[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kras-g12c-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kras-g12c-mutation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100571494","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-kqb365-as-monotherapy-and-in-combination-in-participants-with-advanced-solid-malignancies-100571494",false,"NCT06720987","A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies","A Phase 1\u002F1b, Open-label, Multicenter, Dose Escalation and Dose Optimization Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB365 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations","Inclusion Criteria:\n\n* PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.\n* PART 1 (combo therapy with Cetuximab) \\& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum 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\nExclusion Criteria:\n\n* Active primary central nervous system tumors\n* Cardiac abnormalities\n* Active interstitial lung disease\n* Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts","ALL","18 Years",{"count":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are:\n\n* What is the safe dose of KQB365 by itself, in combination with cetuximab, or in combination with KQB198?\n* Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor?\n* What happens to KQB365 in the body?\n\nParticipants will:\n\n* Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198.\n* Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.",[26,27,28,29],"KRAS G12C Mutation","KRAS G12S Mutation","Solid Tumor Malignancies","CRC (Colorectal Cancer)",[31,32,33],"cetuximab","KQB365","KQB198","RECRUITING","2026-04-20",{"date":37,"type":38},"2026-04-23","ACTUAL",{"date":40,"type":38},"2025-02-04",{"date":42,"type":20},"2030-06-30",{"name":44,"class":45},"Kumquat Biosciences Inc.","INDUSTRY",11,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":5},"100630797","phase-2-fulzerasib-sequential-sintilimab-plus-platinum-doublet-neoadjuvant-therapy-for-resectable-kras-g12c-mutant-nsclc-100630797","NCT07492342","Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC","Evaluation of Efficacy and Safety of Fulzerasib Sequentially Combined With Sintilimab Plus Platinum-Doublet Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Non-Small Cell Lung Cancer With KRAS G12 Mutation: a Single-Arm, Phase II Clinical Trial","K-NADIR","Inclusion Criteria:\n\n1. Sign the Informed Consent Form (ICF) and be able to comply with the visit and related procedures as stipulated in the protocol.\n2. Be male or female, aged ≥18 years old.\n3. Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC).\n4. Clinical stage IB to IIIA disease, according to the 8th edition of the TNM classification for lung cancer as defined by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).\n5. All subjects must have a written test report before enrollment to prove the presence of KRAS G12C mutation; and must have no sensitive mutations of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK).\n6. The patient is deemed by a thoracic surgeon to be a candidate for curative resection (R0 resection) and has adequate pulmonary function to undergo the planned pulmonary resection.\n7. Have at least one measurable lesion according to RECIST 1.1 criteria.\n8. Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.\n9. Have not received any systemic anti-tumor treatment for locally advanced or metastatic NSCLC before.\n10. Have adequate organ and bone marrow function (subjects who have received any cell or growth factor therapy within 2 weeks before the first administration of the study drug should be excluded), defined as follows:\n\n1\\) Blood routine: Absolute neutrophil count (ANC) ≥1.5×109\u002FL or within the normal range; platelet (PLT) count ≥100×109\u002FL; hemoglobin (HGB) content ≥9.0 g\u002FdL.\n\n2\\) Liver function: Serum total bilirubin (TBIL) ≤1.5×Upper Limit of Normal Value (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN.\n\n3\\) Renal function: Serum creatinine (Cr) ≤1.5×ULN or clearance of creatinine (CCr) ≥50 mL\u002Fmin, calculated by the Cockcroft-Gault formula (using actual body weight); urine routine test shows urine protein \\\u003C2+; for subjects with urine protein ≥2+ at baseline as detected by urine test strips, a 24-hour urine collection should be performed and the protein content in 24-hour urine should be \\\u003C1 g (if both methods are used, the value obtained from 24-hour urine collection will be used to determine eligibility).\n\n4\\) Coagulation function: Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN and International Normalized Ratio (INR) ≤ 1.5; 11. Female subjects of childbearing age or male subjects whose partners are of childbearing age must take effective contraceptive measures throughout the treatment period and for 180 days after the treatment.\n\n12.Female subjects have evidence of postmenopausal status, or the urine or serum pregnancy test results of premenopausal female subjects are negative.\n\nExclusion Criteria:\n\n1. Histological or cytological pathology confirms the presence of small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelioma-like carcinoma, salivary gland tumors, or mesenchymal tumor components.\n2. Tumor invasion of the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, or carina.\n3. Superior sulcus (Pancoast) tumor.\n4. Presence of tumor nodules in the contralateral lung lobe. Biopsy is required to confirm if contralateral lung nodules are clinically suspected.