate family member (for example, spouse, parent, child, sibling), or is in a dependent relationship with a site employee who is involved in conduct of this trial or may consent under duress.\n26. Participant is considered to be vulnerable, as defined per local regulations and if exclusion is required by local regulations. Examples are persons under safeguard of justice, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care without their consent, persons admitted to a health or social establishment for purposes other than research, persons of full age who are subject to a legal protection measure (guardianship or curatorship), and persons unable to express their consent.","18 Years",{"count":69,"type":20},223,[23,71],"PHASE2","TAK-188 is a new medicine that targets a protein called CCR8, which is found on the surface of certain cells (Tregs) inside tumors. These cells can weaken the body's ability to fight cancer. TAK-188 may help to remove these Tregs. Removing these Tregs may allow more cancer-fighting cells (CD8+ T cells) to attack the tumor and potentially stop tumors from growing.\n\nIn this study, researchers want to learn if TAK-188 can help the body's immune system better fight cancer in adults with advanced cancers which have not gotten better with regular treatments. The main aims of this study are to check if TAK-188 is safe in adults with advanced or spreading (metastatic) solid tumors, if participants tolerate the treatment with TAK-188 and to learn if TAK-188 works well in adults with certain advanced cancers after their previous treatments didn't work. Participants may receive TAK-188 for up to 1 year. Their health will be monitored after the treatment has ended for up to another year.",[32],[75],"Drug Therapy","2026-06-12",{"date":78,"type":51},"2026-06-15",{"date":80,"type":51},"2025-11-19",{"date":82,"type":20},"2029-12-21",{"name":84,"class":58},"Takeda",15,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100535175","phase-1-a-clinical-study-of-kk2260-in-patients-with-advanced-or-metastatic-solid-tumors-100535175","NCT06248411","A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors","A Phase 1, Uncontrolled, Open-label, Non-randomized, Dose-escalation Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors, Followed by an Uncontrolled, Non-randomized Study and an Uncontrolled, Randomized Study in Patients With Esophageal Squamous Cell Carcinoma or Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n\\\u003CCommon Inclusion Criteria for Part 1a, Part 1b, and Part 2\n\n1. Patients who have given informed written consent.\n2. Male or female subjects ≥18 years of age, at time of signing informed consent.\n3. Subjects who are refractory to standard treatment, intolerant of standard treatment, for whom standard treatment does not exist, or who have refused standard treatment.\n4. Patients with measurable disease according to RECIST version 1.1\n5. Patients who have had the certaion periods between the date of completion of prior therapy and the date of enrollment\n6. Subjects who agree to have a tumor biopsy as part of the baseline examination. Patients who have difficulty in performing a tumour biopsy and have agreed to submit a previously collected stored specimen.\n7. Patients with an ECOG PS of 0 or 1 at baseline.\n8. Patients with haematopoietic, hepatic, renal, cardiac and respiratory functions that meet certain criteria in a baseline test.\n\n\\\u003CAdditional Inclusion Criteria for Part 1a\n\n1\\) Patients with pathologically diagnosed advanced or metastatic solid tumors.\n\n\\\u003CAdditional Inclusion Criteria for Part 1b\n\n1. Patients with pathologically diagnosed with advanced or metastatic esophageal cancer, or advanced or metastatic head and neck cancer whose primary site of origin is the oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, or paranasal sinuses.\n2. Patients with pathologically diagnosed squamous cell carcinoma.\n3. Patients who agree to undergo tumor biopsy after administration.\n\n\\\u003CAdditional Inclusion Criteria for Part 2a\n\n1. Patients with pathologically diagnosed with advanced or metastatic esophageal cancer.\n2. Patients with pathologically diagnosed squamous cell carcinoma.\n3. Patients who agree to undergo tumor biopsy after administration.\n\n\\\u003CAdditional Inclusion Criteria for Part 2b\n\n1. Patients with advanced or metastatic head and neck cancer whose primary site of origin is the oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, or paranasal sinuses.\n2. Patients with pathologically diagnosed squamous cell carcinoma.\n3. Patients who agree to undergo tumor biopsy after administration.\n\nExclusion Criteria:\n\n\\\u003CCommon Exclusion Criteria to Part 1 and Part 2\\>\n\n1. Patients with central or brain pia mater metastases that are untreated and symptomatic or that require treatment.\n2. Patients with concurrent multiple or synchronous cancers, or with iatrogenic multiple or synchronous cancers with a disease-free interval of 5 years or less.\n3. Patients receiving continuous systemic administration of steroids or other immunosuppressive drugs.\n4. Patients who have had a Grade 3 or higher allergic reaction to an antibody agent or an additive of the study drug.\n5. Patients who have not recovered to Grade 1 or below from adverse events caused by previously administered anticancer therapy.\n6. Patients with active interstitial lung disease or a history of active interstitial lung disease.\n7. Patients with infectious diseases requiring systemic treatment.\n8. Patients with a fever of 38.0°C or higher at the time of registration.\n9. Patients who test positive for Hepatitis B virus antigen or antibody, Hepatitis C virus antibody, or HIV antibody in a baseline test.",{"count":94,"type":20},189,[23],"This is the first in human study of KK2260. In Part 1a, the maximum tolerated dose (MTD) will be determined while evaluating the safety and tolerability of KK2260 in patients with advanced or metastatic solid tumors (any cancer type). In Part 1b and Part 2, at least two dosing regimens and two dosing regimens by cancer type, respectively, will be selected, and the safety, tolerability, and efficacy of each regimen will be evaluated.",[32],"2026-05-25",{"date":100,"type":51},"2026-05-27",{"date":102,"type":51},"2023-11-01",{"date":104,"type":20},"2030-04-30",{"name":106,"class":58},"Kyowa Kirin Co., Ltd.",14,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100612955","phase-1-a-phase-i-study-to-investigate-the-safety-and-tolerability-of-kgx101-monotherapy-and-combination-therapy-with-envafolimab-in-advanced-or-metastatic-solid-tumor-patients-100612955","NCT07260305","A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients","A Phase I , Open Label, Multi-center Study to Assess the Safety and Tolerability of KGX101 Mono and Combo Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients","Inclusion Criteria:\n\n1. Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard of care, no further standard can be used, or standard of care is not fit;\n2. Eastern cooperative oncology grous performance status of 0-1;\n3. Has at least 1 measurable lesion per RECIST 1.1;\n4. Has adequate organ and bone marrow function as per study which including hemoglobin \\> 90 g\u002FL, platelet count \\>=100\\*10e9\u002FL, absolute meutrophil count \\>=1.5\\*10e9\u002FL;\n5. Life expectancy of at least 3 months;\n6. Provision of signed and dated written inform consent prior to any study-related procedures, sampling and analyses.\n\nExclusion Criteria:\n\n1. Active known second malignancy except adequately treated basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer, breast cancer;\n2. Patients with primary CNS malignancies;\n3. Evidence of severe or uncontrolled systemic diseases, including: active infection, hypertension, chronically unhealed wound or ulcers;\n4. Active autoimmnue disease requiring systemic treatment in the last 2 years, or immunodefiency which is on immunosuppressive therapy, chronic systemic or enteric steroid therapy;\n5. History of pneumonitis, interstitial lung disease which require steroids or has current pneumonitis\u002F interstitial lung disease;\n6. Any unresolved toxicities from prior therapy greater than CTCAE 5.0 grade 1.","75 Years",{"count":117,"type":20},57,[23],"This is a phase I, open-label, multi-center, dose escalation and expansion study in advanced or metastatic solid tumor patients. The're are two goals set in this study: one is to explore the safety and tolerability of KGX101 when mono and combo with envafolimab in Chinese patients, the other is to determine recommended phase 2 dose of KGX101 mono and combo with envafolimab. Participants will: 1. Take drug KGX101 mono or combo with envafolimab every 3 weeks; 2. Visit the clinic for checkups and tests. Schedule will be about 6-8 times in the first month and then about every 3 weeks afterwards.",[32],"2026-04-23",{"date":123,"type":51},"2026-04-24",{"date":125,"type":51},"2024-11-27",{"date":127,"type":20},"2027-03-30",{"name":129,"class":58},"Kangabio AUSTRALIA LTD PTY",3,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":115,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100632218","phase-1-prism-nk-precision-matched-allogeneic-single--or-dual-target-car-nk-cells-for-advanced-solid-tumors-100632218","NCT07510828","PRISM-NK: Precision-Matched Allogeneic Single- or Dual-Target CAR-NK Cells for Advanced Solid Tumors","A Phase 1\u002F2 Biomarker-Guided Platform Study of Allogeneic Donor-Derived Single-Target or Dual-Target CAR-NK Cell Therapy Selected by Tumor Antigen Profiling (Liquid Biopsy and\u002For Tissue Biopsy) in Participants With Advanced Solid Tumors","PRISM-NK","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of consent.\n* Histologically or cytologically confirmed advanced or metastatic solid tumor that is refractory to, relapsed after, or intolerant of standard therapy, or for which no standard therapy exists.\n* At least 1 measurable lesion per RECIST v1.1.\n* Tumor antigen positivity documented by tissue biopsy and\u002For liquid biopsy using a protocol-specified assay; for dual-target cohort: co-expression of both antigens above threshold.\n* ECOG performance status 0-1.\n* Adequate organ function (hematologic, renal, hepatic) as defined by protocol labs.\n* Ability to undergo lymphodepleting chemotherapy (if required) and receive IV cell infusion.\n* Negative pregnancy test for individuals of childbearing potential; agreement to use effective contraception during study participation and for a protocol-defined period after infusion.\n* Willingness to provide baseline blood samples and, when feasible, tumor biopsy for biomarker analyses.\n\nExclusion Criteria:\n\n* Active, uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection.\n* Known uncontrolled HIV infection; active hepatitis B or hepatitis C with evidence of active replication (per local testing).\n* Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia) that would increase risk from lymphodepletion or infusion.\n* Active central nervous system (CNS) metastases that are symptomatic or require escalating steroids.\n\n(Stable treated CNS disease may be allowed per protocol.)\n\n* Current systemic immunosuppressive therapy (e.g., \\>10 mg\u002Fday prednisone equivalent) within a protocol-defined window prior to lymphodepletion.\n* Prior gene-modified cellular therapy within 3 months or any prior therapy that, in the investigator's judgment, would confound safety evaluation.\n* Prior allogeneic hematopoietic stem cell transplant within 6 months, or active graft-versus-host disease.\n* Pregnant or breastfeeding.\n* Any condition that, in the investigator's opinion, would interfere with study participation, compliance, or interpretation of results.",{"count":140,"type":20},60,[23,71],"This Phase 1\u002F2, open-label, biomarker-guided platform study evaluates the safety, tolerability, and preliminary anti-tumor activity of banked allogeneic donor-derived chimeric antigen receptor natural killer (CAR-NK) cells in adults with advanced solid tumors. During screening, tumor antigen profiling is performed using tissue biopsy and\u002For liquid biopsy (circulating tumor DNA and\u002For circulating tumor cells).