[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clear-cell-renal-cell-carcinoma-ccrcc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clear-cell-renal-cell-carcinoma-ccrcc":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,42,67,97,138,165,197,224,250],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100607464","phase-2-a-randomized-trial-of-fianlimab-and-cemiplimab---ipilimumab-or-ipilimumab-plus-nivolumab-in-first-line-advanced-renal-cell-carcinoma-rcc-100607464",false,"NCT07188896","A Randomized Trial of Fianlimab and Cemiplimab +\u002F- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)","A Randomized Phase 2 Trial of Fianlimab and Cemiplimab +\u002F- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)","Inclusion Criteria:\n\n1. Signed informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky Performance Status ≥ 70% within 14 days prior to registration.\n4. Histological or cytological evidence of renal cell carcinoma having a clear cell component\n5. Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV \\[version 9\\]) renal cell carcinoma.\n6. Treatment naïve for systemic therapy for renal cell carcinoma including no prior neo\u002Fadjuvant systemic therapy\n7. Measurable disease according to RECIST 1.1 within 28 days prior to registration.\n8. Patient must have either a formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tumor tissue sections, obtained from preferably a metastatic lesion, preferably within 3 months or no more than 12 months with an associated pathology report. If the metastatic lesion biopsy specimen does not contain at least 20 unstained slides, supplementation with primary kidney cancer tissue is acceptable.\n9. Demonstrate adequate organ function as defined in the protocol. All screening labs to be obtained within 14 days prior to registration.\n10. Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration.\n11. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from penile-vaginal intercourse or must use an effective method(s) of contraception. Males able to father a child who are sexually active with a female of childbearing potential must be willing to abstain from penile-vaginal intercourse or use an effective method(s) of contraception.\n12. Known HIV-infected subjects on effective anti-retroviral therapy with undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen within 6 months of registration are eligible for this trial. Testing is not required at screening unless mandated by local policy\n13. Subjects with known chronic hepatitis B virus (HBV) infection, must have an undetectable HBV viral load (serum hepatitis B virus DNA PCR that is below the limit of detection) and be on suppressive therapy, if indicated.\n14. Subjects with a history of hepatitis C virus (HCV) infection must have been treated and cured (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy). For subjects with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Testing is not required at screening unless mandated by local policy.\n15. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n1. Prior systemic therapy against renal cell carcinoma in the neo\u002Fadjuvant or metastatic setting\n2. Any condition requiring ongoing ≥ 10 mg prednisone equivalent\u002Fday\n3. Participants with a history of myocarditis.\n4. If clinically indicated based on clinical assessment and any ECG abnormalities, optional troponin T (TnT) or troponin I (TnI) may be done as described in the protocol.\n5. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are allowed: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.\n6. Central nervous system (CNS) metastases as described in the protocol.\n7. Active infection requiring systemic therapy as described in the protocol.\n8. Pregnant or breastfeeding as described in the protocol.\n9. Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion.\n10. Subjects must not receive live attenuated vaccines within 4 weeks prior to Cycle 1 Day 1 or at any time during the study. Inactivated vaccines are allowed.\n11. Known hypersensitivity to the active substances or to any of the excipients.\n12. Currently participating in another study or participated in any study of an investigational agent or investigational device within 30 days of the first dose of study drug.","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This three-arm randomized phase 2 trial will enroll advanced clear cell RCC patients (all IMDC risk groups). Patients will be randomized 2:2:1 to either Arm A (fianlimab\u002F cemiplimab\u002F ipilimumab), Arm B (fianlimab\u002F cemiplimab), or Arm C (standard ipilimumab\u002F nivolumab), respectively.",[26,27,28],"Advanced Renal Cell Carcinoma (aRCC)","Metastatic Renal Cell Carcinoma ( mRCC)","Clear Cell Renal Cell Carcinoma (ccRCC)","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2026-04-29",{"date":37,"type":20},"2030-11-30",{"name":39,"class":40},"Brian Rini","OTHER",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100360402","phase-1-a-trial-to-find-out-if-regn5678-nezastomig-is-safe-and-how-well-it-works-alone-or-in-combination-with-cemiplimab-for-adult-participants-with-metastatic-castration-resistant-prostate-cancer-and-other-tumors-100360402","NCT03972657","A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors","A Phase 1\u002F2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression","Key Inclusion Criteria:\n\nmCRPC cohorts (men):\n\n1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.