[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rcc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rcc":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,51,77,99,120,173,197,225],{"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":35,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100616025","phase-1-open-label-phase-12-study-of-neo-811-in-subjects-with-locally-advanced-or-metastatic-non-resectable-clear-cell-renal-cell-carcinoma-100616025",false,"NCT07300241","Open-Label Phase 1\u002F2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma","An Open-Label, First-in-Human, Phase 1\u002F2 Dose Escalation and Expansion Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n* Subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC).\n* Subjects must have progressed on or refused standard therapies.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.\n* Estimated life expectancy, in the judgment of the Investigator, of at least 12 weeks.\n* Formalin-fixed paraffin-embedded (FFPE) tumor tissue, newly obtained or archival, is mandatory for enrollment to the study.\n* Measurable disease as defined by RECIST v1.1.\n* Adequate hematologic, hepatic, and renal function defined as:\n\n  * Hemoglobin ≥10 g\u002FdL,\n  * Absolute neutrophil count ≥1000 cells\u002FµL,\n  * Platelet count ≥100,000\u002FµL,\n  * AST and ALT ≤2.5 × ULN, or AST and ALT ≤5 × ULN for subjects with liver metastases,\n  * Total bilirubin ≤1.5 × ULN,\n  * Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin.\n* Subject can swallow oral medications and does not have a condition that could impair the oral bioavailability of the study drug.\n* Other inclusion criteria per protocol.\n\nExclusion Criteria:\n\n* Non-clear cell predominant RCC histologic subtypes.\n* Leptomeningeal disease or symptomatic active CNS metastases with exceptions for asymptomatic treated CNS metastases per protocol.\n* Prior or concurrent malignancies with exceptions per protocol.\n* History of hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV infection.\n* Other exclusion criteria per protocol.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The NEO-811-101 study is an open-label, first-in-human, Phase 1\u002F2 dose escalation and expansion study testing NEO-811, an ARNT molecular glue degrader, in subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma. The study will test NEO-811 initially as a monotherapy.",[26,27,28,29,30,31,32,33,34],"Clear Cell Renal Cell Carcinoma","Renal Cell Carcinoma","RCC","Clear Cell Renal Cell Carcinoma Metastatic","ccRCC","VHL-Associated Clear Cell Renal Cell Carcinoma","VHL-Associated Renal Cell Carcinoma","Kidney Cancer Metastatic","Kidney Cancers",[30,27,26,36,37],"VHL","Kidney Cancer","RECRUITING","2026-05-29",{"date":41,"type":42},"2026-06-02","ACTUAL",{"date":44,"type":42},"2025-12-19",{"date":46,"type":20},"2027-09",{"name":48,"class":49},"Neomorph, Inc","INDUSTRY",10,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100617919","a-multicenter-real-world-study-on-tki-therapy-after-progression-on-first-line-tkiio-therapy-or-tkiio-therapy-after-progression-on-first-line-tki-in-chinese-patients-with-metastatic-renal-cell-carcinoma-mrcc-100617919","NCT07324876","A Multicenter Real-World Study on TKI Therapy After Progression on First-Line TKI\u002FIO Therapy or TKI\u002FIO Therapy After Progression on First-Line TKI in Chinese Patients With Metastatic Renal Cell Carcinoma (mRCC)","Inclusion Criteria:\n\n1. Subjects with histologically confirmed unresectable metastatic renal cell carcinoma (mRCC) will be included in the study. Previous nephrectomy or metastasectomy is allowed, but no prior systemic anticancer therapy targeting RCC is permitted.\n2. Classified as low- or intermediate-risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria.\n3. Male or female subjects aged 18 years or older at the time of signing the informed consent form.\n4. Defined as Chinese ethnicity, with both biological parents and all four biological grandparents being of Chinese descent.\n5. Patients who progressed or were intolerant to first-line TKI therapy (including sunitinib, pazopanib, cabozantinib, sorafenib, axitinib, lenvatinib, etc.) and subsequently received TKI\u002FIO therapy (including axitinib\u002F lenvatinib\u002F cabozantinib combined with toripalimab\u002F tislelizumab\u002F pembrolizumab\u002F sintilimab\u002F nivolumab, etc.).\n6. Patients who progressed or were intolerant to first-line TKI\u002FIO therapy (including axitinib\u002F lenvatinib\u002F cabozantinib combined with toripalimab\u002F tislelizumab\u002F pembrolizumab\u002F sintilimab\u002F nivolumab, etc.) and subsequently received TKI therapy (including sunitinib, pazopanib, cabozantinib, sorafenib, axitinib, lenvatinib, etc.).\n7. Karnofsky Performance Status (KPS) ≥ 70% within 10 days prior to the first dose of treatment.