[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colorectal-cancer-crc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colorectal-cancer-crc":32},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,73,0,25,[9,55,90,120,151,177,198,232,265,299,320,353,382,411,431,454,477,498,525,554,586,611,635,667,689],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100623492","phase-1-study-of-rason-inhibitors-in-combination-with-ivonescimab-in-patients-with-solid-tumors-100623492",false,"NCT07397338","Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors","A Phase 1\u002F2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With Solid Tumors","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS.\n* Received and progressed or been intolerant to prior standard therapy (Part 1 Dose Exploration).\n* Non-squamous NSCLC without a treatable driver mutation in other oncogenes that has not received prior systemic treatment (Arms A \\& B for Part 2 Dose Expansion).\n* Solid tumor or CRC previously treated with no more than 2 prior lines of therapy for advanced disease and progressed or been intolerant to prior standard therapies (Arm C for Part 2 Dose Expansion).\n* Measurable disease per RECIST v1.1\n* Adequate organ function (bone marrow, liver, kidney, coagulation, endocrine).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Head and neck squamous cell carcinoma.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 4 weeks prior to receiving study drug(s).\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.\n* Other inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},370,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RAS(ON) inhibitors in combination with ivonescimab in adults with advanced or metastatic solid tumors with a RAS mutation.",[28,29,30,31,32,33],"Advanced Solid Tumors","Metastatic Solid Tumors","Non-small Cell Lung Cancer (NSCLC)","NSCLC","Colorectal Cancer (CRC)","CRC",[28,29,35,31,36,33,37,38,39,40,41],"Non-small Cell Lung Cancer","Colorectal Cancer","RAS","NRAS","KRAS","HRAS","RAS Mutation","RECRUITING","2026-06-26",{"date":45,"type":46},"2026-06-29","ACTUAL",{"date":48,"type":46},"2026-01-30",{"date":50,"type":21},"2029-05",{"name":52,"class":53},"Revolution Medicines, Inc.","INDUSTRY",6,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":72,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100642407","phase-1-phase-i-study-of-jfi447-68gaga-dfc413-and-comparison-to-ffg233-68gaga-nns309-in-patients-with-solid-tumors-100642407","NCT07630961","Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors","Phase I, Open Label First in Human Study to Evaluate the Imaging Characteristics, Safety, Biodistribution and Pharmacokinetics of JFI447 [68Ga]Ga-DFC413, and Compare to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors","Inclusion Criteria:\n\nPatients eligible for inclusion in this study must meet all of the following criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study.\n2. Age ≥ 18 years old.\n3. ECOG performance status ≤ 2.\n4. Patients with one of the following indications (regardless of lines of prior therapy):\n\n   Locally advanced unresectable or metastatic PDAC, NSCLC, HR+\u002FHER2- ductal or lobular BC, TNBC, CRC or STS.\n5. Patients must have at least one measurable lesion per RECIST v1.1 as measured by local Investigator (by conventional MRI or CT scan).\n6. Patients must have an available archival tumor sample at the screening visit. If multiple archival tumor samples are available, the most recent will be requested. Exceptions may be made after documented discussion with Novartis.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are not eligible for inclusion in this study:\n\n1. Out-of-range laboratory values defined as:\n\n   * Estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin (calculated using CKD-EPI 2021 formula, or measured based on 24-hour urine collection)\n   * Total bilirubin \\> 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \\> 3.0 x ULN) or direct bilirubin \\> 1.5 x ULN\n   * Alanine aminotransferase (ALT) \\> 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT \\> 5.0 x ULN\n   * Aspartate aminotransferase (AST) \\> 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if AST \\> 5.0 x ULN\n   * Absolute Neutrophil Count \\\u003C 1.0 x 109\u002FL\n   * Hemoglobin \\\u003C 9 g\u002FdL\n   * Platelet count \\\u003C 75 x 109\u002FL\n2. Unmanageable urinary tract obstruction or urinary incontinence. If ureteral obstruction can be managed with the placement of ureteral stents, this exclusion criterion does not apply.\n3. Known hypersensitivity to 68Ga-DFC413 or 68Ga-NNS309 or their excipients.\n4. Any serious uncontrolled infection (acute or chronic), such as, but not limited to, bacterial, viral or fungal infections, confirmed by clinical evidence, imaging, and\u002For relevant positive laboratory tests (e.g., blood cultures, PCR for DNA\u002FRNA). If a serious infection develops, it must resolve or be adequately controlled prior to 68Ga-DFC413 and\u002For 68Ga-NNS309 initiation.\n5. Surgery or major invasive procedure within 4 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n6. Radiation therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n7. Change in anticancer therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n8. Radiological contrast administration within 48 hours prior to 68Ga-DFC413 or 68Ga-NNS309 administration.\n9. Initiation or increasing doses of corticosteroids, TGF-β signaling inhibitors or immunomodulators within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n10. Known additional malignancy that is progressing or requires active treatment.\n11. Inability to complete the required investigational and standard imaging examinations due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time).\n12. Presence of CTCAE version 5.0 ≥ Grade 2 toxicity due to prior cancer therapy, except for neuropathy (inclusion of patients with neuropathy of ≤ Grade 2 is permitted) and alopecia.\n13. Any medical condition that would, in the Investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures (including radiation safety precautions), or interpretation of study results.\n14. Pregnant women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.\n15. Nursing (breast-feeding) women. Women who do not breast feed for 12 hours after 68Ga-DFC413 and\u002For 68Ga-NNS309 administration, but express and discard breast milk, are eligible.\n16. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they use highly effective methods of contraception (failure rate \\\u003C1% per year) for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309.\n\n    Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. hormonal profile confirming menopause and\u002For age-appropriate history of vasomotor symptoms).\n\n    Highly effective contraception methods include:\n    * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n    * Bilateral tubal ligation, female sterilization (have had bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking 68Ga-DFC413 or 68Ga-NNS309. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential.\n    * Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient.\n    * Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example, hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n\n    If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent (IC).\n17. Sexually active males unwilling to use a condom during intercourse for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309. A condom is required for all sexually active male patients to prevent them from fathering a child and\u002For to prevent delivery of study treatment via seminal fluid to their partner. In addition, male patients must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the IC.\n\nOther protocol-defined inclusion\u002Fexclusioncriteria may apply.",{"count":63,"type":21},66,[24],"The purpose of Part 1 of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics of \\[68Ga\\]Ga-DFC413, and in Part 2 compare to \\[68Ga\\]Ga-NNS309 in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+\u002FHER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC), colorectal cancer (CRC), and soft tissue sarcoma (STS). In Part 2 of this study (comparison of \\[68Ga\\]Ga-DFC413 and \\[68Ga\\]Ga-NNS309), not all indications might be explored.",[67,30,68,69,70,32,71],"Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)","HR+\u002FHER2- Ductal Breast Cancer (BC)","HR+\u002FHER2- Lobular Breast Cancer (BC)","Triple Negative Breast Cancer (TNBC)","Soft Tissue Sarcoma (STS)",[73,74,75,76,77,78,79,80],"metastatic pancreatic ductal adenocarcinoma (PDAC)","non-small cell lung cancer (NSCLC)","HR+\u002FHER2- ductal breast cancer (BC)","HR+\u002FHER2- lobular breast cancer (BC)","triple negative breast cancer (TNBC)","colorectal cancer (CRC)","soft tissue sarcoma (STS)","radioligand imaging","2026-06-25",{"date":43,"type":46},{"date":84,"type":46},"2026-06-23",{"date":86,"type":21},"2028-01-22",{"name":88,"class":53},"Novartis Pharmaceuticals",1,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":89},"100598019","artificial-intelligence-assisted-colonoscopy-in-the-detection-and-characterization-of-colorectal-lesions-100598019","NCT07066046","Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions","Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions: Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* All patients aged 18 years or older, with an elective indication for colonoscopy who sign the informed consent form agreeing to participate in the study.\n\nExclusion Criteria:\n\n* History of inflammatory bowel disease.\n* History of colorectal cancer.\n* Personal history of colorectal surgery.\n* Contraindication to endoscopic biopsies.\n* History of intestinal polyposis syndromes.\n* Urgent or emergency cases.\n* Presence of severe, decompensated comorbidities, or with a score of 3 or higher according to the American Society of Anesthesiologists (ASA) classification.\n* Incomplete colonoscopy that does not reach the cecum.\n* Insufficient or inadequate bowel preparation, with a score lower than 6 on the Boston Bowel Preparation Scale.