\n2. PSA value at screening ≥4 ng\u002FmL that has progressed within 6 months prior to screening as defined in the protocol.\n3. Has received ≥2 lines prior systemic therapy approved in the metastatic and\u002For castration-resistant setting (in addition to Androgen Deprivation Therapy \\[ADT\\]) including at least:\n\n   1. one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)\n   2. 177Lu-PSMA-617 radiotherapy, or another lutetium-based PSMA targeted radioligand, as described in the protocol\n\nccRCC cohorts (men and women):\n\n1. Histologically or cytologically confirmed RCC with a clear-cell component.\n2. Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria\n3. Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-Programmed Death-1 (receptor) \\[PD-1\\]\u002FProgrammed Death-Ligand 1 (PD-L1) therapy and either ipilimumab and\u002For a tyrosine kinase inhibitor\n\nKey Exclusion Criteria:\n\n1. Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities, as described in the protocol\n2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol\n3. Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC\n4. Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.\n5. Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol\n6. Any condition that requires ongoing\u002Fcontinuous corticosteroid therapy (\\>10 mg prednisone\u002Fday or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy\n7. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, as described in the protocol\n8. Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with Activities of Daily Living \\[ADLs\\]) or uncontrolled seizures in the year prior to first dose of study therapy\n9. Uncontrolled infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency\n\nNOTE: Other protocol defined Inclusion\u002FExclusion Criteria apply",{"count":50,"type":20},345,[52,23],"PHASE1","The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\\[s\\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab.\n\nThe study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.\n\nThis study is looking at several other research questions, including:\n\n1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab\n2. How REGN5678 alone or in combination with cemiplimab works in the body\n3. How much REGN5678 and\u002For cemiplimab are present in the blood\n4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor",[55,28],"Metastatic Castration-Resistant Prostate Cancer (mCRPC)","2026-06-22",{"date":58,"type":33},"2026-06-25",{"date":60,"type":33},"2019-08-12",{"date":62,"type":20},"2027-11-15",{"name":64,"class":65},"Regeneron Pharmaceuticals","INDUSTRY",22,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100452820","phase-1-study-of-zanzalintinib-in-combination-with-immuno-oncology-agents-in-participants-with-solid-tumors-100452820","NCT05176483","Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors","A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors","STELLAR-002","Key Inclusion Criteria:\n\n* Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.\n* Dose-Escalation Cohorts: Participants with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.\n* Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy.\n\n  * Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose.\n* Expansion Cohort 2 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component.\n\n  * Must have radiographically progressed after a combination therapy consisting of a Programmed Cell Death Protein 1 (PD-1)\u002FProgrammed death-ligand 1 (PD-L1) targeting monoclonal antibody (mAb) with a Vascular endothelial growth factor (receptor) tyrosine kinase inhibitor (VEGFR-TKI) or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy.\n  * Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma.\n* Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate.\n\n  * Must have progressed during or after one novel hormone therapy (NHT) given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC.\n* Expansion Cohort 4 (UC, ICI-naive): Participants with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).\n\n  * Must have progressed during or after prior first-line platinum-based combination therapy, including participants who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence \\\u003C 12 months from the end of last therapy.