\n8. Adequate organ function as evidenced by laboratory values: ANC ≥ 1500\u002FμL; platelets ≥ 100,000\u002FμL; hemoglobin ≥ 10.0 g\u002FdL or ≥ 6.2 mmol\u002FL; CrCl ≥ 30 mL\u002Fmin; AST and ALT ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN; and INR or PT ≤ 1.5 × ULN.\n\nExclusion Criteria:\n\n1. Requiring intermittent oxygen supplementation at rest, or long-term oxygen therapy.\n2. Clinically significant cardiovascular disease within 6 months prior to the first dose of study intervention.\n3. Severe active, non-healing wound, ulcer, or fracture.\n4. Use of colony-stimulating factors (e.g., G-CSF, GM-CSF), recombinant erythropoietin (EPO), or blood transfusion within 28 days prior to the first dose of study intervention.\n5. Inability to swallow oral medications or a history of, or current evidence of, gastrointestinal diseases (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis) or impaired liver function, or other conditions that, in the investigator's opinion, may significantly alter the absorption or metabolism of oral study interventions.\n6. Severe hypersensitivity reactions to TKI drugs, IO drugs, and\u002For any excipients.\n7. Diagnosis of immunodeficiency or use of long-term systemic corticosteroids (daily dose exceeding 10 mg prednisone or equivalent) or any form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n8. Diagnosis of another malignancy (excluding RCC treated by nephrectomy and\u002For metastasectomy) that is currently progressing or required active treatment in the past 3 years. Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding bladder carcinoma in situ) who have undergone potentially curative treatment are eligible.\n9. Active autoimmune disease requiring systemic treatment (i.e., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment and is allowed.\n10. History of or current (non-infectious) pneumonitis\u002Finterstitial lung disease requiring steroid treatment, or current pneumonitis\u002Finterstitial lung disease.\n11. Active infection requiring systemic treatment.\n12. Known history of HIV infection, hepatitis B (defined as HBsAg reactive), or active hepatitis C virus (defined as detectable HCV RNA \\[qualitative\\]). Note: Testing for HIV, HBV, or HCV is not required unless mandated by local health regulations.\n13. Any prior or current condition, treatment, laboratory abnormality, or other circumstance that may interfere with the study results, affect the subject's ability to complete the study, or, in the investigator's opinion, make the subject unsuitable for participation or unlikely to benefit from the study.\n14. Known psychiatric or substance abuse disorders that would interfere with the subject's ability to comply with study requirements\n15. History of prior allogeneic tissue\u002Fsolid organ transplantation.\n16. If the subject is a non-pregnant and non-lactating female, the subject must agree to use highly effective (failure rate \\\u003C1% per year) and low-dependency contraceptive methods during treatment.","90 Years",{"count":59,"type":20},860,"OBSERVATIONAL","TKI monotherapy or TKI\u002FIO combination therapy is the standard first-line treatment for low- and intermediate-risk advanced renal cell carcinoma (RCC). In clinical practice, after the failure of first-line therapy, sequential treatment is often selected based on the initial regimen, with options including TKI\u002FIO therapy or TKI therapy. In the real-world setting of low- and intermediate-risk advanced RCC in China, which sequential treatment strategy-TKI\u002FIO-TKI or TKI-TKI\u002FIO-provides greater survival benefits for patients? This study aims to compare the efficacy, safety, and cost-effectiveness of TKI\u002FIO-TKI sequential therapy versus TKI-TKI\u002FIO sequential therapy in real-world low- and intermediate-risk mRCC patients. The objective is to accurately identify the optimal patient subgroups for each treatment strategy, optimize treatment plans, improve patient quality of life, reduce healthcare costs, provide guidance and reference for the clinical management of low- and intermediate-risk mRCC patients, and contribute to the refinement and updating of related Chinese treatment guidelines.",[28],[64],"tyrosine kinase inhibitors","NOT_YET_RECRUITING","2025-12-23",{"date":68,"type":42},"2026-01-08",{"date":70,"type":20},"2025-12-31",{"date":72,"type":20},"2028-12-31",{"name":74,"class":75},"Tianjin Medical University Cancer Institute and Hospital","OTHER",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":83,"targetDuration":85,"studyType":60,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":76},"100509720","renal-cancer-monitoring-based-on-ctdna-methylomics-a-prospective-cohort-study-memory-study-100509720","NCT05917106","Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study)","Inclusion