\n\nParticipants are assigned to receive either a single-target CAR-NK product (matched to the dominant tumor antigen) or a dual-target CAR-NK product (matched to two co-expressed antigens) to reduce the risk of antigen escape.",[32],[145,146,147,148,149],"allogeneic NK cells","solid tumor","CAR-NK","mesothelin","tumor","2026-03-31",{"date":152,"type":51},"2026-04-06",{"date":154,"type":51},"2026-03-02",{"date":156,"type":20},"2028-04-17",{"name":158,"class":58},"Beijing Biotech",1,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":170,"conditions":171,"keywords":184,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":107},"100546483","phase-1-a-study-of-parg-inhibitor-etx-19477-in-patients-with-advanced-solid-malignancies-100546483","NCT06395519","A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies","ERADIC8","Inclusion Criteria:\n\n* Males and females of age ≥ 18 years at the time of signing the informed consent document.\n* Histologically or cytologically confirmed advanced (incurable recurrent, unresectable, or metastatic) solid cancer, excluding primary central nervous system (CNS) tumors.\n* Any solid tumor malignancy, excluding primary CNS tumors, with progression on or after or intolerance to most recent systemic therapy. Preferential enrollment consideration will be made for patients with known BRCA2 mutations resulting in loss of function.\n* Measurable disease per RECIST v1.1.\n* ECOG performance status 0-1.\n* Progression on or after or intolerance to most recent systemic therapy. Prior treatment in the recurrent\u002Fmetastatic setting; patients must have received approved standard therapy that is available to the patient that is known to confer clinical benefit, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient.\n* No investigational agent within 3 weeks or 5 half-lives (whichever is shorter; minimum of 2 weeks) prior to first dose of study drug.\n* Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Receiving continuous corticosteroids at prednisone-equivalent dose of \\>10 mg\u002Fday. Chronic systemic corticosteroid therapy for physiologic replacement (≤10 mg\u002Fday of prednisone equivalents) and the use of non-systemic corticosteroids (e.g., inhaled, topical, intra-nasal, intra-articular, or ophthalmic) are permitted.\n* Definitive radiotherapy within 6 weeks and palliative radiation within 2 weeks prior to the first dose of study drug.\n* Symptomatic untreated or progressing brain metastases. Stable, treated brain metastases are allowed if no evidence of radiologic or clinical progression or increasing corticosteroid use for at least 4 weeks.\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of ETX-19477 and no history of bowel obstruction within 6 months and\u002For peritoneal fluid drainage within 8 weeks prior to the first dose of study drug.\n* Known symptomatic and radiologically progressing or leptomeningeal disease (LMD). If LMD has been reported radiographically on baseline magnetic resonance imaging (MRI), but is not suspected clinically by the Investigator, the patient must be free of neurological symptoms of LMD.\n* Resting ECG with QT interval calculated using the Fridericia's formula (QTcF) \\>470 msec on 2 or more timepoints within a 24-hour period, or history or family history of congenital long QT syndrome, or taking concomitant medications that are known to prolong the QT\u002FQTc interval, or history of additional risk factors for torsades de pointes (Tdp).\n* History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension, clinically significant uncontrolled arrhythmias, or any history of symptomatic congestive heart failure.\n* Known active or chronic infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B, hepatitis C, or AIDS-related illness. Controlled infections, including HIV and \"cured\" hepatitis C (no active fever, no evidence of systemic inflammatory response syndrome) that are stable with undetectable viral load on antiviral treatment are not exclusionary.\n* Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of patients with Gilbert's Syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per Investigator assessment).\n* Known other previous\u002Fcurrent malignancy requiring treatment within ≤2 years except for limited disease treated with curative intent, such as carcinoma in situ, squamous or basal cell skin carcinoma, or superficial bladder carcinoma and not requiring ongoing chemotherapy.\n* Patients receiving proton pump inhibitors (PPIs), strong cytochrome P450 (CYP)3A inhibitors and inducers, or P-glycoprotein (P-gp) inhibitors. Patients should not receive PPIs within 7 days prior to first dose of study drug. Strong CYP3A inducers or inhibitors or strong P-gp inhibitors should not be given within 6 half-lives prior to first dose of study drug.\n* Patients currently treated with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants",{"count":168,"type":20},120,[23,71],"This is a two-part, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel reversible small molecule inhibitor of PARG.",[32,172,173,174,175,176,177,178,179,180,181,182,183],"Breast Cancer","Ovarian Cancer","Prostate Cancer","Epithelial Ovarian Cancer","BRCA2 Mutation","ER+ Breast Cancer","Castrate Resistant Prostate Cancer","BRCA1 Mutation","BRCA Mutation","Endometrial Cancer","Colorectal Cancer","Gastric Cancer",[185],"PARG Inhibitor","2026-03-24",{"date":188,"type":51},"2026-03-27",{"date":190,"type":51},"2024-05-13",{"date":192,"type":20},"2026-12",{"name":194,"class":58},"858 Therapeutics, Inc.",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":21,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":216},"100534097","phase-1-dose-escalation-and-expansion-study-of-bh3120-alone-or-with-pembrolizuamb-in-advanced-or-metastatic-solid-tumors-100534097","NCT06234397","Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors","A Phase I, Open-Label, Multinational, Multicenter, Dose Escalation and Expansion Study of BH3120, as a Single Agent and in Combination With Pembrolizumab, in Patients With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Have a Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.\n* PD-L1 positive expression (Tumor Proportion Score ≥1% or Combined Positive Score ≥1).\n* Have at least one lesion, not previously irradiated that can be accurately measured per RECIST version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Age of 18 years or older (or country's legal age of majority if the legal age was \\>18 years)\n* Adequate Hematologic and liver function.\n\nKey Exclusion Criteria:\n\n* Has received prior therapy with an anti-4-1BB(CD137) agent.\n* Known active CNS metastases and\u002For carcinomatous meningitis.\n* Known additional malignancy that is progressing or has required active treatment.\n* History of chronic liver disease or evidence of hepatic cirrhosis.\n* History of severe toxicities associated with a prior immunotherapy.\n* Has ongoing or suspected autoimmune disease.\n* Known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, immunocompromised patients.",{"count":203,"type":20},245,[23],"This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, as a single agent and in combination with pembrolizumab, to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors. Dose-Escalation part is planned to establish the MTD or RD for Dose-Expansion part, while Dose-Expansion part is designed to assess potential efficacy of BH3120, as a single agent and in combination with pembrolizumab, when administered at the RD to subjects in indication-specific expansion cohorts.",[32],"2026-03-09",{"date":209,"type":51},"2026-03-11",{"date":211,"type":51},"2023-12-28",{"date":213,"type":20},"2028-01",{"name":215,"class":58},"Hanmi Pharmaceutical Company Limited",10,{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":21,"phases":226,"briefSummary":227,"conditions":228,"keywords":231,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":241},"100497167","phase-1-a-first-in-human-study-of-prth-101-monotherapy---pembrolizumab-in-subjects-with-advanced-malignancies-100497167","NCT05753722","A First-in-human Study of PRTH-101 Monotherapy +\u002F- Pembrolizumab in Subjects With Advanced Malignancies","An Open-Label Phase 1 Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of PRTH-101 Alone or in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Subject must be willing and able to read, understand, and sign an Informed Consent Form.\n2. Subject must be age ≥18 years.\n3. Subject has metastatic or advanced, unresectable malignancy and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed at Screening, excluding hepatocellular carcinoma, sarcomas, and gliomas.\n4. Subject has a pathologically documented advanced\u002Funresectable or metastatic cancer that is refractory to or intolerable to or the subject is unwilling or ineligible to receive standard treatment known to confer benefit or for which no standard treatment is available.\n5. Subject must have an Eastern Cooperative Oncology Group performance status (PS) 0-1.\n6. Subject must have a predicted life expectancy of ≥3 months.\n7. Subject must have the following laboratory values (obtained ≤14 days prior to enrollment):\n\n   1. Calculated creatinine clearance must be ≥30 mL\u002Fmin by Cockcroft-Gault formula calculation\n   2. Total bilirubin ≤1.5 × ULN unless has known history of Gilbert's syndrome (in which case, total bilirubin must be ≤3 × ULN)\n   3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 × ULN, or ≤3 x ULN in the presence of liver metastases\n   4. Hemoglobin ≥9.0 g\u002FdL\n   5. Platelets ≥100 × 109 cells\u002FL 9\n   6. Absolute neutrophil count ≥1.5 ×10 cells\u002FL (without the use of hematopoietic growth factors)\n   7. Corrected QT interval (QTc) ≤470 milliseconds (as calculated by the Fridericia correction formula)\n8. Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 3 days prior to first administration of PRTH-101.\n9. WOCBP and males with female partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 90 days following the last dose of PRTH-101.\n10. Subject must be willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.\n11. Subject must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines or have archived tissue available (Section 12.3) at enrollment.\n\n    a. Subjects with sites of disease not amenable to biopsy may be considered after discussion with the Sponsor.\n12. The subject is not enrolled in any other clinical trial and is not receiving other therapy directed at their malignancy.\n13. The subject is willing to undergo pre-and post-treatment skin biopsies.\n\nExclusion Criteria:\n\n1. Subject has received prior treatment with systemic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune\u002Fcytokines, and monoclonal antibodies (e.g., checkpoint inhibitors) within 28 days or five half-lives of the drug, whichever is shorter.\n2. Subject has ongoing toxicity from prior therapy \\>Grade 1 according to the CTCAE, with the following exceptions. Such exceptions must be assessed by the Investigator (and approved by the Sponsor) as not placing the subject at undue safety risk from participating in this study.\n\n   1. Alopecia, and vitiligo\n   2. Grade ≤2 neuropathy\n   3. Well-controlled hypo\u002Fhyperthyroidism or other endocrinopathies that are well controlled with hormone replacement\n3. Subject has undergone a major surgery (excluding minor procedures e.g., placement of vascular access) \\\u003C2 months prior to administration of PRTH-101.\n4. Subject has received radiation therapy \\\u003C28 days prior to administration of PRTH-101.\n\n   a. Exception: limited (e.g., pain palliation) radiation therapy is allowed prior to and during study treatment as long as there are no acute toxicities, and the subject has measurable disease outside the radiation field.\n5. Subject has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem-cell transplantation, at any time.\n6. Subject has a diagnosis of immunodeficiency, either primary or acquired.\n7. Subject has received treatment with systemic steroids or any other form of immunosuppressive therapy within 14 days prior to administration of PRTH-101.