\n* Patients who do not agree to participate in the study and do not sign the informed consent form (ICF).",true,{"count":99,"type":21},1000,[101],"NA","The study aims to evaluate the effectiveness of artificial intelligence-assisted colonoscopy in increasing adenoma detection rate and the accuracy in the characterization of colorectal lesions, compared to standard colonoscopy, in a randomized controlled clinical trial setting.",[32,104,105,36],"Adenomatous Polyposis","Colorectal Lesions",[107,108,109,110],"Adenoma","Artificial Intelligence","Colonoscopy","Colorectal lesions","2026-06-19",{"date":84,"type":46},{"date":114,"type":46},"2025-02-01",{"date":116,"type":21},"2026-12-01",{"name":118,"class":119},"Instituto do Cancer do Estado de São Paulo","OTHER",{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"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":129,"type":21},1314,[24],"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.",[133,134,135,136,137,30,32,138,139,140],"Renal Cell Carcinoma (RCC)","Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Urothelial Carcinoma (UC)","Solid Tumor","Hepatocellular Carcinoma (HCC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","Clear Cell Renal Cell Carcinoma (ccRCC)","Non-Clear Cell Renal Cell Carcinoma (nccRCC)","2026-06-17",{"date":143,"type":46},"2026-06-22",{"date":145,"type":46},"2021-12-14",{"date":147,"type":21},"2030-06-28",{"name":149,"class":53},"Exelixis",122,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":89},"100641290","phase-1-a-phase-1-and-2-study-of-vmd-102-in-hepatocellular-carcinoma-and-other-solid-tumors-100641290","NCT07636785","A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors","A Phase 1 and 2 First-in-human, Open-label, Multicenter Study to Assess the Safety, Tolerability and Preliminary Efficacy of VMD-102 in Participants With Hepatocellular Carcinoma and Other Advanced Solid Tumors","SPKTAHC","Inclusion Criteria:\n\n* Histological or cytological or radiological diagnosis of advanced (unresectable and\u002For metastatic) HCC, MUM, RCC, NSCLC and CRC that is not responsive to standard of care (SOC), had progressed following SOC, is intolerant to SOC, or for whom the SOC is not considered appropriate by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, or 1.\n* Has at least one measurable target lesion according to RECIST v1.1 \\[Response Evaluation Criteria In Solid Tumors\\], or mRECIST \\[modified RECIST\\] for unresectable HCC participants, and either (a). has not been previously treated with local therapy (e.g., radiation therapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy), or (b). if the target lesion was within the field of local therapy, the lesion has shown an increase in size of 25% or greater following local therapy.\n* Adequate organ function evidenced by:\n\nHematology\n\n* Hemoglobin ≥ 9 g\u002FdL (SI Units: 90 g\u002FL) (post-transfusion if transfusion-dependent)\n* Platelet count ≥ 60000\u002Fmm3 (60 x109\u002FL) without support(transfusion) within 7 days of testing\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3 (1.5x109\u002FL) Chemistry\n* Total bilirubin (TBIL) ≤ 2.0 x upper limit of normal (ULN). (For participants with Gilbert's syndrome, TBIL ≤3.0 x ULN provided that direct bilirubin DBIL) is \\\u003C30% of the TBIL)\n* Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) 1 ≤ 5 x U LN (participants with advanced HCC or liver metastases)\n* AST and\u002For ALT 1 ≤ 3 x ULN (participants without known liver disease or liver metastases)\n* Calculated creatinine clearance or 24h urine creatinine clearance ≥50 mL\u002Fmin using Cockroft-Gault formula.\n* Serum creatinine ≤ 1.5x ULN\n\nCoagulation (unless taking an anti-coagulant):\n\n* Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (except for participants receiving therapeutic anticoagulants)\n* International normalized ratio (INR) ≤ 1.5 unless the participant is receiving anticoagulant therapy as long as the participant is within therapeutic range of intended use of anticoagulants\n* Albumin ≥2.8g\u002Fd\u002FL.\n\n  * For HCC participants: the diagnosis must be made based on American Association for the Study of Liver Diseases (AASLD) Guidelines with confirmed advanced (unresectable) HCC staged by Barcelona Clinic Liver cancer criteria (BCLC). Cirrhosis will be staged by Child-Pugh score, and such a score ≤ 6 will be eligible for Phase 1 and ≤7 for Phase 2.\n  * Participants must either have available archival tumor tissue samples, or consent to fresh tumor tissue sampling prior to the first dose unless the biopsy is not safe or not feasible per investigator assessment and with medical monitor approval.\n  * Women of childbearing potential (WOCBP) must have a negative pregnancy test prior to enrolment and agree to use a highly effective and acceptable method of contraception from the time of informed consent (or screening) until 6 months after the last dose of investigational agent.\n  * Male participants who are sexually active with a female partner of childbearing potential must agree to use a condom with spermicide from first dose of investigational agent until 6 months after the last dose, and refrain from sperm donation during that period. Abstinence from heterosexual intercourse is an acceptable method only if the participant's usual lifestyle already includes abstinence.\n  * Participant has a life expectancy of ≥3 months.\n  * No history of liver transplantation.\n  * Ability to swallow and absorb an orally self-administered medication in tablet form.\n  * Have completed any prior chemotherapy, monoclonal antibody or immunotherapy (e.g., tumor vaccine, cytokine, or growth factor given to control the cancer) at least 4 weeks or 5 half-lives (whichever is shorter) before study drug administration. Exceptions to these prior therapy timeframes are possible, on a case by case basis, following discussion and mutual agreement between Investigator and Sponsor.\n  * Adverse effects related to prior anticancer therapies must have either returned to baseline or resolved to Grade 0 or 1. Some toxicities with higher grades such as alopecia, immunotherapy-induced hypothyroidism or adrenal insufficiency or panhypopituitarism requiring stable doses of hormone replacement therapy or rash from prior therapy may be permitted with medical monitor approval.\n\nExclusion Criteria:\n\n* Received anticancer therapy with radiation, immunotherapy, a biologic, surgery and\u002For tumor embolization within the past 2 weeks or 5 half-lives (whichever is longer).\n* Currently pregnant, nursing, or planning to become pregnant during the course of study.\n* The Fridericia Corrected QT (QTcF) interval ≥ 480 msec.\n* Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system (Section 14.8); or presence of clinically significant and uncontrolled cardiac disease, as assessed by the investigator. Such as but not limited to: symptomatic congestive heart failure, unstable angina, cardiac arrhythmia.\n* Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the participant's safety or interfere with assessment of the drug.\n* Psychological, familial, sociological, geographical or other concurrent conditions that would interfere with safety evaluation, limit the participant's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Participants with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.\n* Participants have multiple factors that affect their oral medication (such as inability to swallow and intestinal obstruction or resection).\n* Participants have long-term unhealed wounds or fractures.\n* Participants have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.\n* Any current medical conditions, including impairment of GI function or GI disease, which would alter the absorption, distribution, metabolism or excretion of VMD-102 including but not limited to:\n\n  * Severe uncontrolled nausea or vomiting.\n  * Severe uncontrolled diarrhea or ongoing active diarrhea requires medications (e.g. bile acid sequestrant, loperamide).\n  * A history of short bowel syndrome; irritable bowel syndrome with diarrheal signs\u002Fsymptoms or require medications.\n  * Clinically diagnosed malabsorption secondary to bowel resection.\n  * Active Ulcerative colitis or Crohn's disease requiring medication for control.\n  * Surgical procedures of the GI tract impacting the drug absorption such as but not limited to small bowel resection and gastric bypass.\n* Unstable central nervous system (CNS) metastases. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least one cycle prior to the first dose and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are on stable doses of steroids for at least one cycle prior to the first dose.\n* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC or HCC due to cirrhosis caused from autoimmune-associated hepatitis.\n* Hepatitis B surface antigen (HBsAg) positive with detectable the hepatitis B virus load (HBV DNA) \\>100 IU\u002FmL. Participants on active HBV therapy with viral loads \\\u003C100 IU\u002FmL should stay on the same therapy throughout study intervention and at least 12 weeks after the study is over. Participants cannot be actively co-infected with hepatitis C virus (HCV; HCV RNA detectable) or hepatitis delta virus (HDV; HDV RNA detectable).\n* Positive HBsAg, with or without detectable HBV DNA, if there is evidence in the medical history of an advanced stage of cirrhosis ( Child-Pugh B) or history of decompensated chronic liver disease\n* HCV antibody (HCVAb) positive and HCV viral load (HCV RNA) detectable. Previous HCVAb positive with HCV RNA undetectable due to treatment (DAAs or interferon) is allowed but the treated participants must have completed their treatment at least 12 weeks prior to starting study intervention and HCV RNA must be documented at below the limit of quantification.\n* History of allogeneic tissue\u002Forgan transplantation (including bone marrow, stem cell, liver, or kidney transplants), except those that do not require immunosuppressive therapy (e.g., corneal or hair transplants).\n* Coronavirus disease 2019 (COVID-19) or any live attenuated vaccine within 4 weeks of study entry.\n* Participants with active alcohol and\u002For substances abuse, Phosphatidylethanol (Peth) must be \\\u003C50 ng\u002FmL).\n* Concurrent secondary malignancy other than that being treated in this study. Exceptions to this exclusion include malignancies treated curatively and have not recurred within 2 years prior to study entry or tumors treated with curative intent that have expected cure rates of \\>90% such as but not limited to: basal cell and squamous skin cancer and completely resected carcinoma in situs.\n* Participants have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage. Exception may be possible, on a case by case basis, e.g. if no more than one paracentesis in a month and a drain is pre-placed for the participant to drain, following discussion and mutual agreement between Investigator and Sponsor\n* Participants have long-term unhealed wounds or fractures.\n* Participants receiving known potent P-glycoprotein (P-gp) efflux transporter inhibitors that cannot be discontinued 3 days prior to the start of study treatment and during the course of the Phase 1 study.\n* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drug, or excipients.\n* Known history of uncontrolled human immunodeficiency virus (HIV) infection.\n* Any other condition that, in the opinion of the Investigator or the medical monitor, could increase the risk to the participant, interfere with study participation, or affect the proper interpretation of study results and objectives. Such conditions may include but are not limited to, active infections, uncontrolled diabetes, psychiatric illness, social situations, and concomitant therapies.","75 Years",{"count":161,"type":21},111,[24,25],"This study is to evaluate the safety and tolerability to determine (i) the recommended Phase 2 dose (RP2D) of VMD-102 (Phase 1), and (ii) preliminary anti-tumor efficacy (Phase 2), in participants with advanced HCC, metastatic uveal melanoma (MUM), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). The pharmacokinetics (PK), preliminary anti-tumor activity, and potential biomarkers of VMD-102 will also be assessed.