\n  * Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease.\n* Expansion Cohort 5 (post enfortumab vedotin \\[EV\\] and ICI): Participants with histologically confirmed unresectable, locally advanced or metastatic predominant urothelial carcinoma.\n\n  * Progressive disease following prior EV or ineligible for EV, and progression following prior PD-1\u002FPD-L1 inhibitor or ineligible for PD-1\u002FPD-L1 inhibitor.\n  * Prior receipt of platinum-based therapy allowed but not required.\n  * Prior therapy with other agents allowed but not required.\n* Expansion Cohort 6 (nccRCC): Participants with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary, unclassified RCC, and translocation-associated, Fumarate Hydratase (FH) deficient and Succinate Dehydrogenase (SDH) deficient. Among the eligible histologic subtypes, sarcomatoid features are allowed.\n\n  * No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose.\n* Expansion Cohort 7 (HCC): Participants with locally advanced, or metastatic and\u002For unresectable HCC that is not amenable to curative treatment or locoregional therapy.\n* Expansion Cohort 8 (NSCLC): Participants with Stage IV non-squamous NSCLC with positive PD-L1 expression (tumor proportion score \\[TPS\\] 1-49%) and without prior systemic anticancer therapy for metastatic disease.\n* Expansion Cohort 9 (NSCLC): Participants with Stage IV non-squamous NSCLC who have radiologically progressed following treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease.\n* Expansion Cohort 10 (CRC): Participants with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum.\n* Expansion Cohort 11 (HNSCC): Participant with inoperable, refractory, recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx. PD-L1 combined positive score (CPS) ≥1.\n* Expansion Cohort 12 (ccRCC): Participants with unresectable advance or metastatic RCC with a clear cell component, including participants who also have a sacromatoid feature.\n\n  * Must have received no more than two prior lines of systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma\n* Expansion Cohort 13 and Cohort 14 (ccRCC 1L): Participants with unresectable advanced or metastatic RCC with a clear component, including participants who also have a sacromatoid feature.\n* For all Expansion Cohorts except Cohort 3: Measurable disease per RECIST 1.1 as determined by the Investigator.\n* For Expansion Cohorts 1 - 11 Only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.\n* Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and\u002For stable on supportive therapy.\n* Karnofsky Performance Status (KPS) ≥ 70%.\n* Adequate organ and marrow function.\n* Sexually active fertile participants and their partners must agree to use highly effective methods of contraception.\n* Females of childbearing potential must not be pregnant at screening.\n\nKey Exclusion Criteria:\n\n* For all Dose-Escalation cohorts: Prior treatment with zanzalintinib. For all Expansion Cohorts: Prior treatment with zanzalintinib, nivolumab, ipilimumab or relatlimab with the following exceptions: Prior PD-1\u002FPD-L1, Lymphocyte-activation gene 3 (LAG-3) and cCytotoxic T lymphocyte associated protein 4 (CTLA-4) targeting therapy for locally advanced or metastatic disease is allowed for Cohort 2 (ccRCC), Cohort 5 (UC), Cohort 9 (NSCLC), and Cohort 12 (ccRCC), and prior treatment in the neoadjuvant or adjuvant setting is allowed for Cohort 13 and Cohort 14 (ccRCC 1L).\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC), Cohort 10 (CRC), and Cohort 12: Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC), and Cohort 12: Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment.\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* Prior external radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment, unless otherwise specified.\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.\n* Concomitant anticoagulation with oral anticoagulants, except for specified direct factor Xa inhibitors.\n* Administration of a live, attenuated vaccine within 30 days prior to first dose.\n* Uncontrolled, significant intercurrent or recent illness.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 460 ms for females and \\> 450 ms for males per electrocardiogram (ECG) within 14 days before first dose of study treatment.\n* Participants with inadequately treated adrenal insufficiency.\n* Pregnant or lactating females.\n* Any other active malignancy within two years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* For Cohort 2 (ccRCC, 2L): Receipt of a prior triplet therapy including a VEGFR-TKI, a PD1 targeting mAb, and a CTLA-4 mAb.\n* For Cohort 3 (mCRPC): Receipt of a taxane-based chemotherapy for mCRPC.\n* For Cohort 4 (UC, ICI-naïve): Participants who have had recurrence within the 6 months of completing adjuvant anti-PD-(L)1 treatment.