\n\n   a. Exception: inhaled or topical (to include mouthwash) steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease.\n8. Subject has an active or prior history of autoimmune disease requiring immunosuppressive therapy. Exceptions can be made in discussion with the medical monitor.\n9. Subject has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins (e.g., soluble receptors or other Fc fusion proteins), or IV immunoglobulin preparations; prior history of human antihuman antibody response; known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.\n10. Subject has Central Nervous System (CNS) tumor involvement not definitively treated with surgery or radiation that is active (including evidence of cerebral edema by MRI, or progression from prior imaging study, or has had any requirement for steroids, or clinical symptoms of\u002Ffrom CNS metastases within 28 days prior to study treatment.\n11. Subject has leptomeningeal carcinomatosis, regardless of treatment history.\n12. Subject has current second malignancy at other sites (exceptions: nonmelanomatous skin cancer, adequately treated in situ carcinoma \\[e.g., cervical\\], or indolent prostate cancer under observation). A history of other malignancies is allowed as long as subject has been free of recurrence for ≥2 years, or if the subject has been treated with curative intent within the past 2 years and, in the opinion of the Investigator, is unlikely to have a recurrence.\n13. Subject has active and clinically significant bacterial, fungal, or viral infection, including known Hepatitis A, B, or C or HIV (testing not required).\n14. Subject has received live vaccines within the past 30 days (inactivated vaccines are allowed; seasonal vaccines should be up to date \\>30 days prior to administration of PRTH-101).\n15. Women who are pregnant or breastfeeding.\n16. History of any of the following ≤6 months before first dose:\n\n    a. Congestive heart failure New York Heart Association Grade III or IV b. Unstable angina c. Myocardial infarction d. Unstable symptomatic ischemic heart disease e. Uncontrolled hypertension despite appropriate medical therapy f. Ongoing symptomatic cardiac arrhythmias of \\> Grade 2 g. Symptomatic cerebrovascular events, or any other serious cardiac condition (e.g., pericardial effusion or restrictive cardiomyopathy); chronic atrial fibrillation on stable anticoagulant therapy is allowed.\n17. Subject has any contraindications to the imaging assessments or other study procedures that subjects will be undergoing.\n18. Subject has any medical or social condition that, in the opinion of the Investigator, might place a subject at increased risk, affect compliance, or confound safety or other clinical study data interpretation.",{"count":225,"type":20},270,[23],"The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.",[32,229,230],"Non Small Cell Lung Cancer","NSCLC",[229,230],"2026-02-19",{"date":234,"type":51},"2026-02-23",{"date":236,"type":51},"2023-03-03",{"date":238,"type":20},"2027-09-30",{"name":240,"class":58},"Incendia Therapeutics",11,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":21,"phases":251,"briefSummary":252,"conditions":253,"keywords":254,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":278},"100576183","phase-1-safety-and-tolerability-of-iph4502-in-patients-with-advanced-solid-tumors-100576183","NCT06781983","Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors","A Phase 1, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of IPH4502 as a Single Agent in Advanced Solid Tumors","Main Inclusion Criteria:\n\n* Histologically confirmed, unresectable, locally advanced or metastatic solid tumors that are known to express Nectin-4\n* Prior systemic treatment for locally advanced or metastatic disease, yet no therapy with demonstrated clinical benefit for the tumor type is available.\n* Measurable disease according to RECIST 1.1.\n* Archival tumor tissue obtained within 4 months of screening and since the last anticancer therapy prior to the study or agree to undergo a tumor biopsy at baseline.\n* Adequate organ function and hematological function.\n\nMain Exclusion Criteria:\n\n* Known or suspected brain metastases.\n* Participants with an active infection, Any other infection requiring systemic treatment or latent infection.\n* Participants with clinically significant comorbidity(s).\n* History of treatment for, or suspicion or confirmed interstitial lung disease (ILD) at baseline.\n* Condition being treated with systemic corticosteroids or immunosuppressive therapy during IPH4502 treatment.\n* Thromboembolic event requiring anticoagulation therapy ≤14 days prior to the first dose of IPH4502.\n* Clinically significant cardiovascular disease and\u002For cardiac repolarization abnormality.\n* Participants with symptomatic heart failure, Acute coronary syndromes\n* Participant is receiving or has received anticancer therapy prior to enrolment that may have impact on the assessment of IPH4502.\n* Major surgery ≤28 days and minor surgery ≤7 days prior to first dose of IPH4502 or 6 months for coronary artery bypass surgery.\n* Concomitant medications or vaccines : Live-attenuated vaccines ≤ 6 weeks prior to first dose of IPH4502; systemic corticosteroids or other immunosuppressive agents within 14 days prior to the first dose of IPH4502; systemic use of moderate or strong CYP 3A4 inhibitors; systemic use of moderate or strong CYP 3A4 inducers.",{"count":250,"type":20},145,[23],"This is a first-in-human, open-label, multicenter, Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of IPH4502 and to determine the recommended Phase 2 dose (RP2D) in advanced solid tumors that are known to express Nectin-4",[32],[255,256,257,258,259,260,261,262,263,264,265,26,266,267,268],"Exatecan","Topo-Isomerase I inhibitor","Squamous cell carcinoma of the head and neck","Esophageal squamous cell carcinoma","Triple negative breast cancer","Non-small cell lung cancer","Gastro-esophageal junction and gastric cancer","Colorectal carcinoma","Ovarian carcinoma","Prostate cancer","Cervical cancer","Urothelial carcinoma","Antibody-drug conjugates","ADC","2026-01-05",{"date":271,"type":51},"2026-01-07",{"date":273,"type":51},"2025-01-24",{"date":275,"type":20},"2029-04",{"name":277,"class":58},"Innate Pharma",7,{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":21,"phases":289,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":300,"locationsCount":302},"100512794","phase-1-study-to-assess-the-safety-tolerability-and-blood-concentration-of-pmc-309-100512794","NCT05957081","Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309","A Phase 1a\u002F1b, First-in-Human, Open Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of PMC-309 (Anti-VISTA), as Monotherapy and Combined With Pembrolizumab, in Patients With Advanced or Metastatic Solid Tumors","MarkV-01","Inclusion Criteria:\n\nTo be eligible for this study, a participant must meet ALL of the following inclusion criteria:\n\n1. The participant voluntarily signs an informed consent form (ICF) indicating they understand the purpose and procedures required for the study and are willing to participate in the study.\n2. Are at least 18 years of age.\n3. Are diagnosed with advanced or metastatic solid tumors (non-lymphoma) by histology or pathology that is metastatic or unresectable and considered relapsed and\u002For refractory to prior therapy.\n\n   Definition of anti-PD-1\u002FL1 refractory participant:\n\n   Participants must have progressed on treatment with an anti-PD1\u002FL1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria:\n   1. Has received at least 2 doses of an approved anti-PD-1\u002FL1 mAb.\n   2. Has demonstrated disease progression (PD) after PD-1\u002FL1 as defined by RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented PD, in the absence of rapid clinical progression.\n   3. PD has been documented within 12 weeks from the last dose of anti-PD-1\u002FL1 mAb.\n\n   i. PD is determined according to iRECIST v1.1. ii. This determination is made by the PI (or designee). Once PD is confirmed, the initial date of PD documentation will be considered the date of disease progression\n4. Have measurable disease per RECIST v1.1 documented by computerized tomography scan (CT scan) and\u002For magnetic resonance imaging (MRI), measurable at Baseline. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n5. Have an ECOG performance status of 0 or 1.\n6. Can satisfy the following criteria in hematologic, renal, and hepatic function tests performed within 7 days prior to screening:\n\n   1. Hematologic tests:\n\n      * ANC more than and equal to 1.5 × 109 per L.\n      * Platelets more than and equal to 100 × 109 per L.\n      * Hemoglobin more than and equal to 9.0 g per dL or more than and equal to 5.6 mmol per L.\n\n      Note: Criteria must be met without packed red blood cell (pRBC) transfusion within the prior 2 weeks. Participants can be on a stable dose of erythropoietin (more than equal to approximately 3 months).\n   2. Blood coagulation tests:\n\n      * Prothrombin time less than and equal to 1.5 × upper limit of normal (ULN).\n      * Activated partial thromboplastin time less than and equal to 1.5 × ULN.\n   3. Hepatic function tests:\n\n      * Total bilirubin less than and equal to 1.5 × ULN or direct bilirubin less than and equal to ULN for participants with total bilirubin levels more than and equal to 1.5 × ULN.\n      * Aspartate aminotransferase or alanine aminotransferase less than and equal to 2.5 × ULN (less than and equal to 5× ULN in case of liver metastasis).\n   4. Renal function test:\n\n      * less than and equal to 1.5 × ULN or creatinine clearance more than and equal to 30 mL\u002Fmin for participant with creatinine levels above 1.5 × institutional ULN.\n7. Are willing and able to adhere to the prohibitions and restrictions as specified in the study protocol.\n8. Eligible participants (male and female) of childbearing potential must agree to use reliable contraception (hormone, barrier method, or abstinence) from Screening (Day -1) until at least 120 days after administration of the last dose of the IP.\n9. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at Screening (Day -1) and be willing to have additional pregnancy tests as required throughout the study.\n10. Human immunodeficiency virus (HIV) infected participants must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection\u002Fdisease defined as:\n\n    1. Participants on ART must have a CD4+ T-cell count 350 cells\u002Fmm3 at time of Screening.\n    2. Participants on ART must have achieved and maintained virologic suppression defined as confirmed by HIV RNA level below 50 copies\u002FmL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of Screening and for at least 12 weeks prior to Screening.\n    3. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to study entry (Day 1).\n\nExclusion Criteria:\n\nA participant who meets ANY of the following exclusion criteria must be excluded from the study:\n\n1. Has received treatment with a VISTA targeting agent.\n2. Has a history of positive testing for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-hepatitis C virus) or other clinically active liver disease, or positive testing at Screening for HBsAg or anti- hepatitis C virus.\n3. HIV-infected participants with a history of Kaposi sarcoma and\u002For Multicentric Castleman Disease.\n4. Has a medical condition which, in the opinion of the PI (or designee), places the participant at an unacceptably high risk for toxicity.\n5. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n6. Is currently participating in or has participated in a study of an investigational agent or have received anticancer immunotherapy within 4 weeks prior to the first dose of IP.\n7. Has an active autoimmune disease with a history of flares requiring immunosuppressant medications within the past 6 months or that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n8. History of known or suspected seizure disorder.\n9. Has oxygen-dependent chronic disease.\n10. Serious Grade 4 venous thromboembolic event including pulmonary embolism.