\n\nVMD-102 will be the first selective PKC epsilon (PKCε or PKCe) kinase inhibitor to enter human clinical testing. Preclinical VMD-102 anti-tumor activities in mouse liver\u002FHCC tumor models and preclinical toxicology and pharmacology studies support this study.",[137,165,133,166,32],"Metastatic Uveal Melanoma","Nonsmall Cell Lung Cancer","NOT_YET_RECRUITING","2026-06-16",{"date":170,"type":46},"2026-06-18",{"date":172,"type":21},"2026-06",{"date":174,"type":21},"2031-12",{"name":176,"class":53},"VM Discovery, Inc.",{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":159,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":89},"100643072","phase-2-a-phase-ii-study-of-pirfenidone-plus-pd-1-inhibitor-with-or-without-hypofractionated-radiotherapy-for-refractory-pmmrmss-colorectal-cancer-100643072","NCT07644286","A Phase II Study of Pirfenidone Plus PD-1 Inhibitor With or Without Hypofractionated Radiotherapy for Refractory pMMR\u002FMSS Colorectal Cancer","Phase II Study Evaluating the Safety, Tolerability, and Efficacy of Pirfenidone and PD-1 Inhibitor With or Without Hypofractionated Radiotherapy in Patients With Advanced, Refractory pMMR\u002FMSS Colorectal Cancer","Inclusion Criteria:\n\n1. Written informed consent must be provided, and the patient must be able to comply with the visit schedule and procedures outlined in the protocol.\n2. Age ≥ 18 years and ≤ 75 years, regardless of gender.\n3. Histologically or cytologically confirmed, unresectable locally advanced or metastatic pMMR\u002FMSS colorectal cancer.\n4. Patients must have progressed on standard therapy, be unsuitable for standard therapy due to intolerable toxicity, have no available standard therapy, or have refused standard therapy.\n5. Baseline\\* hematology tests (within 7 days prior to the first dose of study drug) must meet the following criteria:Hemoglobin ≥ 90 g\u002FL (without transfusion or erythropoietin support within 7 days prior to blood sampling).\n\nAbsolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL (without granulocyte colony-stimulating factor support within 7 days prior to blood sampling).Platelet count ≥ 100 × 10⁹\u002FL (without transfusion support within 7 days prior to blood sampling).Eosinophil count ≤ 1.5 × ULN.\n\n9.Throughout the protocol, \"baseline\" is defined as the last available observation prior to the first dose of the study drug. Patients must not have received any blood products or hematopoietic growth factor support within 7 days prior to the blood sample collection.\n\n10.Baseline serum biochemistry tests (within 7 days prior to the first dose) must meet the following criteria:Total bilirubin ≤ 1.5 × ULN (if total bilirubin is \\>1.5 × ULN, direct bilirubin must be ≤ ULN for inclusion).Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 × ULN.\n\nSerum creatinine ≤ 1.5 × ULN or Calculated Creatinine Clearance (CrCl) ≥ 45 mL\u002Fmin (using the Cockcroft-Gault formula and actual body weight).Albumin ≥ 30 g\u002FL.\n\n11.Baseline coagulation tests (within 7 days prior to the first dose) must meet the following criteria:International Normalized Ratio (INR) ≤ 1.5 × ULN (or ≤ 3 × ULN if on a stable dose of anticoagulant therapy).Partial Thromboplastin Time (PTT) or Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN (or ≤ 3 × ULN if on a stable dose of anticoagulant therapy).\n\n12.Baseline urinalysis (within 7 days prior to the first dose) must meet the following criterion: Urine Protein (UPRO) \\\u003C 2+ or 24-hour urinary protein quantification \\\u003C 1 g.\n\n13.At least one measurable lesion as defined by RECIST v1.1 criteria. 14.Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 15.Life expectancy ≥ 3 months. 16.Male patients with partners of reproductive potential and female patients of childbearing potential must agree to use highly effective contraception throughout the treatment period and for 6 months thereafter.\n\nExclusion Criteria:\n\n1. All colorectal cancer patients must have confirmed MSS\u002FpMMR status; patients with MSI-H\u002FdMMR are excluded.\n2. History of hypersensitivity to any study drug components, including PD-1 inhibitors and pirfenidone.\n3. Female patients who are pregnant, lactating, or planning to become pregnant within 6 months after the last dose of the study drug.\n4. Known history or presence of active seizure disorder, active central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. Patients with newly identified brain or leptomeningeal metastases are excluded.\n5. Significant cardiovascular or cerebrovascular diseases with clinical importance.\n6. History of allergic predisposition, asthma, or atopic dermatitis.\n7. Patients with massive pleural effusion or massive ascites.\n8. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within the past 2 years prior to the first dose. Replacement therapy is not considered systemic treatment.\n9. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n10. Known or suspected hypersensitivity to the study drugs or any of their excipients.\n11. History of significant toxicity related to prior immune checkpoint inhibitor therapy or pirfenidone treatment that led to permanent discontinuation of the drug.\n12. Presence of unresolved \\> Grade 1 toxicities (except for persistent Grade 2 alopecia, peripheral neuropathy, decreased hemoglobin, or hypomagnesemia) from any prior anticancer therapy.\n13. Active uncontrolled bleeding, known bleeding tendency, severe non-healing wounds, ulcers, fractures, or conditions such as esophageal\u002Fgastric varices requiring immediate intervention, or portal hypertension with high bleeding risk per investigator's assessment.\n14. History of intestinal obstruction (except if surgically cured or fully resolved) or risk of gastrointestinal perforation within 28 days prior to the first study dose.\n15. Current or recent (within 6 months) significant gastrointestinal disorders, including:\n\n    1. History of clinically significant GI bleeding,\n    2. Active peptic ulcer disease,\n    3. ≥ Grade 2 diarrhea within 2 weeks prior to the first study dose.\n16. Gastrointestinal diseases or prior surgeries that may affect the absorption of oral pirfenidone; uncontrolled tumor-related pain or symptomatic hypercalcemia.\n17. Known positive HIV status, active Hepatitis B, Hepatitis C, tuberculosis, or history of such infections. Exceptions include:\n\n    * Patients positive for HBsAg or HBcAb with HBV DNA ≤ 2.5×10³ copies\u002FmL or ≤ 500 IU\u002FmL or below the detection limit.\n    * Patients with positive HCV serology but undetectable HCV RNA.\n    * Patients who have received HCV treatment with undetectable viral load.\n18. Severe\u002Factive\u002Funcontrolled infection, infection requiring IV antibiotics, or unexplained fever (\\>38°C) within 2 weeks prior to the first study dose.\n19. Diagnosis of another malignancy within 5 years prior to the first dose, with exceptions for adequately treated basal cell carcinoma, squamous cell carcinoma, carcinoma in situ, or localized prostate\u002Fthyroid cancer treated with curative intent.\n20. Prohibited treatments prior to enrollment:\n\n    * Chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives (whichever is shorter) before the first study dose, with unresolved delayed toxicity.\n    * Monoclonal antibody therapy within 4 weeks prior to the first study dose.\n    * Participation in any interventional clinical trial involving medical devices or other therapies within 2 weeks prior to the first study dose.\n    * Palliative radiotherapy within 2 weeks prior to the first study dose.\n    * Live vaccines for infectious disease prevention within 4 weeks prior to the first study dose.\n    * Immunosuppressive or systemic steroid therapy (\\>10 mg\u002Fday prednisone equivalent) within 2 weeks prior to the first study dose.\n    * Unstable anticoagulation control, thrombotic events, pulmonary embolism, or clinically significant bleeding within 6 months.\n    * Major surgery within 4 weeks prior to the first study dose.\n21. Any condition, therapy, laboratory abnormality, history of substance abuse, or current situation that may compromise patient safety, interfere with informed consent, affect compliance, or confound safety assessment of the study drug per investigator's judgment.\n22. Patients deemed unsuitable for clinical trial participation by the investigator.",{"count":185,"type":21},48,[25],"This study aims to evaluate the safety, tolerability, and efficacy of pirfenidone and PD-1 monoclonal antibody combined with or without hypofractionated radiotherapy in the treatment of advanced refractory pMMR\u002FMSS colorectal cancer patients.",[32],"2026-06-11",{"date":191,"type":46},"2026-06-12",{"date":193,"type":46},"2025-12-01",{"date":195,"type":21},"2027-12-25",{"name":197,"class":119},"Tao Zhang",{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":213,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":231},"100593833","phase-2-a-study-of-fruquintinib-plus-folfiri-as-second-line-treatment-for-participants-with-metastatic-colorectal-cancer-fruitful-100593833","NCT07011576","A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)","A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)","FRUITFUL","Key Inclusion Criteria:\n\n* Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.\n* Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600\n* Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX\u002FBEV regimes are not permitted. A minimum of 2 cycles of first line of therapy must have been completed.\n* At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2\n\nKey Exclusion Criteria:\n\n* Current treatment with other anticancer treatments within 21 days of the first dose of study treatment\n* Major surgery within 4 weeks of the first planned dose of study treatment\n* More than one prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy.\n* Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure.\n* Uncontrolled, symptomatic brain metastases\n* Uncontrolled, symptomatic gastrointestinal disease\n* Participants with uncontrolled hypertension\n* Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 6 months after the last administration of study chemotherapy\n* Men who plan to father a child while in the study and for at least 6 months after the last administration of study chemotherapy\n* Documented major electrocardiogram (ECG) abnormalities which are clinically significant.\n* Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment\n* Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening",{"count":207,"type":21},60,[25],"This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to:\n\n* Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting\n* Evaluate the safety of the combination of fruquintinib + FOLFIRI",[211,212,36,32],"Colon Cancer","Rectal Cancer",[214,211,215,216,217,218,219,220,221,222],"Colorectal cancer","Rectal cancer","Metastatic colorectal cancer","mCRC","VEGFR inhibitor","Fruquintinib","FOLFIRI","Second line","2L mCRC","2026-06-10",{"date":191,"type":46},{"date":226,"type":46},"2025-09-29",{"date":228,"type":21},"2027-06",{"name":230,"class":119},"SCRI Development Innovations, LLC",14,{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":247,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":264},"100617629","phase-1-a-study-to-investigate-the-safety-tolerability-pharmacokinetics-and-anti-tumor-activity-of-cbi-1214-t-cell-engager-in-participants-with-advanced-or-metastatic-mssmsi-l-colorectal-cancer-100617629","NCT07321106","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS\u002FMSI-L Colorectal Cancer","A Phase 1, First-in-human (FIH), Dose-Escalation and Dose-Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic Microsatellite Stable (MSS)\u002FMicrosatellite Instability Low (MSI-L) Colorectal Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Participant with MSS\u002FMSI-L CRC, who has exhausted at least one prior line of standard systemic therapy for their current malignancy.