\n* For Cohort 6 (nccRCC, 1L): Participants with chromophobe, renal medullary carcinoma, or pure collecting duct nccRCC.\n* For Cohort 7 (HCC):\n\n  * Documented hepatic encephalopathy (HE) within 6 months before the first dose.\n  * Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization.\n  * Participants who have received any local anticancer therapy including surgery, percutaneous ethanol injection (PEI), radiofrequency ablation (RFA), microwave ablation (MWA), transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to first dose.\n  * Participants with known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma\n* For Cohort 10 (CRC, 2L+): Receipt of prior therapy with regorafenib and\u002For trifluridine + tipiracil (TAS-102).\n* For Cohort 11 (HNSCC): Primary tumor site of the nasopharyngeal area.\n* For Cohorts 1 (ccRCC, 1L), 2 (ccRCC, 2L), 4, 5 (UC), 7 (HCC), 8 (NSCLC 1L PD-L1 low), 9 (NSCLC, 2L+), 10 (CRC, microsatellite stable \\[MSS\\], 2L+), and 11 (HNSCC):\n\n  * Troponin T (TnT) or I (TnI) \\> 2 × institutional upper limit of normal (ULN).\n\nNote: Additional Inclusion and Exclusion criteria may apply.",{"count":76,"type":20},1314,[52],"This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors.\n\nIn the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.",[80,55,81,82,83,84,85,86,28,87],"Renal Cell Carcinoma (RCC)","Urothelial Carcinoma (UC)","Solid Tumor","Hepatocellular Carcinoma (HCC)","Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","Non-Clear Cell Renal Cell Carcinoma (nccRCC)","2026-06-17",{"date":56,"type":33},{"date":91,"type":33},"2021-12-14",{"date":93,"type":20},"2030-06-28",{"name":95,"class":65},"Exelixis",122,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":115,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100518120","phase-1-ko-2806-monotherapy-and-combination-therapies-in-advanced-solid-tumors-100518120","NCT06026410","KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors","Phase 1, First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of KO-2806 When Administered as Monotherapy and in Combination Therapy in Adult Patients With Advanced Solid Tumors","FIT-001","Inclusion Criteria:\n\n* At least 18 years of age.\n* Histologically or cytologically confirmed advanced solid tumors\n\n  * Arm #1 (KO-2806 monotherapy): Patients who have progressed on, or are refractory to, standard of care (SOC) treatments with advanced solid tumors, specifically: HRAS-mutant and\u002For amplified tumors (any solid tumor type); HRAS overexpression (only for HNSCC tumors); KRAS and\u002For NRAS, and\u002For HRAS-mutant and\u002For amplified NSCLC or CRC; KRAS-mutant and\u002For amplified PDAC\n  * Arm #2 (Combination): Patients who have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC with predominantly clear cell subtype; non-clear cell RCC patients who are either treatment-naïve or have received any prior systemic treatment for locally advanced and metastatic RCC.\n  * Arm #3 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally advanced or metastatic NSCLC, CRC, or PDAC.\n  * Arm #4 (Combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.\n  * Arm #5 (Cabozantinib monotherapy): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.\n  * Arm #6 (Cabozantinib rollover to combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.\n  * Arm #7 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally advanced or metastatic NSCLC\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Karnofsky Performance Status of 70 or higher with no clinically significant deterioration over the previous 2 weeks.\n* Acceptable liver, renal, endocrine, and hematologic function.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any use of anticancer therapy within 14 days or 5 half-lives (whichever is shorter) of Cycle 1 Day 1.\n* Prior treatment with an FTI or HRAS inhibitor.\n* Major surgery, other than local procedures, within 28 days prior to Cycle 1 Day 1, without complete recovery.\n* Spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.\n* Toxicity (excluding alopecia) from prior therapy that has not been completely resolved to baseline at the time of consent.\n* Active or prior documented autoimmune or inflammatory disorders within the past 5 years prior to Cycle 1 Day 1 (with exceptions).\n* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.\n* Inability to swallow, impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the trial drugs.\n* Inadequate cardiac and\u002For vascular function, including receipt of treatment for unstable angina, myocardial infarction, and\u002For cerebrovascular attack within the prior 6 months, mean QTcF ≥470 ms, or Class II or greater congestive heart failure.\n* Other invasive malignancy within 2 years.