Criteria:\n\n* Newly diagnosed renal cell carcinoma\n* Without any treatment\n* Agree and accept radical surgical treatment\n* Signed written informed consent\n* ECOG(Eastern Cooperative Oncology Group) performance is 0 or 1\n* Follow up protocol and related procedures\n\nExclusion Criteria:\n\n* Had other cancers\n* Had received any antitumor therapy before\n* Known or suspected active autoimmune disease\n* Informed consent is not possible due to medical or psychiatric problems\n* Have clinical symptoms or diseases of the heart that are not well controlled\n* Patients judged by the investigators to be unsuitable for inclusion in this study",{"count":84,"type":20},450,"5 Years","To conduct prospective studies to confirm the value of circulating tumor DNA and its abnormal methylation in longitudinal monitoring of patients undergoing kidney cancer surgery.",[88,27,28,89,37],"Carcinoma","Kidney Neoplasms","2025-12-04",{"date":92,"type":42},"2025-12-11",{"date":94,"type":42},"2022-12-26",{"date":96,"type":20},"2030-06",{"name":98,"class":75},"Jinling Hospital, China",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":118,"locationsCount":76},"100510819","phase-2-sequential-treatment-of-cabozantinib-for-advanced-renal-cell-carcinoma-rcc-100510819","NCT05931393","Sequential Treatment of Cabozantinib for Advanced Renal Cell Carcinoma (RCC)","Phase 2, Open-label, Single Cohort, Multicenter Trial for Sequential Treatment of High Dose Cabozantinib on\u002FAfter Progression on Cabozantinib Monotherapy in Advanced Renal Cell Carcinoma (Seq-Cabo)","Inclusion Criteria:\n\n1. Patients with advanced RCC (defined as locally advanced unresectable or metastatic) of any histology who progressed on\u002Fafter cabozantinib monotherapy in any line of treatment. Patient must have cabozantinib sensitive disease (prior treatment with cabozantinib ≥ 6 months)\n2. Ability to tolerate prior cabozantinib at 60mg PO daily with manageable toxicity profile at the respective doses, at investigator discretion\n3. Prior PD-1 inhibitor\u002FPD-L1 inhibitor allowed\n4. Evidence of measurable disease per RECIST 1.1\n5. For up to 5 patients opting into on-treatment biopsy, one of the following must be met:\n\n   1. Archival tissue confirmed to be available and obtained within 30 days of informed consent as well as willingness to undergo an on-treatment biopsy at 12 weeks (+\u002F- 7 days).\n\n      OR\n   2. Willingness to undergo a baseline biopsy prior to Cycle 1 Day1, as well as an on-treatment biopsy at 12 weeks (+\u002F- 7 days).\n6. Age ≥ 18 at time of consent\n7. ECOG performance status ≤ 2\n8. Capable of understanding and complying with the protocol requirements and must have signed the informed consent document\n9. No washout period is needed for cabozantinib, minimum of 4 weeks or 4 half-lives washout, whichever is shorter, for other standard or experimental anti-cancer therapies.\n10. Recovery to baseline or ≤ Grade 1 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy\n11. Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment:\n\n    1. Absolute neutrophil count (ANC) ≥ 1500\u002FµL without granulocyte colony-stimulating factor (G-CSF) support\n    2. White blood cell (WBC) count ≥ 2500\u002FµL\n    3. Platelets ≥ 100,000\u002FµL without transfusion\n    4. Hemoglobin ≥ 9 g\u002FdL (≥ 90 g\u002FL) (transfusion acceptable per investigator discretion)\n    5. Alanine transaminase (ALT), AST and alkaline phosphatase (ALP) ≤ 3 x ULN. ALP ≤ 5x ULN with documented bone metastases\n    6. Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3x ULN)\n    7. Serum albumin ≥ 2.8 g\u002Fdl\n    8. Prothrombin (PT)\u002Finternational normalized ratio (INR) or partial thromboplastin time (PTT) test \\\u003C 1.3x the laboratory ULN\n    9. Serum creatinine ≤ 1.5x ULN or calculated creatinine clearance ≥ 40mL\u002Fmin (≥ 0.675mL\u002Fsec) using the Cockcroft-Gault equation:\n\n       * Males: (140 - age) x weight (kg)\u002F(serum creatinine \\[mg\u002FdL\\] × 72)\n       * Females: \\[(140 - age) x weight (kg)\u002F(serum creatinine \\[mg\u002FdL\\] × 72)\\] × 0.85\n    10. Urine protein\u002Fcreatinine ratio (UPCR) ≤1 mg\u002Fmg (≤113.2 mg\u002Fmmol), or 24h urine protein ≤1 g\n12. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of cabozantinib\n\nShould a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\n1. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:\n\n   * documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or\n   * documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes.\n2. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating hormone (FSH) level \\> 40 mIU\u002FmL to confirm menopause.\n\nExclusion Criteria:\n\n1. Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible\n2. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for 1) at least 2 weeks after radiotherapy or 2) at least 4 weeks after major surgery (e.g., removal or biopsy of brain metastasis) prior to first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment for the brain metastasis at the time of first dose of study treatment\n3. Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following: 1) prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH). 2) Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor\n4. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n   1. Cardiovascular disorders: 1) congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias; 2) uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment within 1 week of treatment; 3) stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis \\[DVT\\], pulmonary embolism \\[PE\\]) within 6 months before first dose of study treatment. Note: subjects with a diagnosis of incidental, subsegmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation (see exclusion criterion #3.2.4) for at least 1 week before first dose of study treatment\n   2. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation, including 1) the subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction; 2) abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment\n5. Clinically significant hematuria, hematemesis, hemoptysis, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 6 weeks before first dose of study treatment. (Clinically significant hematuria defined by needing transfusion; clinically significant hematemesis or hemoptysis defined by needing hospital admission)\n6. Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation. Cavitary pulmonary lesions are allowed if not symptomatic.\n7. Lesions invading or encasing any major blood vessels\n8. Other clinically significant disorders that would preclude safe study participation\n\n   1. Serious non-healing wound\u002Fulcer\u002Fbone fracture\n   2. Moderate to severe hepatic impairment (Child-Pugh B or C).\n   3. Acute COVID-19 infection - clinical recovery from COVID-19 infection at least 14 days prior to enrollment allowed.\n9. Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment. Minor surgeries within 10 days before first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible\n10. Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms per electrocardiogram (ECG) within 14 days before first dose of study treatment. Furthermore, subjects with a history of additional risk factors for torsades de pointes (e.g., long QT syndrome) are also excluded. Note: If a single ECG shows a QTcF with an absolute value \\> 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility.\n11. Pregnant or lactating females\n12. Inability to swallow tablets\n13. Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies. Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption are also excluded\n14. Another malignancy within 2 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, Gleason 6 prostate cancer, or carcinoma in situ of cervix or breast",{"count":107,"type":20},18,[109],"PHASE2","The goal of this clinical trial is to learn about the effects of a higher dose of ncabozantinib in patients with advanced renal cell carcinoma who have progressed on or after receiving cabozantinib treatment.",[28,27],"2025-10-08",{"date":114,"type":42},"2025-10-10",{"date":116,"type":42},"2023-12-20",{"date":72,"type":20},{"name":119,"class":75},"University of Texas Southwestern Medical Center",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":130,"briefSummary":131,"conditions":132,"keywords":147,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":50},"100568558","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-a2b395-an-allogeneic-logic-gated-car-t-in-participants-with-solid-tumors-that-express-egfr-and-have-lost-hla-a02-expression-100568558","NCT06682793","A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression","A Seamless Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression","DENALI-1","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\\*02 by NGS (whenever possible from the primary site).\n2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, HNSCC, TNBC, RCC, or other solid tumors with EGFR expression. Measurable disease is required with lesions of ≥1.0 cm by CT.\n3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol\n4. Has adequate organ function as described in the protocol\n5. ECOG performance status of 0 to 1\n6. Life expectancy of ≥3 months\n7. Willing to comply with study schedule of assessments including long-term safety follow-up\n\nKey Exclusion Criteria:\n\n1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative\n2. Prior allogeneic stem cell transplant\n3. Prior solid organ transplant\n4. Cancer therapy within 3 weeks or 3 half lives of A2B395 infusion\n5. Radiotherapy within 28 days of A2B395 infusion\n6. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months\n7. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated\n8. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year\n9. Requires supplemental home oxygen\n10. Females of childbearing potential who are pregnant or breastfeeding\n11. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion of A2B395",{"count":129,"type":20},240,[23,109],"The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\\*02 expression.\n\nThe main questions this study aims to answer are:\n\n* Phase 1: What is the recommended dose of A2B395 that is safe for patients\n* Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells\n\nParticipants will be required to perform study procedures and assessments, and will also receive the following study treatments:\n\n* Enrollment in BASECAMP-1 (NCT04981119)\n* Preconditioning lymphodepletion (PCLD) regimen\n* A2B395 Tmod CAR T cells at the assigned dose",[133,134,135,136,137,138,139,140,141,142,143,27,28,37,144,145,146],"Solid Tumor, Adult","Colorectal Cancer","Non-Small Cell Lung","NSCLC (Non-small Cell Lung Cancer)","Cancer","Colon Cancer","Rectal Cancer","Lung Cancer","CRC","Head and Neck Squamous Cell Cancer","HNSCC","Triple Negative Breast Cancer","TNBC","Colorectal Adenocarcinoma",[148,149,150,151,152,153,154,141,155,156,157,158,137,159,160,140,161,28,37,162,163,145],"CAR T Cell","Solid Tumors","Allogeneic","T Cell","EGFR","HLA-A2","Solid tumors expressing EGFR","Colorectal","Cell Therapy","Gene Therapy","Blocker","NSCLC","Non small Cell Lung Cancer","renal cell carcinoma","Renal cell cancer","Triple negative breast cancer","2025-09-03",{"date":166,"type":42},"2025-09-09",{"date":168,"type":42},"2025-05-22",{"date":170,"type":20},"2030-03-31",{"name":172,"class":49},"A2 Biotherapeutics Inc.",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":21,"phases":183,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":194,"locationsCount":196},"100536032","phase-1-a-study-of-spx-303-a-bispecific-antibody-targeting-lilrb2-and-pd-l1-in-patients-with-solid-tumors-100536032","NCT06259552","A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors","A Phase 1, Open-label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of an Anti-LILRB2 \u002F PD-L1 Bispecific Antibody SPX- 303 in Patients With Solid Tumors","SPX-303","Inclusion Criteria:\n\n1. Males and females ≥18 years of age who comprehend, are not incarcerated, are willing and able to provide consent by signing an ICF, and able to comply with scheduled visits, treatment schedule, and laboratory tests, including other requirements for the study\n2. Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy\n3. Patients who have progressed on or after prior therapy and who are not eligible for available treatment options\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. Has at least 1 measurable lesion per RECIST 1.1 criteria\n6. Recovery from previous treatment related adverse events (TRAEs) to allow safety evaluations of SPX-303. Previous TRAEs include adverse drug reactions, and consequences of radiation, surgery, and other therapeutic modalities\n7. Adequate hepatic function; bilirubin ≤1.5x upper limit of normal (ULN) (except for patients with Gilbert syndrome: ≤ 3xULN), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤2.5 x ULN (≤5 x ULN if liver metastases present).\n8. Adequate renal function as calculated (e.g. Cockroft Gault) creatine clearance (CrCl) ≥ 30 mL\u002Fmin or 24-hour urine CrCl ≥ 30 mL\u002Fmin.\n9. Adequate hematological function: absolute neutrophil count (ANC) ≥1 x 10\\^9\u002FL; platelets ≥75 x 10\\^9\u002FL, hemoglobin ≥9 g\u002FdL.\n10. Patients with well controlled HIV infection (ie CD4+ count \\>350 cells\u002FuL and viral copies less than 400\u002FmL after at least 4 weeks of ART) are eligible for the trial.\n11. Adequate coagulation function: INR, PT and aPPT ≤ 1.5x ULN except for patients on anti-coagulation as long as PT, aPPT, or INR are within intended range.\n12. Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 45% by multi-gated acquisition (MUGA) or echocardiography (ECHO) scan.\n13. Fridericia-corrected QT interval (QTcF) ≤480 msec.\n14. Women of childbearing potential must have a negative pregnancy test and must agree to use of 2 different methods of acceptable contraception from screening until 4 months after the last dose of study drug. Acceptable methods of contraception are defined as those that result, alone or in combination, in a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as surgical sterilization, an intrauterine device, hormonal contraception in combination with a barrier method or abstinence).