\n* Participant with genomic aberrations, including but not limited to BRAFV600E mutations and HER2 amplifications, for which FDA-approved targeted therapies are available, must:\n\n  * Have received prior treatment with applicable FDA-approved targeted therapies AND\n  * Either have experienced disease progression, be refractory, or be intolerant to directed molecular therapy.\n* Participant able to provide archival tissue sample or fresh biopsy tissue sample\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Participant whose CRC tumor tissues have been identified as dMMR or MSI-H\n* Known history of solid organ or tissue transplant; history of interstitial lung disease or non-infectious pneumonitis.\n* Untreated central nervous system (CNS) metastatic disease.\n* Active autoimmune disease that has required systemic treatment within the past 2 years (participants with hormone replacement therapy for adequately controlled endocrinopathy are allowed in the study).\n* History of recent infection (within 4 weeks of C1D1) considered to be caused by one of the pathogens: HSV1, HSV2, VZV, EBV, CMV, measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D68.\n* Known seropositive for human immunodeficiency virus, hepatitis B surface antigen, or antibody to hepatitis C virus with confirmatory testing and requiring anti-viral therapy.\n* History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.\n* Significant medical comorbidities, including uncontrolled hypertension (diastolic blood pressure \\>115 mm Hg), unstable angina, congestive heart failure (greater than New York Heart Association class II), severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia, poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty, or myocardial infarction within 6 months prior to screening, or uncontrolled atrial or ventricular cardiac arrhythmias.\n* Congenital long QT syndrome or a corrected QT interval (QTc) ≥480 ms at screening (unless secondary to pacemaker or bundle branch block).\n* Active second primary malignancy within 3 years of Screening other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, or ductal or lobular carcinoma in situ of the breast",{"count":240,"type":21},80,[24],"This study will investigate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214 in participants with advanced or metastatic Microsatellite Stable (MSS)\u002FMicrosatellite Instability Low (MSI-L) Colorectal Cancer",[36,32,244,33,245,211,246],"Colorectal (Colon or Rectal) Cancer","Metastatic Colon Cancer","Advanced Colorectal Cancer",[248,136,249,250,251,252,253,254,255],"Oncology","Phase 1","First-in-Human","Dose Escalation","Open-Label","T-Cell Engager","TCE","CartographyBio","2026-06-09",{"date":223,"type":46},{"date":259,"type":46},"2026-01-15",{"date":261,"type":21},"2029-10",{"name":263,"class":53},"Cartography Biosciences",8,{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":298},"100576736","phase-1-a-phase-1-first-in-human-study-of-okn4395-and-pembrolizumab-in-patients-with-solid-tumors-100576736","NCT06789172","A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors","A Phase 1, Open-label, Multicenter, Dose-escalation and Cohort Expansion Study of OKN4395, a Triple Antagonist of EP2, EP4, and DP1 Prostanoid Receptors, as Monotherapy and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors","INVOKE","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed disease, locally advanced or metastatic:\n\n   For Phase 1a:\n\n   Solid tumor with a COX2-associated immunosuppressive pathway, for which standard treatment options are not available, no longer effective, refused or not tolerated.\n\n   For Phase 1b:\n\n   For all cohorts, in the opinion of the investigator, all appropriate authorized treatment options should be exhausted\n   * Cohort 1: Sarcoma (fibrous sarcoma \\[myxofibrosarcoma or solitary fibrous tumor\\], dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma or pleomorphic sarcoma, or leiomyosarcoma), that is either refractory to or progressing on standard of care, with no more than 3 prior lines of systemic therapy. Patients with a solitary fibrous tumor can be included in the study without prior treatment if, in the investigator's opinion, it is in the participant's best interest and no established standard of care exists or is available.\n   * Cohort 2: NSCLC (squamous or adenomatous without EGFR\u002FALK mutations), with disease progression on a PD-(L)1 CPI regimen, and no more than 3 prior lines of systemic therapy. When known, PD-L1 status should be provided.\n   * Cohort 3: CRC (Microsatellite stable or Microsatellite instability - low), and no more than 4 prior lines of systemic therapy.\n   * Cohort 4: GC (gastric and gastro-esophageal junction adenocarcinoma), HER2-negative, planned to or currently receiving CPI monotherapy as maintenance of a first-line CPI + chemotherapy regimen, after chemotherapy cessation.\n2. ECOG performance status of 0 or 1.\n3. Recovery from any medically relevant AE\u002FirAE from previous treatment regimen (defined as recovery to Grade ≤1 level per CTCAE v 5.0 before Screening, or chronic, stable, Grade 2 AEs \\[not worsened to Grade \\>2 for \\>3 months prior to screening\\]).\n4. One or more new or growing tumor lesions amenable to a safe biopsy (at baseline, a suitable archival specimen obtained when not undergoing treatment and within 1 year \\[Phase 1a\\], or within 90 days and after the last administration of the previous systemic therapy \\[Phase 1b\\] is suitable). In addition (where applicable) an archival tumor biopsy collected before the start of the first-line treatment in the metastatic setting is requested (but optional).\n5. At least one target lesion measurable by RECIST 1.1 as noted by local investigators\u002Fradiologists.\n6. The ability to swallow and retain OKN4395 as an oral medication without significant gastrointestinal abnormalities that might alter absorption.\n7. The willingness and ability to comply with the evaluation, randomizations and requirements of the protocol. For Substudy 1, the ability to comply with the evaluation requirements includes the absence of any condition known to affect upper gastrointestinal motility, absorption, and pH.\n8. Adequate hematologic, renal, and hepatic function (based on local laboratory assessments):\n\n   1. Hematological variables: absolute neutrophil counts ≥1.5 × 109 \u002FL, platelet counts ≥75 × 109 \u002FL, and hemoglobin ≥8 g\u002FdL\n   2. Renal variables: creatinine clearance ≥ 60 mL\u002Fmin1 by Du Bois \\& Du Bois formula\n   3. Hepatic variables: total serum bilirubin ≤1.5 × ULN, AST and ALT ≤3 × ULN, and ALP ≤2.5 × ULN; except for hyperbilirubinemia of Gilbert's syndrome (participants with Gilbert's syndrome can be included if total serum bilirubin ≤5× ULN and direct bilirubin ≤1.5 x ULN)\n   4. Serum albumin ≥30 g\u002FL\n\nExclusion Criteria:\n\n1. Except for the current regimen in Cohort 4, ongoing or recent anticancer therapy within the following timeframe prior to first dose of study drug:\n\n   1. Chemotherapy, ADCs, or other antibodies \\\u003C 21 days\n   2. Immunotherapy or cellular therapy \\\u003C 28 days\n   3. Radiation therapy (palliative radiation for bone pain \\\u003C48 hours; stereotactic or small field brain irradiation \\\u003C7 days; all other radiation therapy \\\u003C14 days)\n   4. TKI or any other anticancer therapy \\\u003C 5 half-lives or \\\u003C 7 days, whichever is longer\n2. Central nervous system metastasis (radiologically progressive, or clinically symptomatic, or requiring immunosuppressive therapies \\[including low dose steroids\\]).\n3. Any active infection (bacterial, viral, fungal) requiring IV systemic therapy.\n4. Unstable COPD defined as frequent or severe exacerbations per investigator discretion.\n5. Known history of or active HBV (HBsAg reactive and\u002For HBV DNA detected) or HCV (HCV RNA detected) infection.\n6. HIV infection with CD4 lymphocyte count \\\u003C350 cells\u002FμL at time of Screening, or failure to achieve and maintain virologic suppression defined as confirmed HIV RNA level \\\u003C 50 or lower limit of detection by the local available assay at time of Screening and for at least 12 weeks prior to Screening.\n7. Known history of bleeding disorders, INR ≥1.5 × ULN at screening (or INR and\u002For aPTT within therapeutic range if on anticoagulation therapy), or a history of gastrointestinal bleeding (inflammatory, ulcerative, or diverticular) within the last 2 years.\n8. Known H. pylori infection without proof of eradication at least 2 months prior to screening.\n9. Systemic treatment with any drug known to impact gastrointestinal pH within 7 days (PPIs) or 12 hours (H2 antagonists) of first dose of OKN4395 (unless adapted after Substudy 1). Where said treatments have been used for more than 2 weeks prior to discontinuation, discontinuation should occur at least 21 days before first dose of OKN4395.\n10. Acute treatment with any systemic steroid therapy (\\>10 mg prednisone equivalent), or any corticosteroid medication within 14 days of first dose of OKN4395 for any condition.\n11. For participants planned to receive combination therapy: Ongoing and history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Any replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. Participants with hyperthyroidism or hypothyroidism but that are stable on hormone replacement are also allowed.\n12. Systemic treatment with NSAIDs, COX2 inhibitors, or synthetic prostaglandins within 5 half-lives prior to the first dose of OKN4395 (acetylsalicylic acid ≤ 160 mg\u002Fday, or 325 mg ≤ 3 times\u002Fweek is permitted).\n13. Systemic treatment with strong inhibitors\u002Finducers of CYP and UGT enzymes within 14 days of first dose of OKN4395.\n14. QTcF interval of \\> 450 ms based on mean of the central triplicate readings.\n15. Known hypersensitivity to any excipients of the OKN4395 formulation or pembrolizumab (for combination cohorts).\n16. Pregnant or lactating women. Women of childbearing potential must have a negative serum pregnancy test at screening and have a negative a urine dipstick pregnancy test prior to the initiation of study treatment (can be done on C1-D1 visit).\n17. Evidence of any other active malignancy requiring systemic therapy within the 2 years prior to Screening. (Exceptions: non-melanoma skin cancer, in situ melanoma, in situ cervical cancer, ductal carcinoma in situ of the breast, or localized and presumed cured prostate cancer; participants on long-term anti-hormonal therapy for a prior malignancy are allowed if the malignancy has not been active within the prior 2 years).