\n* Other protocol-defined exclusion criteria may apply.",{"count":106,"type":20},300,[52],"This first-in-human (FIH) dose-escalation and dose-validation\u002Fexpansion study will assess KO-2806, a farnesyltransferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.",[110,111,85,112,28,113,114],"Solid Tumors With HRAS Alterations","Non Small Cell Lung Cancer (NSCLC)","Pancreatic Ductal Adenocarcinoma (PDAC)","Renal Cell Carcinoma (Kidney Cancer)","Non Clear Cell Renal Cell Carcinoma (nccRCC)",[116,117,118,119,120,121,122,123,124,125,126,127],"HRAS","KRAS","NRAS","Farnesyltransferase inhibitor (FTI)","Tyrosine Kinase inhibitor (TKI)","Phase 1","KRAS G12C inhibitor","NSCLC","ccRCC","RCC","PDAC","CRC","2026-06-04",{"date":130,"type":33},"2026-06-08",{"date":132,"type":33},"2023-10-18",{"date":134,"type":20},"2027-04",{"name":136,"class":65},"Kura Oncology, Inc.",38,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":156,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":4},"100637297","phase-1-regn15505-psmax4-1bb-alone-or-in-combination-with-cemiplimab-or-regn4336-psmaxcd3-in-adult-patients-with-metastatic-castration-resistant-prostate-cancer-and-clear-cell-renal-cell-carcinoma-100637297","NCT07594106","REGN15505 (PSMAx4-1BB) Alone or in Combination With Cemiplimab or REGN4336 (PSMAxCD3) in Adult Patients With Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma","Phase 1\u002F2 Study of REGN15505 (a PSMAx4-1BB Bispecific Antibody) Administered Alone or in Combination With Cemiplimab or REGN4336 (a PSMAxCD3 Bispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma","Key Inclusion Criteria:\n\nParticipants with mCRPC:\n\n1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma\n2. mCRPC with PSA value at screening ≥4 ng\u002FmL and that has progressed within 6 months prior to screening as described in the protocol\n3. Has received ≥2 lines of prior systemic therapy approved in the metastatic and\u002For castration-resistant setting as described in the protocol\n4. Have had either Orchiectomy or be on Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist therapy with serum testosterone \\\u003C50 ng\u002FdL AND agree to stay on LHRH agonist or antagonist therapy during the study\n\n   Participants with ccRCC:\n5. Men and women with histologically or cytologically confirmed Renal Cell Carcinoma (RCC) with a clear-cell component\n6. Diagnosis of metastatic ccRCC with at least 1 measurable lesion via Response evaluation criteria in solid tumors (RECIST) 1.1 criteria\n7. Has progressed on or after ≥1 line of prior systemic therapy approved in the metastatic setting. Prior treatment must include an Anti Program Cell Death 1 (PD-1)\u002F Program Death Ligand 1 (PD-L1) therapy and either ipilimumab and\u002For a Tyrosine Kinase Inhibitor (TKI)\n\nKey Exclusion Criteria:\n\nFor Both mCRPC and ccRCC Cohorts:\n\n1. Has received treatment with an approved systemic therapy (including sipuleucel-T for mCRPC patients) within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities except for laboratory changes as described in the protocol\n\n   mCRPC Cohort Only:\n2. Has received prior Prostate Specific Membrane Antigen (PSMA)-targeting therapy with the exception of a PSMA-targeting radioligand (eg, 177Lu-PSMA-617)\n\nNote: Other protocol defined inclusion\u002Fexclusion criteria apply",{"count":146,"type":20},265,[52,23],"This study is researching a new drug called REGN15505 when used alone or in combination with cemiplimab or in combination with REGN4336 in adult patients with mCRPC and ccRCC. The goal is to explore new ways to treat these cancers by helping immune cells target and destroy cancer cells.\n\nThe study will evaluate the use of REGN15505 when administered alone, in combination with cemiplimab, or in combination with REGN4336 for:\n\n* Any side effects of study drugs\n* How well the study drugs work\n* How much REGN15505, cemiplimab, and REGN4336 are in the blood at different times\n* If the body makes antibodies to REGN15505 or REGN4336, which may mean the study drugs will not work as well as expected\n* What is the best dose of REGN15505 when administered alone and with cemiplimab and the best dose of REGN15505 and REGN4336 when used in combination",[55,28],[151,152,153,154,155],"Cemiplimab","PSMA","REGN4336","REGN15505","4-1BB","NOT_YET_RECRUITING","2026-05-11",{"date":159,"type":33},"2026-05-18",{"date":161,"type":20},"2026-05-25",{"date":163,"type":20},"2030-09-20",{"name":64,"class":65},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":181,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},"100547877","phase-1-a-first-in-human-fih-study-to-find-out-how-well-regn10597-medicine-given-alone-or-in-combination-with-cemiplimab-works-in-adult-participants-who-have-cancer-with-tumors-that-have-spread-in-their-body-100547877","NCT06413680","A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body","A Phase 1\u002F2a, Open-Label, Dose Escalation and