\n15. Males who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception (eg, condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) from screening until 4 months following the last dose of study drug, in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until 4 months following the last dose of study drug. This criterion may be waived for male patients who have had a vasectomy \\>6 months before signing the ICF.\n\nExclusion Criteria:\n\n1. History of prior malignancy, except for adequately treated in situ cancer, basal cell, or squamous cell skin cancer, or other cancers (eg, breast, prostate) for which the patient has been disease free for at least 3 years. Prostate cancer patients on active surveillance are eligible.\n2. Active brain or leptomeningeal metastasis. Except patients with known brain metastases if they have been treated and MRI shows no evidence of progression for at least 8 weeks and require less than 10 mg\u002Fday prednisone\u002Fprednisolone or equivalent.\n3. Treatment with anti neoplastic therapy ≤ 28 days or ≤ 5× elimination half life, whichever is shorter, before the first dose of study drug.\n4. Major surgery requiring general anesthesia ≤ 28 days prior to dosing.\n5. History of permanent discontinuation of prior IO therapy due to irAE.\n6. Prior treatment targeting ILT2 and\u002For ILT4 or targeting HLA G.\n7. Live or live attenuated vaccine ≤ 28days prior to dosing.\n8. Immunosuppressive systemic medication, except topical corticosteroids or systemic corticosteroids at a dose level of ≤ 10 mg\u002Fd of prednisone\u002Fprednisolone or equivalent. Note: patients with adrenal insufficiency requiring hormonal replacement may receive higher dose of steroids.\n9. Prior solid organ or bone marrow transplantation (except cornea transplantation).\n10. History of clinically significant cardiovascular events (e.g. DVT ≤ 6 months, PE ≤ 12 months, MI or hospitalization for CHF ≤ 12 months, bleeding disorder or bleeding event ≤ 6 months, current clinically significant arrhythmia or unstable angina pectoris, current uncontrolled history of cerebrovascular accident in the past 6 months, current uncontrolled hypertension).",{"count":182,"type":20},232,[23],"Part 1 of this study is an open-label, dose-escalation, and safety expansion study of an anti-LILRB2 \u002F anti-PD-L1 bispecific antibody SPX- 303 in patients with solid tumors. Part 2 of this study is an indication-specific dose expansion study of SPX-303.",[186,143,28,141],"Solid Tumor",[186],"2024-09-20",{"date":190,"type":42},"2024-09-24",{"date":192,"type":42},"2024-03-20",{"date":46,"type":20},{"name":195,"class":75},"SparX Biotech(Jiangsu) Co., Ltd.",4,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":21,"phases":207,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":4},"100561109","a-prospective-registry-study-of-stereotactic-ablative-radiotherapy-sabr-for-oligometastaticoligometastatic-renal-cell-carcinoma-100561109","NCT06585878","A Prospective Registry Study of Stereotactic Ablative Radiotherapy (SABR) for Oligometastatic\u002FOligometastatic Renal Cell Carcinoma","Study on the Efficacy and Safety of Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients","Inclusion Criteria:\n\n* 1: Patients with newly diagnosed M1 renal cancer or those with oligoprogression during systemic therapy, with no restrictions on the location or number of metastatic sites, but all metastatic sites must be evaluated by the radiation oncology department as safely able to receive a radical radiation dose (α\u002Fβ value of 3, EQD2 ≥ 70Gy).\n\n  2: Age ≥ 18 years. 3: ECOG score of 0-3. 4: Confirmed renal malignancy by pathology or imaging examination, with no subtype restrictions.\n\n  5: Presence of evaluable lesions. 6: Patients with spinal cord compression or significant brain metastasis edema requiring surgical decompression can be enrolled after evaluation by the radiation oncology department if the aforementioned dose can be safely administered post-decompression.\n\n  7: Able to tolerate radiation therapy and standard systemic therapy (targeted therapy or targeted immunotherapy combination).\n\n  8: Expected survival \\> 6 months. 9: Able to sign the informed consent form. 10: Has conditions for follow-up.\n\nExclusion Criteria:\n\n* 1: Patients with other comorbidities that prevent the use or tolerance of targeted immunotherapy drugs, such as targeted immunotherapy drug allergies, active bleeding, ulcers, intestinal perforation, intestinal obstruction, uncontrolled hypertension, grade III-IV cardiac dysfunction (NYHA criteria), severe hepatic and renal insufficiency (grade IV), etc.\n\n  2: Patients with other comorbidities that prevent tolerance of radiation therapy.\n\n  3: Complete response to first-line drug therapy (i.e., no treatable targets for SABR).\n\n  4: Previous history of radiation therapy to the same site. 5: Pregnant or lactating women. 