\n18. History or current evidence of any condition, surgical or medical therapy, or laboratory abnormalities that might confound the results of the study, make study drug administration hazardous, interfere with the participant's involvement for the full duration of the study, or make it difficult to monitor AEs such that, in the opinion of the treating physician, it is not in the best interest of the participant to participate",{"count":274,"type":21},146,[24],"The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab.\n\nThe overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab.\n\nThis study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395 either alone (monotherapy) or with pembrolizumab (combination therapy) administered on day 1 of each 21-day cycle in patients with solid tumors until the participant has disease progression or discontinues for any reason. The dose of OKN4395 will be increased, after each group of 3 or more participants completes their first 3 weeks of treatment and their data is evaluated for safety, with a planned dose range from 10 mg twice a day to 450 mg twice a day through 13 dose levels. Part 1a also includes a parallel substudy (Substudy 1) consisting of at least 12 participants, aiming to test the effect of food and stomach acid on the levels of OKN4395 in the blood as well as its tolerability.\n\nPart 1b will evaluate OKN4395 alone and in combination with pembrolizumab administered on day 1 of each 21-day cycle in patients with selected cancer types. Part 1b will comprise 4 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 in non-small cell lung cancer (NSCLC), Cohort 3 in colorectal cancer, and Cohort 4 in gastric cancer (GC), with cohorts 2 to 4 in combination with pembrolizumab.\n\nThe overall study will enrol approximately 146 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 80 participants in Part 1b split: 20 on monotherapy and 60 on combination therapy.\n\nThe study will be conducted in the US, Australia, UK and in the EU.",[278,279,280,281,31,32,282,283,284,285,286,287,288,289,290],"Solid Tumours","Sarcoma","HNSCC","Non Small Cell Lung Cancer","Myxofibrosarcoma (MFS)","Solitary Fibrous Tumors","Dedifferentiated Liposarcoma","Undifferentiated Pleomorphic Sarcoma (UPS)","Leiomyosarcoma","Leiomyosarcoma (LMS)","Gastric Cancer (GC)","Gastric Cancer Adenocarcinoma Metastatic","Gastric \u002F Gastroesophageal Junction Adenocarcinoma",{"date":189,"type":46},{"date":293,"type":46},"2025-01-23",{"date":295,"type":21},"2028-09",{"name":297,"class":53},"Epkin",10,{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":305,"enrollmentInfo":306,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":4},"100583944","phase-1-efficacy-and-safety-of-trifluridinetipiracil-tas-102-combined-with-bevacizumab-and-serplulimab-in-patients-with-metastatic-colorectal-cancer-undergoing-cytoreductive-surgery-a-single-arm-single-center-clinical-study-100583944","NCT06882915","Efficacy and Safety of Trifluridine\u002FTipiracil (TAS-102) Combined With Bevacizumab and Serplulimab in Patients With Metastatic Colorectal Cancer Undergoing Cytoreductive Surgery: A Single-Arm, Single-Center Clinical Study","Inclusion Criteria:\n\n1. Patients who had undergone cytoreductive surgery (CC0-1) for colorectal cancer with peritoneal metastases;\n2. Patients with extra-peritoneal metastatic lesions that were unlikely to affect prognosis in the short term;\n3. Patients who had failed standard therapies (disease progression or intolerance to oxaliplatin, irinotecan, fluorouracil, or other chemotherapeutic agents) or for whom no effective treatment options were available;\n4. Patients with histologically and radiologically confirmed peritoneal metastasis from colorectal cancer, with microsatellite stable (MSS) status as determined by genetic testing;\n5. Age ≥ 18 years at the time of informed consent;\n6. Estimated life expectancy \\> 6 months;\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n8. Adequate function of major organs (cardiac, hepatic, and renal);\n9. Adequate hematological parameters: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, white blood cell count (WBC) ≥ 3.0 × 10⁹\u002FL, hemoglobin ≥ 10 g\u002FdL, and platelet count ≥ 100 × 10⁹\u002FL;\n10. Adequate biochemical parameters: total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; serum creatinine and blood urea nitrogen (BUN) ≤ 1.5 × ULN;\n11. Ability to comply with the study protocol and follow-up procedures.\n\nExclusion Criteria:\n\n1. Refusal to provide informed consent;\n2. Currently participating in an interventional clinical study, or having received other investigational drugs or devices within 4 weeks prior to enrollment;\n3. Concurrent malignancy, except for malignancies that have been clinically cured;\n4. Other severe diseases that, in the investigator's judgment, may affect follow-up compliance or short-term survival;\n5. Known hypersensitivity to any component of TAS-102, bevacizumab, or serplulimab;\n6. Uncontrolled brain metastases;\n7. Active autoimmune disease;\n8. Pregnant or lactating women;\n9. History of psychiatric disorders;\n10. Uncontrolled comorbidities including, but not limited to, active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, severe coronary artery disease, or cerebrovascular disease, or any other condition deemed by the investigator to render the patient ineligible for enrollment;\n11. Any other condition that the investigator considers unsuitable for enrollment.","80 Years",{"count":307,"type":21},20,[24],"Colorectal cancer (CRC) is one of the most common malignant tumors. With the rapid development of China's economy, people's living standards have been significantly improved, and lifestyles and dietary structures have changed. Smoking, drinking, high-fat, high-energy diets, etc. have led to an increase in the incidence of colorectal cancer year by year. Data show that in 2022, there will be 510,000 new cases of colorectal cancer in China, and about 240,000 deaths related to colorectal cancer. Radical surgery is the main initial treatment for early and middle-stage colorectal cancer and some metastatic colorectal cancer. Although the level of surgical treatment of colorectal cancer has been greatly improved and can achieve cure for some patients, its 5-year overall survival rate is only about 60%, and the main cause of death is distant metastasis and recurrence. In recent years, with the in-depth understanding of the treatment mechanism of metastatic colorectal cancer (mCRC), a variety of new treatment options have been proposed and applied in clinical practice in order to improve the quality of life of patients and prolong their survival.\n\nTrifluridine\u002Ftipivirine (TAS-102) is a new type of cytotoxic drug that exerts anti-tumor effects by directly incorporating into DNA chains to destroy DNA function. Its mechanism of action is different from that of fluorouracil drugs, and it can resist 5-fluorouracil (5-FU) resistance, providing a new treatment option for mCRC patients. TAS-102 has been approved in China for mCRC patients who have previously received fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, as well as those who have previously received or are not suitable for anti-vascular endothelial growth factor (VEGF) therapy and anti-epidermal growth factor receptor (EGFR) therapy (RAS wild type). Bevacizumab, as a monoclonal antibody targeting VEGF, exerts its anti-tumor effect by inhibiting tumor angiogenesis. Putlimumab, as an immune checkpoint inhibitor, enhances the body's immune response to tumors by blocking the PD-1\u002FPD-L1 signaling pathway.\n\nCombination therapy has attracted much attention due to its possible synergistic effect. Studies have shown that TAS-102 combined with bevacizumab can achieve longer overall survival (OS) than TAS-102 monotherapy. In addition, TAS-102 combined with bevacizumab for refractory mCRC has also been approved by the FDA, showing its potential and importance in the treatment of mCRC. Therefore, this study aims to explore the efficacy and safety of TAS-102 combined with bevacizumab and putelimab in patients with mCRC after cytoreductive surgery, in order to provide a more effective treatment for mCRC patients. Through the design of a single-arm, single-center clinical study, we can have a deeper understanding of the efficacy and safety of this combined treatment in a specific patient population, providing a scientific basis for future clinical applications.",[32],"2026-06-04",{"date":313,"type":46},"2026-06-08",{"date":315,"type":21},"2026-06-06",{"date":317,"type":21},"2027-05-01",{"name":319,"class":119},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":331,"conditions":332,"keywords":338,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":352},"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":329,"type":21},300,[24],"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.",[333,334,32,335,139,336,337],"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)",[40,39,38,339,340,249,341,31,342,343,344,33],"Farnesyltransferase inhibitor (FTI)","Tyrosine Kinase inhibitor (TKI)","KRAS G12C inhibitor","ccRCC","RCC","PDAC",{"date":313,"type":46},{"date":347,"type":46},"2023-10-18",{"date":349,"type":21},"2027-04",{"name":351,"class":53},"Kura Oncology, Inc.",38,{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":364,"conditions":365,"keywords":366,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":379,"locationsCount":381},"100639855","ai-integrated-emotional-granularity-training-for-resilience-and-quality-of-life-in-colorectal-cancer-survivors-100639855","NCT07611071","AI-Integrated Emotional Granularity Training for Resilience and Quality of Life in Colorectal Cancer Survivors","Development and Evaluation of an AI-Integrated Emotional Granularity Growth (AI-EGG) on Enhancing Resilience and Improving Quality of Life in Young and Middle-Aged Colorectal Cancer Survivors","Inclusion Criteria:\n\n* (1) young and middle-aged adult patients (age in the range of 18-60 years);\n* (2) patients diagnosed with CRC;\n* (3) patients have completed primary curative-intent treatment for colorectal cancer, and are currently in a stable post-treatment or maintenance phase of care without evidence of active disease progression or acute treatment-related instability;\n* (4) patients able to use a smartphone and agree to participate in the study.\n\nExclusion Criteria:\n\n* (1) patients who have been informed of their cancer diagnosis due to family decision to withhold information;\n* (2) patients suffering from severe comorbidities or conditions that may affect participation or assessment, such as significant cognitive impairment (e.g., dementia, severe memory loss), psychiatric disorders, or other serious medical complications;\n* (3) those who are participating in other psychological intervention studies.","60 Years",{"count":362,"type":21},54,[101],"The goal of this clinical trial is to evaluate an AI-integrated Emotional Granularity Growth intervention (AI-EGG) designed to enhance resilience and improve quality of life in young and middle-aged colorectal cancer (CRC) survivors. Emotional granularity refers to the ability to clearly identify and differentiate subtle emotional experiences, which may help individuals regulate emotions more effectively and build resilience after cancer treatment.\n\nThe main questions it aims to answer are:\n\n* Does the AI-EGG intervention improve resilience in CRC survivors compared with routine psychological care?