\n11. Participant is receiving therapeutic anticoagulants.\n12. Has had an allogeneic tissue\u002Fsolid organ transplant.\n13. Major surgery (eg, requiring general anesthesia) within 4 weeks before the planned first dose of the IP, or not fully recovered from prior surgery, or has surgery planned during the time the participant is expected to participate in the study or within 4 weeks after the last dose of IP.\n14. Fertility exclusions:\n\n    1. Participant is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 120 days after the last dose of IP; WOCBP must have a negative pregnancy status confirmed by urine pregnancy test at Screening and within 72 hours of first dose of the IP. (If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.)\n    2. Participant is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of the IP.\n    3. Male participants must also refrain from sperm donation during the treatment period and for 5 terminal half-lives (of PMC-309) plus an additional 90 days (a spermatogenesis cycle).\n\n    Note: The half-life of PMC-309 is 47 hours.\n15. Vaccinated with a live vaccine within 30 days (with the exception of the annual inactivated influenza vaccine) prior to the first dose of the IP.\n16. Received COVID-19 vaccine within 7 days of the first IP administration.\n17. Any medical condition for which, in the opinion of the PI or designee, participation would not be in the best interest of the participant (eg, compromise the well-being of the participant) or that could prevent, limit, or confound the protocol specified assessments.\n18. Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension; poorly controlled diabetes; ongoing active infection requiring antibiotics or acute infectious illness (including suspected viral infection); symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia considered to increase risk for the participant by the PI (or designee); or active psychiatric disorder (schizophrenia, major depressive disorder, bipolar disorder, treated depression with ongoing antidepressant medication etc.) that would limit compliance with study requirements.\n19. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (at a dose exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of IP.\n20. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression for at least 4 weeks by repeat imaging \\[note that the repeat imaging should be performed during Screening\\], clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of IP).\n21. Prior allogeneic organ or bone marrow transplant.\n22. Participant has had prior therapy meeting the following:\n\n    1. Prior T-cell receptor-modified or chimeric antigen receptor T-cell (CART) therapy.\n    2. Other anticancer therapy, including chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 4 weeks prior to the first dose of IP.\n    3. Has received prior radiotherapy (excluding limited palliative radiation) within 2 weeks of start of IP or has a history of radiation pneumonitis.\n    4. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (less than and equal to 2 weeks of radiotherapy) to non-CNS disease.\n    5. Except for hearing loss, alopecia and pigmentation, all toxicity caused by previous anti-tumor therapy has recovered to Grade 1 or less.\n23. Participant received prior therapy with an anti-PD-1 or anti-PD-L1 mAb or with an agent targeting stimulatory or co-inhibitory T-cell receptors and was discontinued from that treatment due to a Grade 3 or higher immune related AE.\n24. Participant has an active autoimmune disease that required systemic treatment in the past.\n25. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease.\n26. Class III or IV heart failure by New York Heart Association (NYHA) classification.\n27. History of abdominal fistula or gastrointestinal perforation within 6 months prior to start of IP administration.\n28. History of serious gastrointestinal hemorrhage within 6 months prior to start of IP administration.\n29. History of hypertensive crisis or hypertensive encephalopathy.\n30. History of posterior reversible encephalopathy syndrome.\n31. Social situation that would limit compliance with study requirements.\n32. A diagnosis of immunodeficiency or is receiving chronic systemic corticosteroids at a dose that exceeds 10 mg daily of prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior the first dose of the IP. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.",{"count":288,"type":20},67,[23],"This is a Phase 1a\u002F1b, first-in-human (FIH), open label study to evaluate the safety, tolerability, and pharmacokinetics (PK) of PMC-309, a mAb against the human VISTA ligand, in participants with advanced or metastatic solid tumors administered as a monotherapy and in combination with pembrolizumab.",[32],[293],"PMC-309 and Anti-VISTA","2025-12-23",{"date":296,"type":51},"2025-12-30",{"date":298,"type":51},"2024-01-03",{"date":104,"type":20},{"name":301,"class":58},"PharmAbcine",4,{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":21,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":278},"100571727","phase-1-dose-escalation-and-expansion-study-of-hm16390-alone-or-with-pembrolizumab-in-advanced-or-metastatic-solid-tumors-100571727","NCT06724016","Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors","A Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study of HM16390, as a Single Agent and in Combination With Pembrolizumab, in Patients With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Have a histologically and\u002For cytologically confirmed advanced or metastatic solid tumor and have failed or are intolerant to standard therapy with clinical benefit.\n* Patients in the Dose-Escalation Part must have evaluable or measurable disease at baseline and the patients for Dose-Ranging and Dose-Expansion Part must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before allocation or randomization.\n* Age of 18 years or older (or country's legal age of majority if the legal age was \\>18 years)\n* Adequate renal function.\n* Adequate hematologic function.\n* Adequate liver function.\n\nKey Exclusion Criteria:\n\n* Received prior treatment with agent targeting the IL-2, IL-7, or IL-15 receptors, or related to mode of action of HM16390.\n* Known active CNS metastases and\u002For carcinomatous meningitis.\n* History of severe toxicities associated with a prior immunotherapy.\n* Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 per NCI-CTCAE version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment.\n* Has ongoing or suspected autoimmune disease.\n* Known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, immunocompromised patients.\n* History of chronic liver disease or evidence of hepatic cirrhosis.",{"count":311,"type":20},292,[23],"This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of HM16390, as a single agent and in combination with pembrolizumab to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors.\n\nDose-Escalation Part is planned to establish the MTD or RDs for the randomized Dose-Ranging Part. Based on the results of the Dose-Escalation Part, additional eligible subjects will be randomized 1:1 into each dose level. After a comprehensive review of available data from both Dose-Escalation Part and Dose-Ranging Part, the RDEs to be tested in the Dose-Expansion Part are determined. Dose-Expansion Part is designed to assess the potential efficacy of HM16390 as a single agent and in combination with pembrolizumab when administered at the RDEs to subjects in indication-specific expansion cohorts.",[32],"2025-12-09",{"date":317,"type":51},"2025-12-17",{"date":319,"type":51},"2024-12-11",{"date":321,"type":20},"2031-07",{"name":215,"class":58},{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":21,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":342,"locationsCount":107},"100575644","phase-1-a-phase-1-study-of-lncb74-in-advanced-solid-tumors-100575644","NCT06774963","A Phase 1 Study of LNCB74 in Advanced Solid Tumors","A Phase 1, Open-label, Dose Escalation and Dose Expansion Study for LNCB74, a B7-H4 Targeted Antibody Drug Conjugate, as Monotherapy in Participants With Advanced Solid Tumors","LNCB74-01","Inclusion Criteria:\n\n1. The participant provides written informed consent\n2. ≥ 18 years of age on day of signing informed consent.\n3. Participant with histologically or cytologically confirmed diagnosis of advanced unresectable and\u002For metastatic solid tumors\n4. A male participant must agree to use contraception and refrain from sperm donation or expecting to father a child\n5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential\n6. Have measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology\n7. Able to provide tumor tissue sample.\n8. Willing to undergo fresh tumor biopsy at Screening and On-treatment if archival tissue not available\n9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n10. Life expectancy greater than or equal to 12 weeks as judged by the Investigator.\n11. Have adequate organ function\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive serum pregnancy test (within 72 hours) prior to treatment.\n2. Has received prior investigational agents within 4 weeks prior to treatment.\n3. Has received anti-cancer chemotherapy (Immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy within 2 weeks prior to treatment.\n4. Has received antibody-based anti-cancer therapy within 4 weeks prior to treatment.\n5. Has received targeted agents and small molecules within 2 weeks or 5 half-lives, whichever is longer.\n6. Has received prior platinum-based chemotherapy and progressed within 4 weeks of initiating therapy (platinum-refractory disease)\n7. Has received an ADC with MMAE payload.\n8. Has received prior radiotherapy within 2 weeks of start of study treatment for focal radiation or within 4 weeks for wide-field radiotherapy\n9. Has received G-CSF or GM-CSF within 7 days prior to start of study treatment.\n10. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.\n11. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n12. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n13. Has known active CNS metastases and\u002For carcinomatous meningitis\n14. Has severe hypersensitivity (≥ Grade 3), known allergy or reaction LNCB74 or any of its excipients.\n15. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease.\n16. Has active ≥Grade 2 sensory or motor neuropathy.\n17. Has active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy or any clinically significant corneal disease.\n18. Has an active infection requiring systemic therapy.\n19. Any major surgery within 4 weeks of study drug administration.\n20. Toxicity (except for alopecia) related to prior anti-cancer therapy and\u002For surgery, unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible.\n21. Prior organ or tissue allograft.\n22. Uncontrolled or significant cardiovascular disease\n23. Participants with serious or uncontrolled medical disorders.\n24. Participants who are on total parenteral nutrition (TPN)\n25. Participants with history of bowel obstruction within one month of screening\n26. Participants with history of significant ascites requiring paracentesis within 2 weeks of screening\n27. Has a known history of human immunodeficiency virus (HIV) infection with an acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within the last year, or a current CD4 count \\\u003C350 cells\u002Fµl\n28. Has known active Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection\n29. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study\n30. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study",{"count":250,"type":20},[23],"This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and \u002F or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors.",[173,172,181,335,29,32],"Biliary Tract Cancer","2025-12-08",{"date":338,"type":51},"2025-12-16",{"date":340,"type":51},"2025-01-07",{"date":192,"type":20},{"name":343,"class":58},"NextCure, Inc.",{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":21,"phases":353,"briefSummary":354,"conditions":355,"keywords":356,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":371},"100573930","phase-1-to-evaluate-the-safety-tolerability-pharmacokinetics-and-antitumor-activity-of-day301-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100573930","NCT06752681","To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase 1, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of the PTK7-Targeted Antibody-drug Conjugate DAY301 in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors of the following histologies:\n* Ovarian cancer\n* Esophageal squamous cell carcinoma\n* Triple-negative breast cancer\n* Non-small cell lung cancer\n* Small cell lung cancer\n* Head and neck squamous cell carcinoma\n* Gastric\u002Fgastroesophageal junction adenocarcinoma\n* Cervical squamous cell carcinoma\n* Endometrial cancers\n\n(Participants must have been previously treated with standard of care systemic therapy, or for whom no standard therapy is available).\n\n* Availability of tumor tissue sample (either an archival specimen or a fresh biopsy) at screening\n* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Prior use of PTK7 targeting treatment (Phase 1a) or prior use of PTK7 targeting treatments and\u002For topoisomerase 1 (TOP1) inhibitor-based antibody-drug conjugate (ADC) (Phase 1b).\n* Phase 1b disease-specific exclusion criteria:\n\n  1. Cohort 1: Neuroendocrine tumors or endometrial sarcoma (eg, stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas)\n  2. Cohort 2: Ovarian cancer that progressed \\>6 months after the last dose of platinum-based chemotherapy (platinum-sensitive disease), or disease that did not respond (partial response \\[PR\\] or complete response \\[CR\\]) to or progressed ≤91 days after the last dose of first-line platinum-based chemotherapy (primary platinum-refractory disease)\n  3. Cohort 3: nasopharyngeal primary tumors.\n* History of small bowel obstruction requiring hospitalization within 3 months prior to the first dose of study treatment.\n* Ascites requiring frequent paracentesis (more often than approximately every 4 weeks) for symptomatic management, or new onset within 4 weeks prior to the first dose of study treatment. Patients with an indwelling catheter may be considered eligible, after consultation with the medical monitor.\n* Active or progressing brain metastases or evidence of leptomeningeal disease.\n* Persistent toxicities from previous systemic antineoplastic treatments of Grade \\>1, excluding alopecia and vitiligo.\n* Systemic antineoplastic therapy within five half-lives or 4 weeks, whichever is shorter, prior to first dose of study treatment, including investigational agents.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":352,"type":20},254,[23],"This is a Phase 1a\u002F1b, open-label, dose escalation and expansion study to evaluate the safety and anti-tumor activity of DAY301, a PTK7-directed antibody-drug conjugate in participants with advanced or metastatic solid tumors. The study comprises of 2 phases: Phase 1a dose escalation where participants will be administered DAY301 at escalating dose levels to assess safety and tolerability, and to determine the maximum tolerated dose (MTD) and\u002For the recommended dose (RD); In Phase 1b dose expansion, DAY301 will be evaluated in dose expansion cohorts.",[32],[357,358,359,360,361],"Advanced or metastatic solid tumors","Dose Escalation","Dose Expansion","DAY301","PTK7-Targeted Antibody-drug Conjugate","2025-10-08",{"date":364,"type":51},"2025-10-10",{"date":366,"type":51},"2024-11-18",{"date":368,"type":20},"2028-12",{"name":370,"class":58},"Day One Biopharmaceuticals, Inc.",12,{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":21,"phases":381,"briefSummary":382,"conditions":383,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":390,"locationsCount":392},"100499630","phase-1-dcsz11-as-a-monotherapy-and-in-combination-in-patients-with-advanced-or-metastatic-solid-tumors-100499630","NCT05785754","DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors","A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors","Selected Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age.\n2. Be willing and able to provide written informed consent for the study.\n3. Patients in Phase 1a must have a histologically or cytologically documented, advanced (metastatic and\u002For unresectable) solid tumor that has progressed on or after standard therapy (relapsed\u002Frefractory patients; patients must have failed at least one prior line of therapy) or for whom there is no effective standard therapy based on the Investigator's judgment.\n\n   Note: Patients with glioblastoma (GBM) or other central nervous system(CNS) tumors may participate if they are on stable or decreasing corticosteroid levels not exceeding 2 mg\u002Fday dexamethasone (or equivalent doses of other corticosteroids) within 7 days of the first dose of study drug or do not require corticosteroids.\n\n   Note: For patients who are intolerant to or refuse standard-of-care therapy for recurrent disease, reasons must be documented.\n4. Patients in Phase 1b Dose Optimization\u002FExpansion must have one of the following:\n\n   1. Non-squamous NSCLC for which prior standard first-line treatment containing an anti-PD-(1\u002FL1) checkpoint inhibitor alone or in combination has failed and that has progressed to no more than 2 prior systemic therapies. Patients must not have presented with disease progression during the first 3 months of treatment with first line anti-PD-(1\u002FL1)-containing therapy. Patients must have had documented disease progression per RECIST 1.1 within 12 weeks from the last dose of anti-PD-1\u002FL1 mAb to be considered to have failed an anti-PD-(1\u002FL1) mAb containing therapy. The initial evidence of disease progression to anti-PD-1\u002FL1 mAb containing therapy needs to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression.\n\n      Note: Patients with known driver mutations\u002Fgenomic aberrations (i.e., EGFR, B-Raf proto-oncogene mutation V600E \\[BRAF V600E\\], and ROS proto-oncogene 1 \\[ROS1\\] sensitizing mutations, neurotrophic receptor tyrosine kinase \\[NRTK\\] gene fusions, and ALK rearrangements) are not eligible.\n\n      Note: Patients with rapid clinical progression are excluded from participation.\n   2. Immunotherapy-naïve microsatellite stable-CRC (MSS-CRC) that failed or was intolerant to ≥ 2 lines of therapy and that progressed on\u002Fafter no more than 4 lines of therapy.\n\n   Note: Patients must have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing regimens if indicated. Patients eligible for treatment with an approved and available targeted therapy must have been offered such therapy prior to enrollment. Adjuvant chemotherapy will be considered a prior line of therapy if the patient progressed while on or within 6 months of completing adjuvant treatment.\n5. Patients in Phase 1b Standard-of-Care Combination Lead-in\u002FExpansions must have one of the following:\n\n   1. Histologically confirmed, anthracycline naïve, metastatic or locally advanced, unresectable soft-tissue sarcoma for which doxorubicin monotherapy is indicated. Note: Ewing sarcoma, gastrointestinal stromal tumor (GIST), and Kaposi sarcoma are excluded.\n   2. Histologically confirmed, metastatic or advanced, unresectable uveal melanoma that are eligible for treatment with tebentafusp monotherapy. Patients should not have received more than 4 doses of tebentafusp at the target dose level of 68 mcg.\n6. Patients must have a lesion not previously irradiated that can be biopsied with acceptable clinical risk and agree to have a fresh biopsy at Screening and on treatment; except patients with GBM or other CNS tumors. Every effort must be made to take the second biopsy from the same lesion of the biopsy at Screening.\n7. Patients must have at least 1 measurable lesion according to RECIST 1.1; except for patients enrolled in monotherapy dose levels 1 and 2.\n\n   1. A lesion in a previously irradiated area is eligible to be considered as a measurable disease as long as there is objective evidence of progression of the lesion before study enrollment.\n   2. Patients must have at least 1 measurable lesion for inclusion that will not undergo biopsy.\n   3. Patients with GBM must meet the RANO criteria of measurable disease for the post-gadolinium primary T1WI.\n8. Patients with previously treated CNS metastases may participate provided that:\n\n   1. They are stable (i.e., without evidence of progression by magnetic resonance imaging \\[MRI\\]) for ≥ 4 weeks prior to the first dose of study drug), and\n   2. All neurologic symptoms have returned to baseline, and\n   3. For patients enrolled in expansion cohorts, have not required steroid treatment for at least 14 days before the first dose of study intervention Patients with signs or symptoms suggestive of CNS metastases, must have brain imaging performed to confirm the absence of detectable CNS disease within 2 weeks prior to the first dose of study drug.\n\n   Note: This criterion does not apply to patients with GBM or other CNS tumors.\n9. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. Patients enrolled in expansion cohorts must have an ECOG performance status of 0 or 1.\n10. Adequate organ function and bone marrow reserve as indicated by the following laboratory assessments performed within 10 days prior to the first dose of study drug:\n\n    1. Bone marrow function: absolute neutrophil count (ANC) ≥ 1000\u002FµL, ANC ≥ 1500\u002FµL in expansions; hemoglobin ≥ 9 g\u002FdL (criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks) ; platelet count ≥ 75,000\u002FµL, platelet count ≥ 100,000\u002FµL in expansions.\n    2. Hepatic function: Total serum bilirubin ≤ 1.5 × the upper limit of normal (ULN) or direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 x ULN; serum aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT), ≤ 2.5 × ULN (≤ 5 × ULN in the presence of hepatic metastases).\n\n       Note: Patients with inherited disorders of bilirubin metabolism should be discussed with the Sponsor.\n    3. Renal function: Creatinine clearance ≥ 30 mL\u002Fminute based on Cockcroft-Gault estimation.\n    4. Coagulation profile: Prothrombin time (PT)-international normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Patients on a stable, maintenance regimen of anticoagulant therapy for at least 30 days prior to the first dose of study drug may have PT\u002FINR measurements \\> 1.5 × ULN if, in the opinion of the Investigator, the patient is suitable for the study. An adequate rationale must be provided to the Sponsor prior to enrollment.\n11. Have recovered to Grade 1 or baseline from all toxicity associated with previous therapy or have the toxicity established as sequela.\n\n    Note: Neuropathy and\u002For hearing impairment ≤Grade 2, any grade alopecia, or autoimmune endocrinopathies with stable replacement therapy are permitted.\n12. Patients receiving a combination with standard-of-care must meet established treatment criteria for the respective standard-of-care agent(s).\n13. Patients with human immunodeficiency virus (HIV) must have well controlled disease on antiretroviral therapy (ART), defined as:\n\n    1. Patients on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening.\n    2. Patients on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.\n    3. Patients on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study.\n    4. Patients must not have had any AIDS-defining opportunistic infections within the past 12 months or any history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n14. Female patients must agree to not breastfeed through 5 months after the last dose of study drug and must meet 1 of the following:\n\n    1. Postmenopausal for at least 1 year before the screening visit, or\n    2. Surgically sterile, or\n    3. Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception at the same time, from the time of signing of the ICF through 5 months after the last dose of study, or\n    4. Agree to practice true abstinence during the entire study treatment period and through 5 months after the last dose of study drug, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.