Dose Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti-PD-1-IL-2RA-IL-2 Fusion Protein) Alone or in Combination With Cemiplimab in Patients With Advanced Solid Organ Malignancies","BrILliance","Key Inclusion Criteria:\n\nDose escalation cohorts:\n\n1\\. Histologically or cytologically confirmed diagnosis of solid malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy. Participants are required to submit archival tissue if it is available\n\nDose expansion cohorts:\n\n1\\. Histologically of cytologically confirmed diagnosis of one of the following tumors with criteria, as defined in the protocol:\n\n* Module 1, Cohort 1: anti-PD-(L)1 Progressed Melanoma or\n* Module 1, Cohort 2: anti-PD-(L)1 Progressed RCC or\n* Module 2, Cohort 1: 1L Melanoma ALL Participants ARE REQUIRED to submit fresh pretreatment biopsy during screening, with an additional exploratory biopsy at other time points\n\nKey Exclusion Criteria:\n\n1. Prior treatment with Interleukin 2 (IL2)\u002FIL15\u002FIL-7 given outside the context of concurrent administration with adoptive cell therapy\n2. Prior treatment with anti-PD1\u002FPD-L1, or an approved systemic therapy or any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocol\n3. Has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEs\n4. Has had prior anti-cancer immunotherapy within 4 weeks prior to study intervention, or discontinuation of prior anti-cancer immunotherapy due to grade 3 or 4 toxicities\n5. Has ongoing immune-related AEs prior to initiation of study intervention, as defined in the protocol\n6. Has known allergy or hypersensitivity to components of the study drug(s)\n7. Has any condition requiring ongoing\u002Fcontinuous corticosteroid therapy (\\>10 mg prednisone\u002Fday or anti-inflammatory equivalent) within 1-2 weeks to the first dose of study intervention\n8. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments\n\nNOTE: Other Protocol Defined Inclusion \u002F Exclusion Criteria Apply.",{"count":174,"type":20},240,[52,23],"This study is researching an experimental drug called REGN10597 alone or in combination with another drug called cemiplimab (called \"study drug(s)\"). The study is focused on patients with certain solid tumors that are in an advanced stage.\n\nThe aim of the study is to see how safe, tolerable, and effective the study drug(s) are.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug(s)\n* How much study drug(s) is in the blood at different times\n* Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)",[178,179,180],"Melanoma","Clear-Cell Renal-Cell Carcinoma (ccRCC)","Advanced Solid Tumors",[182,183,184,185,186,187],"Advanced solid organ malignancies","Locally advanced","Metastatic","Non-uveal","Unresectable","Primary or secondary resistance to programmed cell death protein 1 (PD-1)\u002F programmed cell death ligand 1 (PD-L1)","2026-04-24",{"date":190,"type":33},"2026-04-28",{"date":192,"type":33},"2024-09-23",{"date":194,"type":20},"2030-02-03",{"name":64,"class":65},11,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":21,"phases":207,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":156,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":223},"100598868","phase-2-caix-petct-for-residual-or-recurrent-post-ablative-ccrcc-100598868","NCT07077083","CAIX PET\u002FCT for Residual or Recurrent Post-ablative ccRCC","A Pilot Study of 89Zr-girentuximab for PET Imaging in Residual or Recurrent Post Ablative Tumors in Patients With Renal Cell Carcinoma.","CAIX PET\u002FCT","Inclusion Criteria:\n\n1. Written and voluntarily given Informed Consent\n2. ≥18 years of age at time of consent\n\n   a. Because no dosing or adverse event data are currently available on the use of 89Zr-girentuximab in participants \\\u003C18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n3. Have the capacity to understand the study and be willing and able to comply with all protocol requirements.\n4. Findings suspicious for post-ablation residual or recurrent ccRCC (subjects in cohort 1) documented at conventional imaging or biopsy, performed within 90 days prior to 89Zr-girentuximab PET scan.\n5. Findings suspicious for primary ccRCC (subjects in cohort 2) documented at standard histology or conventional imaging, performed within 90 days prior to 89Zr-girentuximab PET scan.\n6. Negative serum or urine pregnancy tests in female patients of childbearing potential within 72 hours prior to receiving 89Zr-girentuximab. Female patients of non-child bearing potential must provide evidence by fulfilling one of the following criteria at screening:\n\n   1. Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\n   2. Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution\n   3. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation\n7. For all participants, consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-girentuximab administration.