\n* Does the intervention improve emotional granularity, emotion regulation ability, and quality of life?\n* Is the AI-EGG intervention feasible and acceptable for young and middle-aged CRC survivors?\n\nResearchers will compare the AI-EGG intervention group to a control group receiving routine psychological care and standard educational materials to see whether the intervention leads to better psychological outcomes.\n\nParticipants will:\n\n* Complete baseline assessments measuring emotional granularity, emotion regulation, resilience, and quality of life\n* Be randomly assigned to either the intervention group or the control group\n* In the intervention group, engage in a 4-week AI chatbot-based program focusing on emotional identification, differentiation, regulation, and reflective practice (at least two sessions per week)\n* In the control group, receive routine psychological care and standard educational materials\n* Complete post-intervention assessments immediately after the 4-week program and again at a 1-month follow-up\n* Some participants in the intervention group will be invited to complete interviews about their experience of the program",[32],[367,368,369,370,371,372,373],"Emotional Granularity","Psychological Resilience","Young and Middle-Aged Adults","Colorectal Neoplasms","Emotional Regulation","Quality of Life","Randomized Controlled Trial","2026-06-03",{"date":311,"type":46},{"date":377,"type":21},"2026-06-01",{"date":116,"type":21},{"name":380,"class":119},"The Hong Kong Polytechnic University",3,{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":394,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":410},"100519207","phase-1-study-of-rmc-9805-in-participants-with-kras-g12d-mutant-solid-tumors-100519207","NCT06040541","Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors","Phase 1\u002F1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant Solid Tumors","Inclusion Criteria:\n\n* Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation\n* Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage\n* ECOG performance status 0 or 1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Primary central nervous system (CNS) tumors\n* Known or suspected leptomeningeal or active brain metastases or spinal cord compression\n* Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication\n* Participant was previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":390,"type":21},604,[24],"This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.",[30,32,335,28],[395,31,33,344,35,396,36,211,397,398,399,400,370,401,39,402],"KRAS G12D (ON)","Lung Cancer","Pancreatic Cancer","Metastatic Cancer","Pancreatic Ductal Adenocarcinoma","Pancreatic Neoplasms","Gastrointestinal Neoplasms","Colonic Neoplasms","2026-06-02",{"date":374,"type":46},{"date":406,"type":46},"2023-09-07",{"date":408,"type":21},"2027-04-30",{"name":52,"class":53},17,{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":22,"phases":420,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":89},"100637602","phase-1-study-of-lt-010391-in-participants-with-kras-g12d-mutant-solid-tumors-100637602","NCT07624214","Study of LT-010391 in Participants With KRAS G12D-Mutant Solid Tumors","A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-010391 Tablets in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation","Inclusion Criteria:\n\n* Participants with histologically or cytologically confirmed advanced solid tumors harboring a KRAS G12D mutation;\n* Failed standard therapy, intolerant to standard therapy, or no standard therapy is available;\n* ECOG Performance Status of 0 or 1;\n* Adequate organ function\n\nExclusion Criteria:\n\n* History of ≥2 primary malignancies within 5 years prior to signing informed consent, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or other malignancies considered cured;\n* Primary central nervous system (CNS) tumors\n* leptomeningeal metastases, brainstem metastases, or spinal cord compression confirmed by imaging (regardless of symptoms) Other inclusion\u002Fexclusion criteria may apply.",{"count":419,"type":21},198,[24],"This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors",[30,32,335,28],"2026-05-31",{"date":374,"type":46},{"date":426,"type":21},"2026-07",{"date":428,"type":21},"2029-04",{"name":430,"class":53},"Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.",{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":445,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":453},"100619816","phase-1-study-of-rmc-5127-in-patients-with-advanced-kras-g12v-mutant-solid-tumors-100619816","NCT07349537","Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors","Phase 1\u002F1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy.\n* Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage.\n* Measurable per RECIST v1.1\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Primary central nervous system (CNS) tumors\n* Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and\u002For inhibitors).\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to receiving study drug(s).\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.",{"count":439,"type":21},574,[24],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.",[30,32,443,335,344,33,31,397,444,28],"Pancreatic Adenocarcinoma","Lung Cancer (NSCLC)",[28,397,399,344,36,33,396,35,31,37,39,41],"2026-05-28",{"date":377,"type":46},{"date":449,"type":46},"2026-01-08",{"date":451,"type":21},"2028-10",{"name":52,"class":53},5,{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":22,"phases":463,"briefSummary":464,"conditions":465,"keywords":467,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":264},"100610089","phase-1-a-study-to-evaluate-the-safety-tolerability-and-efficacy-of-bms-986523-alone-and-in-combination-with-anti-cancer-agents-in-participants-with-advanced-solid-malignancies-100610089","NCT07223047","A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies","A Phase 1\u002F2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies","Inclusion Criteria\n\n* Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification).\n* Participants must, for Arm D, have a PD-L1 expression (≥50%).\n* Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments.\n\nExclusion Criteria\n\n* Participants must not have untreated central nervous system (CNS) metastases.\n* Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.\n* Participants must not have a history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis. A history of radiation pneumonitis in the radiation field is permitted.\n* Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":462,"type":21},252,[24,25],"The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies",[466,30,32,335],"Advanced Solid Malignancies",[30,32,335,397,396,468],"Kirsten rat sarcoma viral oncogene homolog (KRAS)","2026-05-26",{"date":446,"type":46},{"date":472,"type":46},"2025-11-25",{"date":474,"type":21},"2028-10-13",{"name":476,"class":53},"Bristol-Myers Squibb",{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":17,"minAge":484,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":494,"leadSponsor":496,"locationsCount":89},"100637158","transcutaneous-electrical-acustimulation-on-postoperative-bowel-function-recovery-in-elderly-patients-100637158","NCT07574502","Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients","Efficacy of Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients With Colorectal Cancer: A Multicenter Randomized Controlled Trial Study Protocol","Inclusion Criteria:\n\n* Age ≥ 65 years old.\n* Elective minimally invasive (laparoscopic or robotic) resection of colorectal cancer.\n* American Society of Anesthesiologists classification (ASA) 1-4.\n* Able to understand the research process and the use of various assessment scales, and able to communicate effectively with the researchers.\n* The patient voluntarily participates in this study and signs the informed consent form.\n\nExclusion Criteria:\n\n* Previous history of abdominal gastrointestinal surgery.\n* Planned for palliative or emergency surgery.\n* Planned for open abdominal surgery or creation of a new stoma.\n* Transfer to ICU.\n* Diagnosed with severe heart, liver, kidney or mental system diseases.\n* Patients with implanted cardiac pacemakers.\n* Patients currently using or having used in the past month glucagon-like peptide-1 (GLP-1) receptor agonists, dual glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, and sodium-glucose cotransporter-2 (SGLT-2) inhibitors.\n* Planned to use epidural anesthesia or epidural analgesia.\n* Presence of local skin lesions, infection at the stimulation site, or obvious skin allergy or severe skin sensitivity to electrodes\u002Fadhesive materials.\n* Participated in other clinical studies within the past 3 months or received acupuncture treatment within the past month.\n* Other conditions that the investigator considers make the patient unsuitable for participation in this study.","65 Years",{"count":486,"type":21},190,[101],"The goal of this clinical trial is to clarify the efficacy and safety of transcutaneous electrical acustimulation (TEA) in elderly patients with colorectal cancer, and to evaluate its clinical value in promoting postoperative intestinal function recovery and reducing the incidence of intestinal complications. The main questions it aims to answer are:\n\nCan TEA promote the recovery of intestinal function in elderly patients with colon cancer after surgery? What medical problems might occur to the participants when using TEA? The researchers will compare TEA with the control group (non-acupoint sham stimulation) to see if TEA is effective in promoting the recovery of intestinal function after surgery.\n\nParticipants will:\n\nStarting from the first day after the surgery, they received TEA or sham stimulation twice a day for a total of 3 days.\n\nRecord the time of the first defecation, defecation, and eating. Record their symptoms and adverse events.",[32],"2026-05-14",{"date":492,"type":46},"2026-05-15",{"date":377,"type":21},{"date":495,"type":21},"2028-12-31",{"name":497,"class":119},"Sir Run Run Shaw Hospital",{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":505,"phases":4,"briefSummary":506,"conditions":507,"keywords":512,"overallStatus":520,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":523,"locationsCount":4},"100573841","expanded-access-program-eap-designed-to-provide-access-to-botensilimab-and-balstilimab-before-regulatory-approval-100573841","NCT06751524","Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval","Botensilimab and Balstilimab Expanded Access Program","Key Inclusion Criteria:\n\n* The patient's disease is serious or life-threatening.\n* The patient has undergone appropriate standard treatments; there are no comparable or satisfactory alternative treatments for the disease or condition; the treatment is adjunct to an existing treatment option, and the treatment is not medically contra-indicated.\n* Sufficient efficacy and safety evidence exists to make a benefit-risk analysis consistent with this policy and the potential patient benefit justifies any potential risks of treatment.\n* Sufficient clinical data are available to identify an appropriate dose and treatment duration.