\n15. Male patients, even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following:\n\n    1. Agree to practice effective barrier contraception from the time of signing of the ICF through 2 months after the last dose of DCSZ11, or\n    2. Agree to practice true abstinence from the time of signing of the ICF through 2 months after the last dose of study drug, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.\n16. Must be willing and able to comply with clinic visits and procedures outlined in the study protocol.\n\nCriteria for Exclusion:\n\n1. Received systemic anticancer treatments or investigational products within 28 days before the first dose of study drug or 5 half-lives, whichever is shorter.\n\n   Note: Low-dose steroids (oral prednisone ≤10 mg per day or equivalent), hormonal therapy for prostate cancer or breast cancer (as adjuvant treatment), and treatment with bisphosphonates and receptor activator of nuclear factor kappa-Β ligand (RANKL) inhibitors are allowed.\n2. Received extended field radiotherapy ≤4 weeks before the start of treatment (≤7 days for limited field radiation for palliation outside the chest or brain) or has radiation related toxicities requiring corticosteroid treatment.\n3. Patients with second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the patient is not on active anticancer therapy. These patients must be discussed with the Sponsor prior to enrollment.\n4. Patients with known active CNS metastases and or carcinomatous meningitis.\n5. Systemic arterial thrombotic or embolic events, such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 3 months prior to the first dose of study drug\n6. Systemic venous thrombotic events (e.g., deep vein thrombosis) or pulmonary arterial events (e.g., pulmonary embolism) within 1 month prior to the first dose of study drug. Patients with venous thrombotic events prior to the first dose of study drug on stable anticoagulation therapy are eligible.\n7. Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n8. Major surgery within 4 weeks and minor surgery within 2 weeks of the first dose of study drug; following surgeries, all surgical wounds must be healed and free of infection or dehiscence. Patients must have recovered and not have ongoing surgical complications.\n9. Marked proteinuria ≥ 2 g\u002F24 hours and\u002For nephrotic syndrome. Patients with proteinuria 2+ or greater urine dipstick reading should undergo further assessment, e.g., a 24-hour urine collection.\n10. Known allergy or hypersensitivity to any component of the study drugs or, for patients receiving the imaging agent, any component of the imaging agent.\n11. For patients receiving a combination with pembrolizumab:\n\n    1. Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.\n    2. Severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n    3. Autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years. Hormone therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered an excluded form of systemic treatment of an autoimmune disease.\n    4. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.\n    5. History of radiation therapy to the lung that is \\>30 Gy within 6 months of the first dose of study treatment\n    6. History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n    7. History of allogeneic tissue or solid organ transplant.\n12. Receipt of any live or live-attenuated vaccine within 4 weeks of initiation of study treatment. Administration of killed vaccines is allowed.\n13. Has active infection requiring systemic therapy.\n14. Patients that are hepatitis B virus surface antigen (HBsAg) seropositive and with detectable hepatitis B virus (HBV) viral load. Note: Patients with positive HBsAg can been enrolled if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to initiation of study treatment. Patients should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.\n15. Patients with history of hepatitis C virus (HCV) infection and detectable HCV viral load at screening. Note: Patients must have completed curative antiviral therapy at least 4 weeks prior to initiation of study treatment.\n16. History of any of the following ≤6 months before first dose: congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias \\>Grade 2, or any other serious cardiac condition (e.g., pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed.\n17. History or current evidence of any condition, therapy, laboratory abnormality, psychiatric illness, social circumstances, or other circumstance that might compromise the ability to provide informed consent, confound the results of the study, or interfere with the patient's ability to cooperate with the requirements of the study, such that it is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n18. Female patients who are pregnant or lactating and breastfeeding.",{"count":380,"type":20},320,[23],"This is a multicenter, open-label, Phase 1 study to assess the effects of DCSZ11 as a monotherapy and in combination in patients with advanced or metastatic solid tumors. The study consists of an Escalation Phase (Phase 1a) and a Dose Expansion\u002FOptimization Phase (Phase 1b).",[32],"2025-06-23",{"date":386,"type":51},"2025-06-26",{"date":388,"type":51},"2023-06-28",{"date":192,"type":20},{"name":391,"class":58},"DynamiCure Biotechnology",35,{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":21,"phases":402,"briefSummary":403,"conditions":404,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":216},"100485213","phase-1-dose-escalation-and-expansion-study-of-hm97662-in-advanced-or-metastatic-solid-tumors-100485213","NCT05598151","Dose Escalation and Expansion Study of HM97662 in Advanced or Metastatic Solid Tumors","A Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study of HM97662 as a Single Agent in Patients With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically and\u002For cytologically confirmed advanced or metastatic solid tumor who have failed\u002Fare intolerant to standard therapy.\n* Patients for dose-escalation part must have evaluable or measurable disease at baseline and the patients for randomized dose-ranging and dose-expansion part must have at least one measurable lesion at baseline by CT or MRI per Response Evaluation Criteria in Solid Tumor (RECIST v1.1).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 3 months before starting HM97662.\n* Adequate renal function.\n* Adequate hematologic function.\n* Adequate liver function.\n* Males or females aged ≥ 18 years (or country's legal age of majority if the legal age was \\> 18 years) at the time of informed consent.\n* For Dose-Ranging Part, documentation of an alteration in at least one of the genes of the SWI\u002FSNF complex in tumor tissue (archival or newly obtained).\n\nExclusion Criteria:\n\n* Prior exposure to valemetostat or other EZH1\u002F2 dual inhibitor.\n* Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.\n* Patients currently taking medications that are known strong CYP3A inhibitors and strong or moderate CYP3A inducers.\n* Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 per CTCAE version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment.\n* Major surgery within 4 weeks before the first dose of study drug treatment in Cycle 1.\n* Females who are pregnant or breastfeeding.\n* Patients who have undergone an organ transplant.",{"count":401,"type":20},170,[23],"This is a Phase1 study to assess the safety, PK, PD and efficacy of HM97662, EZH1\u002F2 dual inhibitor, in solid tumors. The study is comprised of Dose-Escalation Part followed by randomized Dose-Ranging Part and Dose-Expansion Part. Dose-Escalation Part is planned with a 3+3 Dose-Escalation design and is to establish the MTD or RD for randomized Dose-Ranging Part. Dose-Ranging Part is designed mainly to further evaluate safety and preliminary efficacy of HM97662 monotherapy in subjects with specific genomic alterations to more precisely determine the potential RP2D that are to be tested in a Dose-Expansion Part. Dose-Expansion Part is designed to assess the potential efficacy of HM97662 monotherapy when administered at the RP2D to subjects in indication-specific expansion cohorts.",[32],"2025-04-28",{"date":407,"type":51},"2025-04-30",{"date":409,"type":51},"2023-01-11",{"date":411,"type":20},"2028-06",{"name":215,"class":58},{"id":414,"slug":415,"hasResults":11,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":21,"phases":422,"briefSummary":423,"conditions":424,"keywords":425,"overallStatus":431,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":4},"100546022","phase-1-a-study-of-chs-1000-in-participants-with-advanced-or-metastatic-solid-tumors-100546022","NCT06389526","A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors","A Phase 1, Multicenter, Open-Label Study of CHS-1000 as a Single Agent and in Combination With Toripalimab-tpzi in Participants With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Histopathologically or cytologically confirmed diagnosis of advanced or metastatic unresectable solid tumors (excluding glioblastoma multiforme (GBM)) by tissue biopsy or archival tumor specimen. Unresectable tumors are defined as tumors with lesions in which clear surgical excision margins cannot be obtained, in close proximity to major blood vessels, not with oligometastatic and with advanced organ and lymph node (LN) involvement, and not leading to significant functional compromise as determined by surgical consult or Tumor Board.\n* Participants must have been previously treated or be ineligible for, or intolerant of, available approved standard therapies known to confer clinical benefit (including immunotherapy), or for whom no effective standard therapy exists.\n* At least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the investigator.\n\nKey Exclusion Criteria:\n\n* Concurrent enrollment in another clinical study or participation in another clinical study within 28 days prior to the 1st dose of CHS-1000, except for observational (noninterventional) studies or the follow-up period of an interventional study.\n* Current or prior use of systemic anticancer treatment, including but not limited to chemotherapy, immunotherapy, biologic treatment, hormone therapy, and targeted therapy, if within 8 weeks or 5 half-lives (whichever is shorter) for biologic therapies, or if within 28 days for most other anticancer therapies, prior to the 1st dose of CHS-1000.\n* Concurrent or prior radiotherapy within 28 days prior to the 1st dose of CHS-1000 or unresolved treatment-related radiation toxicity. Limited local radiotherapy for palliative intent (eg, to a single site of metastatic disease) is permitted within 28 days prior to the 1st dose of CHS-1000 provided that the participant has no evidence of or has recovered from any treatment-related radiation toxicity.\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.",{"count":421,"type":20},48,[23],"The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors.",[32],[426,427,428,429,430],"CHS-1000","Tumors","Toripalimab","ILT4","LILRB2","NOT_YET_RECRUITING","2024-09-17",{"date":434,"type":51},"2024-09-19",{"date":436,"type":20},"2025-02-15",{"date":438,"type":20},"2028-05-30",{"name":440,"class":58},"Coherus Oncology, Inc.",{"id":442,"slug":443,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":115,"enrollmentInfo":448,"targetDuration":4,"studyType":21,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":159},"100492569","phase-1-pan-t-booster-co-expressing-msln-car-t-cell-therapy-in-advancedmetastatic-solid-tumors-100492569","NCT05693844","Pan-T Booster Co-expressing MSLN CAR T Cell Therapy in Advanced\u002FMetastatic Solid Tumors","Phase I\u002FII Study of Pan-T Booster Co-expressing MSLN CAR T Cell Therapy in Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n* 1\\. Age from 18 to 75 years with estimated life expectancy \\>3 months.\n* 2\\. Histopathological confirmed advanced or metastatic solid tumors failed to at least first-line treatment or initially diagnosed advanced\u002Fmetastatic solid tumors that have no NCCN guideline recommended standard first-line therapy. Mesothelin antigen expression percentage \\>＝10%.\n* 3\\. Have at least one measurable target lesion.