6: Patients with other severe medical comorbidities that prevent participation in the study.","75 Years",{"count":206,"type":20},60,[208],"NA","Study the efficacy and toxicity of SABR treatment for oligometastatic\u002Foligoprogressive renal cell carcinoma; investigate the effectiveness and safety of SABR combined with targeted immunotherapy; conduct stratified analysis to identify the optimal beneficiary population; establish a biobank to screen for biomarkers; and use radiomics analysis to identify characteristics of sensitive populations.",[27,28,37],[27,212,213,214,215],"Stereotactic Ablative Radiotherapy (SABR)","Systemic Treatment","Toxicity","Curative Effect","2024-09-03",{"date":218,"type":42},"2024-09-19",{"date":220,"type":20},"2024-09-01",{"date":222,"type":20},"2027-04-30",{"name":224,"class":75},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":202,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":204,"enrollmentInfo":231,"targetDuration":4,"studyType":21,"phases":233,"briefSummary":234,"conditions":235,"keywords":236,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":4},"100560501","phase-1-vorolanib-combined-with-cadonilimab-in-the-treatment-of-untreated-advanced-rcc-patients-100560501","NCT06577961","Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients","Inclusion Criteria:\n\n1. Subjects voluntarily participate in this study, willing and able to comply with and sign the informed consent form;\n2. Histologically confirmed clear cell renal cell carcinoma;\n3. Advanced (not suitable for curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC;\n4. No prior systemic treatment for RCC, except for the following situations:\n\n   a) For completely resectable renal cell carcinoma, having received one type of adjuvant or neoadjuvant treatment, if the treatment does not include drugs targeting VEGF or VEGFR, and recurrence occurs at least 6 months after the last adjuvant or neoadjuvant treatment;\n5. Confirmed to have at least one measurable lesion according to RECIST 1.1 criteria;\n6. KPS score ≥ 70;\n7. Expected survival time of more than 3 months;\n8. Aged 18-75 years;\n9. Good function of major organs and sufficient hematology, meeting the following criteria:\n\n   Absolute neutrophil count (ANC) ≥ 1500 cells\u002FμL (no granulocyte colony-stimulating factor support within 2 weeks before Cycle 1, Day 1) Platelet count (PLT) ≥ 80 × 10\\^9\u002FL. WBC count ≥ 2500\u002FμL without G-CSF, ≤ 15000\u002FμL Lymphocyte count ≥ 500\u002FμL Hemoglobin ≥ 9.0 g\u002FdL (Cycle 1), not dependent on erythropoietin, and no transfusion of concentrated red blood cells (pRBC) in the past 2 weeks Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤ 3 times the upper limit of normal (ULN) (liver metastasis ≤ 5 times ULN). If the patient has bone metastasis, ALP ≤ 5 times ULN.\n\n   Serum bilirubin ≤ 1.5 × ULN. Patients with known Gilbert's syndrome can be enrolled if serum bilirubin level ≤ 3 times ULN.\n\n   Serum albumin ≥ 2.8 g\u002FdL Creatinine ≤ 2.0 × ULN or calculated creatinine clearance rate ≥ 30 mL\u002Fmin. Urine protein\u002Fcreatinine ratio (UPCR) ≤ 1 mg\u002Fmg (≤ 113.2 mg\u002Fmmol)\n10. For women who are not menopausal (amenorrhea for 12 months) or surgically sterile (without ovaries and\u002For uterus): agree to use two appropriate methods of contraception, including at least one method with an annual failure rate of ≥ 1%.\n11. Sexually active subjects of childbearing potential and their partners must agree to use medically recognized contraceptive methods during the study and for 5 months after the last dose of study treatment for women and 7 months for men (e.g., barrier methods, including male condoms, female condoms, or diaphragms coated with spermicidal gel).\n12. Female subjects of childbearing potential must not be pregnant at screening. Women of childbearing potential are defined as premenopausal women who can become pregnant (i.e., women who have had any menstrual signs in the past 12 months, except for those who are surgically sterile as mentioned above).However, women who have been amenorrheic for 12 months or longer are still considered to have childbearing potential if the amenorrhea is likely due to previous chemotherapy, anti-estrogens, low body weight, ovarian suppression, or other reasons.\n\nExclusion Criteria:\n\n1. Received any systemic treatment for RCC, unless the investigator can provide evidence that the subject has been randomly assigned to the placebo group;\n2. Central nervous system metastasis;\n3. Active malignant tumor in the past 24 months (except for renal cell carcinoma, skin basal cell carcinoma or squamous cell carcinoma that has been clearly treated, as well as cervical or bladder carcinoma in situ). Participants with a history of localized and low-risk prostate cancer who have received curative treatment and have not had a prostate-specific antigen (PSA) recurrence in the past 5 years may participate in the study;\n4. Received prior radiotherapy within 21 days before the start of study treatment (palliative radiotherapy for bone lesions is allowed, provided it is completed at least 2 weeks before the start of study treatment);\n5. Currently participating in another study or received study drugs within 4 weeks before the start of study treatment.