\n\nExclusion Criteria:\n\n1. Renal mass known to be a metastasis of another primary tumor.\n2. Active non-renal malignancy requiring therapy during and up to EOT visit.\n3. Planned antineoplastic therapies (for the period between IV administration of 89Zr-girentuximab and imaging).\n4. Previous administration of any radionuclide within 10 of its half-lives before 89Zr-girentuximab injection day.\n5. Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic), that may interfere with the objectives of the program or with the safety or compliance of the subject, as judged by the Investigator.\n6. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the program.\n7. Women who are pregnant or breastfeeding.\n8. Known hypersensitivity to girentuximab or DFO (desferoxamine).\n9. Renal insufficiency with estimated glomerular filtration rate eGFR ≤ 40 mL\u002Fmin\u002F 1.73 m²",{"count":206,"type":20},10,[23],"The goal of this clinical trial is to learn whether 89Zr-Girentuximab PET scans can inform management of renal cell carcinoma. The main questions it aims to answer are:\n\n* Does the 89Zr-Girentuximab PET detect ccRCC that is left behind or has come back after treatment?\n* What differences can be seen on the 89Zr-Girentuximab PET before and after standard of care treatment?\n\nParticipants in arm 1 will be given the study drug followed by a PET scan 3-7 days after injection. Participants in arm 2 will receive the same, but will proceed with their standard of care cryoablation after the initial PET scan. Within 3 days of the cryoablation treatment, participants will receive a repeat PET scan.",[28,124],[211,212,213],"kidney","kidney cancer","imaging","2026-03-09",{"date":216,"type":33},"2026-03-11",{"date":218,"type":20},"2026-03-16",{"date":220,"type":20},"2028-08-01",{"name":222,"class":40},"Massachusetts General Hospital",1,{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":21,"phases":234,"briefSummary":235,"conditions":236,"keywords":239,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":223},"100622633","phase-2-pucotenlimab-combination-with-vorolanib-as-neoadjuvant-therapy-for-ccrcc-100622633","NCT07386158","Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC","Phase II Single-arm Clinical Study of the Efficacy and Safety of Pucotenlimab in Combination With Vorolanib Neoadjuvant Therapy for Patients With High-risk Renal Carcinoma Indicating Partial Nephrectomy","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form (ICF).\n2. Age at the time of enrollment is between 18 years old and 85 years old, regardless of gender.\n3. The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1.\n4. Expected survival period ≥ 3 months.\n5. Preoperative biopsy pathology confirms renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma\n6. ECOG score 0 or 1\n7. The patient is willing to undergo kidney preservation surgery\n8. Preoperative assessment of healthy kidney GFR\\\u003C60 ml\u002Fmin through renal dynamic imaging\n9. There are indications for kidney preservation surgery, but the surgery is difficult \\[① 4-7cm tumor located at the renal hilum or endogenous ≥ 75% (T1bN0M0); ② Tumors larger than 7cm (T2N0M0)\\] 9. There should be at least one measurable lesion (according to mRECIST v1.1 criteria) that is suitable for repeated and accurate measurements.\n10. Good organ function, laboratory test results during the screening period meet the following criteria:\n\n\u003C!-- -->\n\n1. Hematology (no blood components or cell growth factors are allowed to support treatment within 2 weeks before starting treatment):\n\n   a. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL (1500\u002Fmm3); b. Platelet count (PLT) ≥ 100 × 109\u002FL (100000\u002Fmm3); c. Hemoglobin (HB) ≥ 90 g\u002FL;\n2. Liver:\n\n   1. Serum total bilirubin (TBIL) ≤ 1.5 × ULN;\n   2. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT ≤ 5 × ULN\n   3. Serum albumin (ALB) ≥ 28g\u002FL\n3. Coagulation function:\n\n   International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN 11. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study.\n\n   Exclusion Criteria:\n\n   • Renal vein cancer thrombus\n\n   • Diffuse tumor growth, with no clear boundary from normal renal parenchyma\n\n   • General poor condition, anesthesia assessment cannot tolerate general anesthesia surgery\n\n   • Have serious cardiovascular and cerebrovascular diseases, uncontrollable\n\n   • hypertension and diabetes\n\n   • Patients who have long-term use of immunosuppressants after organ transplantation\n\n   • Patients who are currently using immunosuppressive drugs\n\n   • Patients with clear infection or fever\n\n   • Patients with T-cell lymphoma and myeloma\n\n   • Patients who have concurrent malignant tumors, are currently undergoing treatment for other benign or malignant tumors, or have a history of other malignant tumors within the past six months\n\n   • Metastatic renal cell carcinoma.