\n* 4\\. Fresh solid tumor samples or formalin-fixed paraffin embedded tumor archival samples within 6 months are necessary; Fresh tumor samples are preferred. Subjects are willing to accept tumor rebiopsy in the process of this study.\n* 5\\. Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to \\\u003C= grade 1 toxicity.\n* 6\\. Have an Eastern Cooperative Oncology Group performance status (ECOG) of 0 or 2 at the time of enrollment.\n* 7\\. Have adequate organ function, which should be confirmed within 2 weeks prior to the first dose of study drugs.\n* 8\\. Previous treatment with anti-PD-1\u002FPD-L1 antibodies are allowed.\n* 9\\. Ability to understand and sign a written informed consent document.\n* 10\\. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and up to 90 days after the last dose of the drug.\n\nExclusion Criteria:\n\n* 1\\. Active, known or suspected autoimmune diseases.\n* 2\\. Known brain metastases or active central nervous system (CNS). Subjects with CNS metastases who were treated with radiotherapy for at least 3 months prior to enrollment, have no central nervous symptoms and are off corticosteroids, are eligible for enrollment, but require a brain MRI screening.\n* 3\\. Subjects are being treated with either corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.\n* 4\\. History of severe hypersensitive reactions to other monoclonal antibodies.\n* 5\\. History of allergy or intolerance to study drug components.\n* 6\\. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.\n* 7\\. History or concurrent condition of interstitial lung disease of any grade or severely impaired pulmonary function.\n* 8\\. Uncontrolled intercurrent illness, including ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia) or psychiatric illness\u002Fsocial situations and any other illness that would limit compliance with study requirements and jeopardize the safety of the patient.\n* 9\\. History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).\n* 10\\. Pregnant or breast-feeding. Women of childbearing potential must have a pregnancy test performed within 7 days before the enrollment, and a negative result must be documented.\n* 11\\. Previous or concurrent cancer within 3 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\\].\n* 12\\. Vaccination within 30 days of study enrollment.\n* 13\\. Active bleeding or known hemorrhagic tendency.\n* 14\\. Subjects with unhealed surgical wounds for more than 30 days.\n* 15\\. Being participating any other trials or withdraw within 4 weeks.",{"count":85,"type":20},[23,71],"In preclinical study, investigators have demonstrated that the newly developed pan-T booster (harbouring CD40 agonist and one T cell costimulator agonist) co-expressing MSLN CAR T cell possess more powerful antitumor activity than previously reported MSLN-CAR T cells. In this clinical trial, enrolled patients receive an initial dose of pan-T booster co-expressing MSLN CAR T cells at 1×10\\^6 cells\u002Fkg based on the basic principle of dose escalation design, in order to evaluate the safety, feasibility, pharmacokinetics\u002Fpharmacodynamics, and efficacy of pan-T booster co-expressing MSLN CAR T cell in vivo.",[32],"2024-05-08",{"date":454,"type":51},"2024-05-10",{"date":456,"type":51},"2023-01-20",{"date":458,"type":20},"2026-12-31",{"name":460,"class":461},"Chinese PLA General Hospital","OTHER",{"id":463,"slug":464,"hasResults":11,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":21,"phases":471,"briefSummary":472,"conditions":473,"keywords":474,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":480,"leadSponsor":482,"locationsCount":159},"100544844","phase-1-a-phase-1-study-to-evaluate-tgi-6-in-subjects-with-locally-advancedmetastatic-solid-tumors-100544844","NCT06374173","A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced\u002FMetastatic Solid Tumors","A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics\u002F Pharmacodynamics, and Antitumor Activity of TGI-6 as Monotherapy in Subjects With Locally Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Male or female subjects age ≥18 years at the time of informed consent.\n2. Phase 1a: Subjects with histologically or cytologically diagnosed unresectable locally advanced\u002Fmetastatic CRC. Or subjects with confirmed B7-H6-positive unresectable locally advanced\u002Fmetastatic solid tumors, mainly but not limited to TNBC, HCC, HNSCC, SCLC, OC, GC, pancreatic cancer, and melanoma.\n\n   Phase 1b Cohort 1: Subjects must have pathologically documented, definitively diagnosed unresectable locally advanced and\u002For metastatic CRC.\n\n   Phase 1b Cohort 2: Subjects must have pathologically documented, definitively diagnosed unresectable locally advanced and\u002For metastatic solid tumors with B7-H6-positive, mainly but not limited to TNBC, HCC, HNSCC, SCLC, OC, GC, pancreatic cancer, and melanoma.\n3. Phase 1a or Phase1b Cohort 2: Subjects should have progressed despite all standard therapy or be intolerant of all standard therapy, or for whom no standard therapy exists. (Standard therapies are defined as treatments recommended by local guidelines, including, but not limited to, chemotherapy, radiation, target therapies based on mutation status, immunotherapy, and surgery in general).\n4. All subjects except subjects with CRC must agree to the collection of tumor samples for confirmation of B7-H6 expression status in a central lab.\n5. Subjects in Phase 1a must have at least one evaluable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Subjects in Phase 1b must have least one measurable lesion as defined per RECIST v1.1 which has not received radiotherapy (or progressive disease after radiotherapy).\n6. ECOG PS (Appendix 5) of 0\\~2.\n7. Life expectancy ≥3 months.\n8. Subjects have sufficient baseline organ function and laboratory data .\n9. Woman of childbearing potential must have a negative serum pregnancy test within 7 days prior to treatment.\n10. Female subjects of childbearing potential or male subjects with a partner of childbearing potential must agree to use effective contraception at the time of informed consent and continuing through the study until 6 months after the last dose of TGI-6.\n\nExclusion Criteria:\n\n1. Subject with known active central nervous system (CNS) primary tumor or metastases.\n2. History of intercurrent severe chronic or active infections.\n3. Has a history of active autoimmune diseases .\n4. Has a history of symptomatic interstitial lung disease.\n5. Toxicities of prior therapies have not been resolved to Grade ≤1 or baseline as per NCI-CTCAE v5.0, except for alopecia, skin hyperpigmentation, Grade 2 neuropathy and Grade 2 endocrinopathy that is well controlled by replacement therapy.\n6. Subjects with severe or uncontrolled cardiovascular disorder requiring treatment.\n7. Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation.\n8. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years .\n9. Evidence of clinically significant immunosuppression .\n10. Presence of uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures .\n11. Previously treated with the following anti-tumor therapy (prior to the first dose of TGI-6):\n\n1\\) Previous treated with any B7-H6-targeting therapy. 2) Chemotherapy, target therapy, immunotherapy, or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment, except:\n\n1. Washout period for nitrosoureas or mitomycin is ≤6 weeks.\n2. ≤5 half-lives or 2 weeks (whichever is longer) for fluoropyrimidines or small-molecule targeted agents.\n3. Washout period for herbal therapy with anticancer indications is ≤2 weeks. 3) Prior radiotherapy ≤4 weeks prior to the first dose of study treatment, with the exception of a single fraction of radiotherapy for the purposes of palliation, which is permitted.\n\n   4\\) Subject participated in any other clinical study and has received an investigational product within 28 days prior to the first dose of TGI-6.\n\n   12\\. Has received systematic immunomodulatory drugs within 14 days before the first dose of study drug, such as thymosin, IL-2, and interferon (IFN).\n\n   13\\. Has received a live vaccine within 4 weeks prior to the first dose of study drug.\n\n   14\\. Has a recent major surgery within 4 weeks prior to the first dose of study drug or is expected to undergo major surgery during the study.\n\n   15\\. Subject requiring anticoagulant treatment which cannot be safely interrupted, if medically needed for a study procedure (e.g., biopsy) based on the opinion of the Investigator.\n\n   16\\. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.\n\n   17\\. Pregnancy or lactation. 18. Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product.\n\n   19\\. Pre-existing other serious medical conditions, familial or endemic disease that, in the opinion of the investigator, will interfere with planned staging, treatment, and follow-up, subject compliance, or will place the subject at high risk for treatment-related complications.\n\n   20\\. Subjects who are unwilling or unable to comply with study procedures and study restrictions, or in the judgment of the investigator, would make the subject inappropriate for entry into this study.",{"count":470,"type":20},123,[23],"A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced\u002FMetastatic Solid Tumors",[32],[475,182,40],"TGI6","2024-04-16",{"date":478,"type":51},"2024-04-18",{"date":298,"type":51},{"date":481,"type":20},"2027-12",{"name":483,"class":461},"Hefei TG ImmunoPharma Co., Ltd.",{"id":485,"slug":486,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":21,"phases":492,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":431,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":130},"100489418","phase-1-study-of-mhb088c-in-participants-with-advanced-or-metastatic-solid-tumors-100489418","NCT05652855","Study of MHB088C in Participants With Advanced or Metastatic Solid Tumors","Phase 1\u002F2, Two-Part, Multi-center, Open-label, Dose Escalation and Dose Expansion First-In-Human Study to Evaluate the Safety\u002FTolerability, Pharmacokinetics and Efficacy of MHB088C in Participants With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n\\-\n\nParticipants enrolled must meet all of the following criteria:\n\nGeneral conditions\n\n1. Participants voluntarily agree to participate in the study and sign the Informed Consent Form.\n2. Aged ≥18years, without gender limitation.\n3. Has an Eastern Cooperative Oncology Group Performance score (ECOG) 0 \\~ 1.\n4. Has a life expectancy of ≥ 3 months.\n5. Eligible participants of childbearing potential (males and females) must agree to take highly reliable contraceptive measures (hormone or barrier method, or absolute abstinence, etc.) with their partners during the study and within at least 90 days after the last dose and agree not to retrieve, freeze or donate sperm or ova from screening to at least 3 months after the last dose of investigational drug; female participants of childbearing potential must have a negative results of blood pregnancy test within 7 days before the first dose of investigational drug, and must be non-lactating.\n6. Understand study requirements, willing and able to comply with study and follow-up procedures.\n\n   Neoplasm-related criteria\n7. Part one: Histologically or cytologically confirmed unresectable advanced or metastatic malignant solid tumors, that is progressed or intolerant with standard of care (SOC), or for which no SOC regimens are available;\n8. Part two: Histologically or cytologically confirmed unresectable advanced or metastatic malignant solid tumors, that is relapsed or progressed following systemic treatment or no standard of care is available, including but not limited to the following types: non-small cell lung cancer (NSCLC); small cell lung cancer (SCLC); esophageal squamous cell carcinoma (ESCC); castration-resistant prostate cancer (CRPC); melanoma (MEL); colorectal cancer (CRC); pancreatic ductal adenocarcinoma (PDAC); head and neck squamous cell carcinoma (HNSCC); hepatocellular carcinoma (HCC); ovarian cancer (OC); endometrial cancer (EC); thyroid cancer (TC); and sarcoma (SARC).