\n6. Receiving live vaccines within 30 days after the planned start of study treatment (first cycle\u002Fday 1). Live vaccines include but are not limited to measles, mumps, rubella, varicella\u002Fzoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Injectable seasonal influenza vaccines are generally inactivated virus vaccines and are allowed; however, intranasal influenza vaccines are attenuated live vaccines and are not allowed.\n7. Participants with proteinuria \\> 1+ on urine dipstick test will undergo a 24-hour urine collection for quantitative assessment of proteinuria. Participants with urinary protein ≥ 1g\u002F24h will not be eligible.\n8. Fasting total cholesterol \\> 300 mg\u002FdL (or 7.75 mmol\u002FL) and\u002For fasting triglyceride level 2.5 times the upper limit of normal (ULN). Note: These participants can be included after lipid-lowering treatment.\n9. Uncontrolled diabetes defined as fasting blood glucose \\> 1.5 times the upper limit of normal. Note: These participants can be included after hypoglycemic treatment.\n10. Uncontrolled hypercalcemia (≥ 1.5 mmol\u002FL ionized calcium or Ca ≥ 12 mg\u002FdL or corrected serum calcium ≥ ULN) or symptomatic hypercalcemia requiring continued bisphosphonate treatment or denosumab.\n11. QTc interval prolongation to \\> 480 ms.\n12. Participants who have not fully recovered from any toxicity and\u002For complications caused by major surgery before starting treatment.\n13. Malabsorption, gastrointestinal anastomosis, or any other condition that may affect the absorption of study drugs.\n14. Clinically significant hematuria, vomiting blood, or coughing up blood \\> 0.5 teaspoon (2.5 ml) within 12 weeks before the first dose, or other significant bleeding history (such as pulmonary hemorrhage).\n15. Significant cardiovascular impairment within 12 months after the first dose of study drug: history of congestive heart failure New York Heart Association class II or higher, unstable angina, myocardial infarction, cerebrovascular accident, or arrhythmia related to hemodynamic instability. The following conditions are also excluded: left ventricular ejection fraction (LVEF) below the institutional normal range determined by gated blood pool scan or echocardiogram.\n16. Active infection (any infection requiring systemic treatment).\n17. Positive for human immunodeficiency virus (HIV).\n18. Active hepatitis B or C.\n19. Known history of interstitial lung disease or any evidence.\n20. History of (non-infectious) pneumonia requiring steroids, or currently suffering from pneumonia.\n21. Diagnosed with immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first study treatment. Physiological doses of corticosteroids (up to 10 mg\u002Fday prednisone or equivalent) can be used during the study period.\n22. Active autoimmune disease requiring systemic treatment within the past 2 years (excluding psoriasis). Alternative therapies (such as thyroid hormones, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered forms of systemic treatment.\n23. Breastfeeding or pregnant women at screening or baseline.\n24. Fertile women who do not agree to use highly effective contraceptive methods throughout the study period and for 120 days after the end of the study.\n25. Men who have not successfully undergone vasectomy (diagnosed with azoospermia) and do not agree to use condoms\u002Fspermicides from the first dose of study treatment until 120 days after the last dose of study treatment, unless they practice abstinence.\n26. Known intolerance to any study drug (or any excipient).\n27. Participants who have received allogeneic tissue\u002Fsolid organ transplantation.\n28. Patients requiring pain medication must be on a stable treatment regimen at the start of the study.\n29. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (monthly or more frequently).\n30. Uncontrolled hypertension defined as persistent blood pressure (BP) \\> 150 mmHg systolic or \\> 100 mmHg diastolic.\n31. Unable to swallow tablets or capsules.",{"count":232,"type":20},37,[23,109],"Evaluate the efficacy and safety of vorolanib combined with cadonilimab in the treatment of untreated advanced RCC patients.",[37,28,27],[37,28,27,237],"vorolanib Combined with Cadonilimab","2024-08-27",{"date":240,"type":42},"2024-08-29",{"date":242,"type":20},"2024-08-31",{"date":244,"type":20},"2027-08-31",{"name":224,"class":75}]