\n\n   • Received Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications within 14 days prior to the first use of the investigational drug\n\n   • Perform systematic treatment (including thymosin, interferon, interleukin, except for local use to control pleural effusion).\n\n   • Suffering from active or potentially recurrent autoimmune diseases, except for vitiligo, hair loss, psoriasis, or eczema that do not require systemic treatment; Hypothyroidism caused by autoimmune thyroiditis only requires stable doses of hormone replacement therapy; Type I diabetes requiring only a stable dose of insulin replacement therapy.\n\n   • Simultaneously enrolled in another clinical study, unless it is an observational, non interventional clinical study or a follow-up period of an interventional study.\n\n   Known history of mental illness, drug abuse, alcoholism, or drug use.\n   * Pregnant or lactating women.\n   * Any past or current illness, treatment, or laboratory test abnormalities may confuse the research results, affect the full participation of the subjects in the study, or participation in the study may not be in the best interests of the subjects.","85 Years",{"count":233,"type":20},21,[23],"Through the neoadjuvant treatment with a combination of Pucotenlimab and Vorolanib, it enabled the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who had indications for nephron-sparing surgery but faced considerable difficulty in preserving the kidney (T1b with an endophytic component ≥75% or T2)",[237,28,238],"Vorolanib","Neoadjuvant Therapy",[237,28,240],"Neoadjuvant therapy","2026-01-28",{"date":243,"type":33},"2026-02-04",{"date":245,"type":33},"2025-07-10",{"date":247,"type":20},"2026-12-31",{"name":249,"class":40},"Sun Yat-sen University",{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":259,"phases":4,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":223},"100586534","multicenter-study-of-18f-labeled-ny104-for-petct-imaging-in-renal-cell-carcinoma-100586534","NCT06916624","Multicenter Study of 18F-Labeled NY104 for PET\u002FCT Imaging in Renal Cell Carcinoma","Inclusion Criteria:\n\n* (1)Capable of understanding and voluntarily signing the informed consent form; able to complete the trial in accordance with the protocol requirements; (2)Age 18-75 years; no gender restrictions; (3)Clinically diagnosed\u002Fsuspected as renal cell carcinoma or clinically diagnosed\u002Fsuspected recurrence\u002Fmetastasis after RCC treatment; (4)At least 1 measurable solid lesion in the subject, which can be accurately and continuously measured using modified RECIST criteria (version 1.1); (5)ECOG performance status score of 0-2; (6)Laboratory parameters must meet:\n\n  1. Hematology: WBC ≥4.0×10⁹\u002FL or neutrophils ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL, Hb ≥90g\u002FL; PT or APTT ≤1.5×ULN (upper limit of normal);\n  2. Liver and kidney function: T-Bil ≤1.5×ULN, ALT\u002FAST ≤2.5×ULN or ≤5×ULN (for subjects with liver metastasis), ALP ≤2.5×ULN (if bone or liver metastasis present, ALP ≤4.5×ULN); BUN ≤1.5×ULN, SCr ≤1.5×ULN;\n  3. Other routine tests within normal ranges or deemed acceptable by the investigator; (7)Expected survival ≥12 weeks; (8) Female subjects: Effective contraception (defined as sterilization, intrauterine hormone device, condoms, contraceptives\u002Fagents, abstinence, or partner vasectomy) must be used during the study and for 6 months post-study; Male subjects: Agreement to use contraception during the study and for 6 months post-study.\n\nExclusion Criteria:\n\n1. Recovery from major trauma (including surgery) within 4 weeks prior to study examination;\n2. Patients with systemic or local severe infections or other serious comorbidities;\n3. Severe hepatic or renal dysfunction;\n4. Refusal to participate in this clinical study;\n5. Patients with a history of allergy to any component of the imaging agent (including antibodies) or allergic constitution;\n6. Childbearing-aged male or female subjects who cannot adopt effective contraception;\n7. Women planning pregnancy, currently pregnant, or lactating;\n8. Patients unable or unwilling to undergo PET\u002FCT scanning;\n9. Other subjects deemed ineligible by the investigator.","75 Years",{"count":258,"type":20},40,"OBSERVATIONAL","Study on the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-NY104 PET\u002FCT in diagnosing primary, recurrent, and metastatic lesions of renal cell carcinoma; and investigate the effect of oral low-dose CAIX inhibitor (Acetazolamide) on the tissue distribution of 18F-NY104 in renal cell carcinoma patients, particularly in the stomach and kidneys.",[80,28],"2025-04-27",{"date":264,"type":33},"2025-04-29",{"date":266,"type":33},"2025-04-12",{"date":268,"type":20},"2026-12",{"name":270,"class":40},"The Affiliated Hospital of Qingdao University"]