\n* The patient's treating physician and qualified medical personnel at Agenus agree there is sufficient evidence to assume the potential benefit to the patient justifies potential risks.\n* The patient is not eligible for participation in an ongoing clinical trial of the investigational medicine, including lack of access due to geographic limitations.\n* Expanded Access will not adversely impact any clinical development program, in particular, the conduct of a pivotal clinical trial that is required for regulatory approval.\n* The request must be made by the patient's treating physician.\n\nNote: Other defined Inclusion\u002FExclusion criteria may apply.","EXPANDED_ACCESS","This is an expanded access program (EAP) designed to provide access to Botensilimab and Balstilimab prior to drug registration by the applicable local regulatory agency. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.",[32,397,508,137,509,279,510,511],"Non-Small Cell Lung Cancer (NSCLC)","Melanoma","Ovarian Cancer","Prostate Cancer",[513,514,515,516,517,518,519],"Compassionate Use","Early Access","Expanded Access","Managed Access","Pre-approval Access","Special Access","Named Patient Program (NPP)","AVAILABLE","2026-05-13",{"date":492,"type":46},{"name":524,"class":53},"Agenus Inc.",{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":22,"phases":534,"briefSummary":535,"conditions":536,"keywords":537,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":553},"100468454","phase-1-study-of-rmc-6236-in-patients-with-advanced-solid-tumors-harboring-specific-mutations-in-ras-100468454","NCT05379985","Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS","A Multicenter Open-Label Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS","Inclusion Criteria:\n\n* Histologically confirmed advanced solid tumor with specific KRAS G12 mutations (dose escalation) or RAS mutations (dose optimization\u002Fexpansion) identified through deoxyribonucleic acid (DNA) sequencing. PDAC with wild-type RAS (expansion).\n* Treatment naive or have received prior standard therapy appropriate for tumor type and stage\n* Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Primary central nervous system (CNS) tumors\n* Active, untreated brain metastases\n* Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication\n* History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and\u002For impact their ability to comply with the protocol prior\u002Fconcomitant therapy\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":533,"type":21},754,[24,25],"Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.",[30,32,335,28],[39,35,396,36,211,398,397,399,31,33,344,400,538,370,402,539,401,540,541,542,543,544,509,545,37],"Carcinoma, Pancreatic Ductal","Intestinal Neoplasms","Lung Neoplasms","Carcinoma, Non-Small-Cell Lung","Neoplastic Processes","Thoracic Neoplasms","Antineoplastic Agents","Gynecological Cancers","2026-05-12",{"date":492,"type":46},{"date":549,"type":46},"2022-05-31",{"date":551,"type":21},"2027-07-26",{"name":52,"class":53},21,{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":17,"minAge":561,"maxAge":562,"enrollmentInfo":563,"targetDuration":4,"studyType":565,"phases":4,"briefSummary":566,"conditions":567,"keywords":570,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":585},"100572506","care-crc-microbiome-insights-and-correlations-for-risk-and-outcomes-in-colorectal-cancer-100572506","NCT06734156","CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer","CARE-CRC","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent\n* Resident in Portugal\n* Age from 40 to 74 years\n* Have a recent diagnosis of CRC without initiating any treatment.\n\nExclusion Criteria:\n\n* Age \\\u003C 40 years or ≥ 75 years\n* Unable to provide informed consent\n* Refusal to provide stool samples\n* Previous or current treatment for CRC\n* First-degree family history of CRC\n* Previous diagnosis of inflammatory bowel disease (ulcerative colitis, Crohn's disease or indeterminate colitis), inflammatory bowel syndrome, recurrent infection by Clostridioides difficile\n* Pregnancy","40 Years","74 Years",{"count":564,"type":21},400,"OBSERVATIONAL","Colorectal cancer (CRC) is one of the leading causes of cancer-related deaths globally, with increasing incidence rates. While predominantly affecting older adults, CRC cases among individuals under 50 (early-onset CRC, or EoCRC) are rising. This age group rarely undergoes routine screening, resulting in delayed diagnoses and more advanced disease at presentation. In the USA, EoCRC accounts for 10% of CRC cases and is the leading cause of cancer-related deaths in men under 50.\n\nDespite the increase in EoCRC incidence, the causes remain unclear. Only 25% of cases have a CRC family history, suggesting environmental factors. Diets low in fibre and rich in fat and red meat, obesity, alcohol consumption, sedentary lifestyle, stress, and chronic inflammation of the GI tract are estimated to account for 70-90% of CRC risk. According to the World Cancer Research Fund, 47% of all CRC cases could be prevented through lifestyle changes, particularly in diet and physical activity.\n\nThese lifestyle factors are also strongly linked to changes in the gut microbiome, which differs markedly between CRC patients and healthy individuals. The microbiome may influence tumour development by producing metabolites that regulate immune responses or create anti-tumour environments. Thus, the gut microbiome is a promising target for early CRC detection and prevention.\n\nThis study aims to develop a non-invasive, microbiome-based diagnostic tool for CRC, identifying biomarkers to improve early detection, personalise treatment, and reduce healthcare costs.",[32,568,569],"Microbiome","Early Onset Colorectal Cancer",[36,571,568,572,573,574,575,576],"Gut Microbiota","Early-onset Colorectal Cancer","Biomarkers","Diet","Risk factors","Metagenomics","2026-05-11",{"date":546,"type":46},{"date":580,"type":46},"2026-03-02",{"date":582,"type":21},"2029-12-02",{"name":584,"class":119},"Gulbenkian Institute for Molecular Medicine",2,{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":97,"sex":17,"minAge":561,"maxAge":562,"enrollmentInfo":594,"targetDuration":4,"studyType":565,"phases":4,"briefSummary":596,"conditions":597,"keywords":599,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":89},"100573055","improving-colorectal-cancer-early-screening-in-portugal-identification-of-gut-microbiome-biomarkers-in-stool-gutbiome-pt-100573055","NCT06741293","Improving Colorectal Cancer Early Screening in Portugal: Identification of Gut Microbiome Biomarkers in Stool (GUTBIOME-PT)","Improving Colorectal Cancer Early Screening in Portugal: Identification and Validation of Biomarkers of Gut Microbiome in Stool","GUTBIOME-PT","Inclusion Criteria:\n\n* Ability to provide written informed consent and comply with study procedures\n* Reside in the Lisbon Metropolitan Area,, Portugal\n* Age from 40 to 74 years\n\nExclusion Criteria:\n\n* Age \\\u003C 40 years or ≥ 75 years\n* Unable to provide informed consent\n* Refusal to provide stool samples\n* Active oncological disease\n* Personal history of CRC\n* Personal history of colon adenomas removed in the last 24 months\n* First-degree family history of CRC\n* Previous diagnosis of inflammatory bowel disease (ulcerative colitis, Crohn's disease or indeterminate colitis), inflammatory bowel syndrome, persistent and infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhoea of unknown aetiology or recurrent infection by Clostridioides difficile\n* Severe cardiovascular or heart diseases with medical diagnosis\n* Severe renal failure requiring hemodialysis\n* Severe lung disease\n* Pregnancy",{"count":595,"type":21},30000,"Colorectal cancer (CRC) is a major public health problem, responsible for 2 million new cases and almost 1 million deaths annually worldwide. In Portugal, as of 2022, CRC is the most common cancer, with 10,575 new cases reported, and the second leading cause of cancer-related mortality, accounting for 4,809 deaths (approximately 14% of all cancer-related deaths). In recent years, there has been an alarming increase in the incidence and mortality of CRC in people \\\u003C50 years of age.\n\nEarly detection is crucial, as survival rates decline sharply from 90% when detected early to just 10% in advanced stages. Non-invasive diagnostic tests, such as the Faecal Immunochemical Test (FIT), have a low sensitivity for early-stage lesions and a high rate of false positives. Therefore, there is an urgent need to improve non-invasive diagnostic methods for the early detection of CRC, as effective screening can prevent it by detecting and removing premalignant lesions.\n\nRecent studies suggest that an altered gut microbiota may confer susceptibility to certain types of cancer. Interestingly, the gut microbiota of patients with adenomas or CRC differs from that of healthy individuals. This study aims to identify gut microbiome biomarkers in faecal samples associated with CRC and\u002For high-risk adenomas to improve early detection.",[598,32,568],"Colorectal Cancer Screening",[600,601,602,603,604],"colorectal cancer","microbiome","colorectal cancer screening","biomarkers","metagenomics",{"date":490,"type":46},{"date":607,"type":46},"2023-11-28",{"date":609,"type":21},"2029-11-28",{"name":584,"class":119},{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":617,"eligibilityCriteria":618,"healthyVolunteers":97,"sex":17,"minAge":619,"maxAge":159,"enrollmentInfo":620,"targetDuration":4,"studyType":565,"phases":4,"briefSummary":622,"conditions":623,"keywords":624,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":630,"completionDateStruct":631,"leadSponsor":633,"locationsCount":4},"100632595","raising-awareness-of-colorectal-screening-in-american-indian-communities-100632595","NCT07515729","Raising Awareness of Colorectal Screening in American Indian Communities","An American Indian Community-Engaged Approach to Increasing Diagnostic Colonoscopy","AIC-DC","Inclusion Criteria:\n\n* Inclusion for patient interviews: American Indian Men and Women eligible for services at OKCIC and IHS facilities. American Indian Men and Women aged 45 to 75 years who are eligible for colorectal cancer screening.\n* Inclusion for the provider\u002Fstaff\u002Fleadership interviews: Adults (18 to 80 years old) who are employed by the participating clinic.\n* Inclusion for caregiver\u002Fcommunity member interviews: Adults aged 18 and over who are caregivers for patients eligible for CRC screening. Community members who are aged 18 and over.\n\nExclusion Criteria:\n\n* Exclusion for patient interviews: Non-American Indian Men and Women and American Indian Men and Women that are not in the required age range for CRC screenings.\n* Exclusion for provider\u002Fstaff\u002Fleadership interviews: Employees less than 18 years old or people not employed by the participating clinics.