\n\n   1. Additional inclusion criteria for participants with NSCLC:\n\n      Histologically or cytologically documented unresectable advanced or metastatic NSCLC and previous progressed during or after systematic treatment with platinum-contained doublet regimens chemotherapy and immune-checkpoint inhibitors (ICIs); refractory, intolerant or not suitable to the target therapy as per investigator discretion for participants with driver gene mutation.\n   2. Additional inclusion criteria for participants with SCLC:\n\n      Histologically or cytologically documented unresectable advanced or metastatic SCLC and previous progressed during or after ≥1 lines of systematic treatment with platinum-based, doublet regimens chemotherapy and ICIs.\n   3. Additional inclusion criteria for participants with ESCC:\n\n      Histologically or cytologically documented unresectable advanced or metastatic ESCC previous progressed during or after≥1 line platinum-based of systemic treatment.\n   4. Additional inclusion criteria for participants with CRPC:\n\n      Histologically or cytologically documented CRPC without neuroendocrine differentiation or small cell elements; Underwent surgical or medical castration, with testosterone levels below 50 ng\u002FdL; Objective progression as determined by radiographic after androgen deprivation therapy; Relapsed or progressed during or after at least one of the following medicines: abiraterone, enzalutamide, apalutamide, or darolutamide; Relapsed or progressed during or after≥ 1 line of docetaxel\u002Fmitoxantrone-based cytotoxic chemotherapy regimens for metastatic CRPC; With at least 1 documented lesion confirmed by either a bone scan or a CT\u002FMRI scan.\n   5. Additional inclusion criteria for participants with MEL:\n\n      Histologically or cytologically documented unresectable advanced or metastatic MEL and previous progressed during or after ≥1 line of systemic therapy including ICIs\n   6. Additional inclusion criteria for participants with CRC:\n\n      Histologically or cytologically documented unresectable advanced or metastatic CRC and previous progressed during or after systematic chemotherapy containing oxaliplatin, irinotecan, fluorouracil and immunotherapy (for participants with MSI-H\u002FdMMR).\n   7. Additional inclusion criteria for participants with PDAC:\n\n      Histologically or cytologically documented unresectable advanced or metastatic PDAC and previous progressed during or after ≥ 1 line of systemic therapy in neoadjuvant, adjuvant, locally advanced or metastatic setting.\n   8. Additional inclusion criteria for participants with HNSCC:\n\n      Histologically or cytologically documented unresectable advanced or metastatic HNSCC and previous progressed during or after ≥ 1 line of systemic therapy, including platinum-based chemotherapy and ICIs (combined or sequential therapy).\n   9. Additional inclusion criteria for participants with HCC:\n\n      Histologically or cytologically documented unresectable advanced or metastatic HCC and previously progressed during or after ≥ 1 line of systemic therapy, including anti-vascular therapy and\u002For ICI therapy.\n   10. Additional inclusion criteria for participants with OC:\n\n       Histologically or cytologically documented unresectable advanced or metastatic OC including less-common histology per National Comprehensive Cancer Network (NCCN) of epithelial ovarian cancer as well as fallopian tube cancer and primary peritoneal cancer and have relapsed or progressed during or after ≥ 1 line of platinum-based systemic chemotherapy treatment.\n   11. Additional inclusion criteria for participants with EC:\n\n       Histologically or cytologically documented unresectable advanced or metastatic EC and recurrence after radical therapy, and previously treated and progressed during or after ≥ 1 line of standard systemic therapy.\n   12. Additional inclusion criteria for participants with TC:\n\n       Histologically or cytologically documented unresectable advanced or metastatic TC and previous progressed during or after ≥ 1 line of systemic therapy including platinum-based chemotherapy or targeted therapy.\n   13. Additional inclusion criteria for participants with SARC:\n\n   Histologically or cytologically documented unresectable advanced or metastatic SARC and previous progressed during or after ≥ 1 prior line of systemic therapy including doxorubicin-based chemotherapy.\n9. Agree to provide the pre-existing diagnostic tumor samples for retrospective testing of target expression and other biomarkers (participants who agree but are unable to provide pre-existing tumor sample may also be enrolled). There is no minimum target expression level required for inclusion.\n10. Has at least one measurable tumor lesion as per RECIST v1.1(generally, previously irradiated areas or locoregionally treated sites will not be considered as measurable lesions, unless these lesions have clearly progressed or still exist three months after radiotherapy); for participants with CRPC, evaluable lesions as defined by PCWG3 criteria or at least one measurable soft tissue tumor lesion as per RECIST v1.1 are required.\n\n    Adequate bone marrow reserve and organ functions:\n11. Adequate bone marrow reserve (without transfusion or colony-stimulating factor or equivalent within7 days before the screening period testing); Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; Platelet count ≥ 100 × 10\\^9\u002FL; Hemoglobin ≥ 9.0 g\u002FdL.\n12. Adequate hepatic function (with reference to normal values specified by the clinical study site):\n\n    Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); TBIL ≤ 2 × ULN if Gilbert's syndrome is present; TBIL ≤ 3.0 × ULN is permitted if direct bilirubin (DBIL) suggests extrahepatic obstruction.\n\n    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) shall be ≤ 3 × ULN with non-hepatic tumors and without hepatic metastasis; AST and ALT shall be ≤ 5.0 × ULN with hepatic tumors or hepatic metastasis;\n13. Adequate renal function (with reference to normal values specified by the clinical study site):\n\n    Creatinine (Cr) ≤ 1.5 × ULN; when Cr \\> 1.5 × ULN, only participants with creatinine clearance (Ccr) ≥ 50 mL\u002Fmin can be enrolled (using Cockcroft-Gault formula);\n14. Adequate coagulation function:\n\n    Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, and international normalized ratio (INR) ≤ 1.5 × ULN.\n15. Adequate cardiac function:\n\nLeft ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram within 28 days before enrollment; New York Heart Association (NYHA) Class \\\u003C grade 3.\n\nExclusion Criteria:\n\n\\-\n\nParticipants will be not enrolled if they meet any of the following exclusion criteria:\n\nNeoplasm-related criteria:\n\n1. Has more than 2 primary malignancies (except curatively treated non-melanoma skin cancer, in situ disease, and other curatively malignancies have considered cured) within 5 years before signing of Informed Consent Form.\n2. Has received chemotherapy within 3 weeks, or have received anti-tumor treatment including radiation therapy, biologic therapy, endocrine therapy, immunotherapy, etc. within 4 weeks before the first dose of investigational product; or participants with the following conditions:\n\n   Medication of nitrosourea or mitomycin C within 6 weeks before the first dose of investigational drug; Medication of oral fluoropyrimidines and small molecule targeted agents within 5 half-lives before the first dose of investigational drug; Medication of traditional Chinese medicine with anti-tumor indication within 2 weeks before the first dose of investigational drug.\n3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug.\n4. Presence of brain metastases and\u002For leptomeningeal carcinomatosis. Participants previously treated for brain metastases may be considered to be enrolled in this study, provided they have been in stable condition for at least 1 month, have no progression confirmed by radiographic examination within 4 weeks before the first dose of study treatment, all neurological symptoms have stabled, there is no evidence of new or enlarging brain metastases, and radiation or surgical therapy is discontinued for at least 28 days before the first dose of study treatment and steroid therapy at the dose of ≤10 mg\u002Fday or similar drugs at equivalent dose within 14 days before the first dose and during the study. This exception does not include carcinomatous meningitis, which should be excluded regardless of clinical stability.\n5. Has previously received same target therapy.\n6. Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1 (except for toxicities without safety risks as determined by the investigator, such as alopecia, hypothyroidism stably managed by hormone replacement therapy, etc.).\n\n   General conditions:\n7. Has underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose of investigational drug or requiring elective surgery during the study.\n8. Has vaccinated with attenuated live vaccines (except for SARS-CoV-2 vaccination) within 4 weeks before the first dose of investigational drug.\n9. Has mucosal or internal bleeding for non-traumatic reason within 4 weeks before the first dose of investigational drug.\n10. Has received treatment with systemic corticosteroids (prednisone at \\>10 mg\u002Fday, or similar drugs at equivalent dose) or other immunosuppressive agents within 14 days before the first dose of investigational drug, with the following exceptions:\n\n    Treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; Short-term use of glucocorticoids for prophylaxis (e.g., prevention of contrast media allergy).\n11. Has pulmonary disease that severely impact pulmonary function, including, but not limited to, potential pulmonary disease, any autoimmune diseases, connective tissue diseases, or inflammatory diseases involving the pulmonary, or pneumonectomy.\n12. Has history of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, or current ILD\u002Fpneumonia, or suspected ILD\u002Fpneumonia that cannot be excluded by imaging examination at screening.\n13. Has active pulmonary tuberculosis.\n14. Has active infection requiring systemic therapy.\n15. Has positive results in virus serology tests (participants receiving antiviral prophylaxis other than interferon are allowed to be enrolled):\n\n    Positive result of HIV antibody; Or, positive for both HBsAg and HBV-DNA (i.e., HBV DNA ≥LLOD); Or, positive for HCV Ab (except HCV-RNA \\\u003C LLOD).\n16. Has positive result for covid-19 nucleic acid test.\n17. Medical history of serious cardiovascular and cerebrovascular diseases, including but not limited to:\n\n    Severe arrhythmia or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, or atrioventricular block Ⅱ\\~Ⅲ degree; Fridericia-corrected QT interval (QTcF) prolongation to \\>450 milisecond (ms) for males and \\> 470 ms for females; Acute coronary syndrome, aortic dissection, stroke or transient ischemic attack (TIA) within 6 months before the first dose; New myocardial infarction or unstable angina within 6 months before the first dost; Clinically uncontrolled hypertension;\n18. Has clinically uncontrolled effusion in third spacing, deemed as inappropriate for enrollment by the investigator.\n19. Hypersensitivity or delayed hypersensitivity to certain components or analogues of the investigational drug.\n20. Has drug abuse or any other medical conditions, such as clinically significant psychological conditions that may interfere with study participation or the results of the clinical study as per investigator discretion.\n21. Has alcohol or drug dependence.\n22. Females who are pregnant or breastfeeding, or males\u002Ffemales who plan to father a child\u002Fget pregnant.\n23. Poor compliance as per investigator discretion, has history of other serious systemic diseases, or unsuitable to participate this clinical study for some reasons.",{"count":421,"type":20},[23,71],"This study will evaluate the safety\u002Ftolerability, pharmacokinetics and efficacy of MHB088C in participants with advanced or metastatic solid tumors.",[32],"2023-01-05",{"date":497,"type":51},"2023-01-09",{"date":499,"type":20},"2023-01-23",{"date":501,"type":20},"2026-07-31",{"name":503,"class":58},"Minghui Pharmaceutical Pty Ltd"]