\n* Exclusion for caregivers\u002Fcommunity members: People less than 18 years old, not a caregiver for a patient eligible for CRC screening. People less than 18 years old and not a member of the community where the participating clinics are located.","45 Years",{"count":621,"type":21},446,"This study focuses exclusively on American Indian individuals within their communities to enhance health equity and address a critical tribal health priority. American Indian populations experience some of the highest colorectal cancer (CRC) mortality rates in the nation. By conducting research within these communities, this study aims to improve early detection, prevention, and treatment strategies tailored to their specific needs. The findings will help develop targeted interventions to reduce CRC disparities and improve health outcomes for American Indian individuals.",[32],[625,626,627],"American Indian (AI)","Implementation Science (IS)","Alaskan Native (AN)","2026-05-08",{"date":577,"type":46},{"date":172,"type":21},{"date":632,"type":21},"2030-06",{"name":634,"class":119},"University of Oklahoma",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":159,"enrollmentInfo":642,"targetDuration":4,"studyType":22,"phases":644,"briefSummary":645,"conditions":646,"keywords":647,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":89},"100627400","phase-2-low-dose-radiotherapy-to-sensitize-pucotenlimab-plus-capeox-for-pmmr-locally-advanced-rectal-cancer-100627400","NCT07448142","Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer","A Randomized, Two-Arm, Open-Label Phase II Trial of Low-Dose Radiotherapy Sensitization Combined With Pucotenlimab and CAPEOX as Neoadjuvant Therapy for pMMR\u002FMSS Locally Advanced Rectal Adenocarcinoma","Inclusion Criteria\n\n* Written informed consent provided prior to any study-specific procedures.\n* Age 18 to 75 years at the time of enrollment.\n* Histologically confirmed rectal adenocarcinoma.\n* Tumor located within 10 cm from the anal verge, as assessed by endoscopy or imaging.\n* Locally advanced disease, defined as clinical stage T2N+ or T3-T4a (any N) based on pelvic magnetic resonance imaging (MRI).\n* Proficient mismatch repair (pMMR) or microsatellite-stable (MSS) tumor status confirmed by immunohistochemistry or molecular testing.\n* No evidence of distant metastasis on preoperative imaging, including chest, abdominal, and pelvic computed tomography (CT).\n* Circumferential resection margin (CRM) ≥2 mm and no involvement of the mesorectal fascia on baseline MRI.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Adequate organ function as defined by:\n* Absolute neutrophil count ≥1.5 × 10⁹\u002FL\n* Platelet count ≥100 × 10⁹\u002FL\n* Hemoglobin ≥90 g\u002FL\n* Total bilirubin ≤1.5 × upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN\n* Creatinine clearance ≥50 mL\u002Fmin\n* Thyroid-stimulating hormone (TSH) within normal limits\n* Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a protocol-defined period after the last dose.\n* Men with partners of childbearing potential must agree to use effective contraception during the study and for a protocol-defined period after the last dose.\n\nExclusion Criteria\n\n* Clinical T4b disease, defined as tumor invasion into adjacent organs or structures on baseline imaging.\n* Circumferential resection margin (CRM) \\\u003C2 mm or definite involvement of the mesorectal fascia on baseline MRI.\n* Evidence of distant metastasis outside the pelvis.\n* Prior pelvic or abdominal radiotherapy.\n* Prior treatment with immune checkpoint inhibitors or other systemic anticancer therapy for rectal cancer.\n* Active or history of autoimmune disease requiring systemic treatment, except for conditions considered low risk for recurrence (e.g., vitiligo, resolved childhood asthma).\n* Ongoing use of systemic immunosuppressive therapy, including corticosteroids equivalent to \\>10 mg\u002Fday of prednisone, within 2 weeks prior to enrollment.\n* Known human immunodeficiency virus (HIV) infection.\n* Active hepatitis B virus infection with positive hepatitis B surface antigen and high viral load, or hepatitis C virus infection requiring treatment.\n* Uncontrolled active infection or other serious medical condition that, in the investigator's judgment, would compromise patient safety or study compliance.\n* History of another malignancy within 5 years, except for adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies with negligible risk of recurrence.\n* Known hypersensitivity or allergy to pucotenlimab, oxaliplatin, capecitabine, or any of their excipients.\n* Pregnant or breastfeeding women.\n* Any condition that, in the investigator's opinion, makes the participant unsuitable for study participation.",{"count":643,"type":21},50,[25],"This is a prospective, open-label, randomized, parallel-group phase II trial evaluating the efficacy and safety of a low-dose radiotherapy sensitization strategy combined with a PD-1 antibody (pucotenlimab) and CAPEOX as neoadjuvant therapy in patients with pMMR\u002FMSS locally advanced rectal adenocarcinoma. Participants will be randomized 1:1 to receive either 2 Gy or 5 Gy low-dose radiotherapy. Low-dose radiotherapy is delivered as a single fraction of 2 Gy (Arm A) or 5 Gy (Arm B). On the day after radiotherapy, participants will start pucotenlimab 200 mg IV Q3W (administered on Day 2 of each 21-day cycle) plus CAPEOX chemotherapy. Early response will be assessed after 2 cycles using endoscopy and pelvic MRI to guide subsequent treatment: participants with partial response may discontinue radiotherapy and continue neoadjuvant systemic therapy; participants with stable disease may switch to standard chemoradiotherapy; participants with progressive disease will receive multidisciplinary-team-guided salvage therapy. After 4 cycles, participants with clinical complete response may adopt a watch-and-wait strategy; otherwise, they will undergo radical surgery 2-4 weeks after completion of neoadjuvant therapy. Long-term follow-up will include recurrence and survival outcomes and quality of life.",[32],[214,648,649,650,651,652,653,654,655,656,657],"Neoadjuvant therapy","Low-dose radiotherapy","Immunotherapy","Pucotenlimab","CAPEOX","Total neoadjuvant therapy","Organ preservation","Complete Response Rate","Disease-free survival","Overall survival","2026-05-01",{"date":660,"type":46},"2026-05-07",{"date":662,"type":46},"2026-03-15",{"date":664,"type":21},"2032-09-01",{"name":666,"class":119},"Sun Yat-sen University",{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":672,"acronym":673,"eligibilityCriteria":674,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":305,"enrollmentInfo":675,"targetDuration":4,"studyType":22,"phases":676,"briefSummary":677,"conditions":678,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":682,"startDateStruct":683,"completionDateStruct":685,"leadSponsor":687,"locationsCount":89},"100636205","phase-2-randomized-controlled-study-of-plasma-ctdna-methylation-guided-adjuvant-chemotherapy-in-stage-ilow-risk-stage-ii-colorectal-cancer-100636205","NCT07562659","Randomized Controlled Study of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy in Stage I\u002FLow-Risk Stage II Colorectal Cancer","A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decisions in Postoperative Stage I or Low-Risk Stage II Colorectal Cancer Patients","CLEAR-01","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n1. Age ≥18 years, regardless of sex;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of \\>3 months;\n3. Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer;\n4. Positive ctDNA status at 1 month after surgery;\n5. Expected survival of \\>12 months;\n6. Ability to understand and willingness to sign a written informed consent form (personally or via a legally authorized representative\u002Fguardian), indicating that the subject understands the study objectives and required procedures and agrees to participate.\n\nExclusion Criteria:\n\n1. Receipt of neoadjuvant therapy prior to surgery;\n2. Blood transfusion during surgery or within 2 weeks prior to surgery;\n3. Pregnant or breastfeeding women, or individuals of reproductive potential who are not using adequate contraception;\n4. History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer;\n5. Uncontrolled primary brain tumors or central nervous system metastases, or presence of significant intracranial hypertension or neuropsychiatric symptoms;\n6. Presence of severe or uncontrolled comorbidities, including but not limited to:Severe cardiac disease that remains unstable despite treatment, including myocardial infarction, congestive heart failure, unstable angina, symptomatic pericardial effusion, or unstable arrhythmia within 6 months prior to enrollment; Clearly diagnosed neurological or psychiatric disorders, including dementia or seizure disorders;Severe or uncontrolled infections;Active disseminated intravascular coagulation (DIC) or significant bleeding tendency;Significant impairment of major organ function; Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.",{"count":240,"type":21},[25],"This study will utilize ctDNA methylation detection to evaluate patients with stage I or low-risk stage II colorectal cancer who are ctDNA-positive one month after surgery. It aims to investigate the impact of different adjuvant chemotherapy regimens on ctDNA clearance rates and their prognostic significance. By using postoperative ctDNA status to identify patients at high risk of recurrence, the study seeks to implement intensified chemotherapy strategies (treatment escalation) at an early stage, thereby improving ctDNA clearance and ultimately enhancing patient outcomes.",[679,32,680],"ctDNA","Adjuvant Chemotherapy","2026-04-25",{"date":658,"type":46},{"date":684,"type":46},"2024-11-01",{"date":686,"type":21},"2027-12-31",{"name":688,"class":119},"Fudan University",{"id":690,"slug":691,"hasResults":12,"nctId":692,"briefTitle":693,"officialTitle":694,"acronym":4,"eligibilityCriteria":695,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":696,"targetDuration":4,"studyType":22,"phases":697,"briefSummary":698,"conditions":699,"keywords":704,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":706,"lastUpdatePostDateStruct":707,"startDateStruct":709,"completionDateStruct":711,"leadSponsor":713,"locationsCount":4},"100634670","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-kqb368-as-monotherapy-in-participants-with-advanced-solid-malignancies-100634670","NCT07542704","A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies","A Phase 1\u002F1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB368 in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations","* Histologically confirmed diagnosis of a solid tumor\n* Malignancy with either a KRAS G12C or KRAS G12S mutation\n* Unresectable or metastatic disease\n* No available treatment with curative intent\n* Adequate organ function\n* Measurable disease per RECIST v1.1\n* Must be able to swallow with no GI condition that prevents absorption",{"count":185,"type":21},[24],"The goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are:\n\n* What is the safe dose of KQB368 as a monotherapy?\n* Does KQB368 decrease the size of the tumor?\n* What happens to KQB368 in the body?\n\nParticipants will:\n\n* Take KQB368 orally daily in 21-day cycles\n* Return to the study site about 7 times in the first 5 weeks, and then once at the beginning of every 21-day cycle after that",[28,32,700,701,702,703],"Non-Small Cell Lung Cancer","Uterine Cancer","KRAS G12C Mutations","KRAS G12S Mutations",[705],"KQB368","2026-04-17",{"date":708,"type":46},"2026-04-21",{"date":710,"type":21},"2026-05",{"date":712,"type":21},"2029-12",{"name":714,"class":53},"Kumquat Biosciences Inc."]