\n5. Documented brain metastasis. Patients with suspected brain metastasis must undergo brain imaging for further confirmation.\n6. Have significant cardiovascular or cerebrovascular diseases, such as:\n\n1)Experienced definite cardiovascular abnormal events within 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or undergone angioplasty, vascular stent implantation, coronary artery bypass surgery, etc.\n\n2)Have clinically significant QT\u002FQTcF interval prolongation (QTcF \\> 470ms for females or \\> 450ms for males).\n\n7.Significant or active gastrointestinal disease characterized by diarrhea as the major symptom.\n\n8.Receipt of strong inhibitors or strong inducers of CYP3A4 or P-gp within 14 days prior to the first dose of study treatment, or within 5 half-lives of such agents (whichever is longer), or use of traditional Chinese medicine within 7 days prior to the first dose of study treatment.\n\n9.Participants who have received known CYP2D6, CYP3A4, P-gp, and BCRP sensitive substrates within 14 days or 5 half-lives (whichever is longer) before the first dose of this study, and the therapeutic window of the substrate is narrow, unless agreed by the investigator and the sponsor to be enrolled.\n\n10.Receipt of proton pump inhibitors (PPIs) or H2 receptor antagonists within 7 days prior to the first dose of study treatment.\n\n11.Systemic therapy with Chinese herbal medicines with anti-tumor indications or immunomodulatory agents (including thymopeptides, interferons, interleukins) within 2 weeks prior to the first dose of study treatment.\n\n12.Participants who are simultaneously involved in another interventional clinical study, except for observational (non-interventional) clinical studies or those in the follow-up stage after the end of an interventional study.\n\n13.Participants who have received live attenuated vaccines within 4 weeks before the first dose of study treatment or plan to receive them during the study period.\n\nNote: Inactivated virus vaccines for seasonal influenza by injection are allowed within 4 weeks before the first dose of study treatment; however, live attenuated influenza vaccines are not allowed.\n\n14.Patients requiring long-term systemic corticosteroid use. Any other form of immunosuppressive therapy within 7 days prior to randomization.\n\nNote: Topical glucocorticoids (nasal, inhaled, or other routes), physiological doses of systemic glucocorticoids (≤10 mg\u002Fday prednisone or equivalent), or use for pre-medication (e.g., prevention of contrast agent allergy) are permitted.\n\n15.Major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or presence of non-healing wounds, ulcers, or fractures.\n\n16.History of radiation pneumonitis, idiopathic pneumonitis, active pneumonitis, pulmonary fibrosis, diffuse interstitial lung disease, or organizing pneumonia (e.g., bronchiolitis obliterans).\n\n17.Participants with known allergies to study treatment or any of its components.\n\n18.Known primary immunodeficiency. 19.Active autoimmune or inflammatory disease (including inflammatory bowel disease \\[e.g., colitis, Crohn's disease\\], diverticulitis \\[excluding diverticulosis\\], celiac disease, systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis (Wegener's syndrome), Graves' disease, hypophysitis, uveitis, etc.), or history of such disease within the previous 2 years.\n\nPatients with vitiligo, psoriasis, alopecia that do not require systemic therapy within the past 2 years, hypothyroidism requiring only thyroid hormone replacement, and type 1 diabetes mellitus requiring only insulin replacement are eligible.\n\n20.Have major acute or chronic infections, including:\n\n1. Active infections requiring systemic treatment;\n2. Positive human immunodeficiency virus antibody (HIV-Ab) at baseline;\n3. Active hepatitis B virus (HBV) infection (positive HBsAg and positive HBV-DNA). For patients with negative HBsAg and positive HBcAb, HBV-DNA testing is required; patients with positive HBV-DNA are excluded;\n4. Active hepatitis C virus (HCV) infection (positive HCV-Ab and positive HCV-RNA);\n5. Active pulmonary tuberculosis,, receiving anti-tuberculosis therapy, or having received anti-tuberculosis therapy within 1 year prior to the first dose of study treatment\n6. Active syphilis. 21.History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\n22.Diagnosis of another malignancy within 5 years prior to the first dose,except for radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,radically resected carcinoma in situ, radically treated localized prostate cancer, papillary thyroid carcinoma, and similar diseases.\n\n23.Uncontrolled concurrent disease, including:\n\n1)Serious infection occurring within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; or therapeutic oral or intravenous antibiotics administered within 2 weeks prior to initiation of study treatment; 2)Symptomatic congestive heart failure (New York Heart Association Class III-IV), left ventricular ejection fraction (LVEF) \\\u003C 50% by echocardiography, or uncontrolled cardiac arrhythmia; 3)Uncontrolled hypertension despite standard therapy (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg); 4)Uncontrolled or symptomatic hypercalcemia (\\>1.5 mmol\u002FL ionized calcium, or serum calcium \\>12 mg\u002FdL, or corrected serum calcium \\> ULN); 5)Esophageal or gastric varices requiring immediate intervention (e.g., banding or sclerotherapy), or subjects with evidence of portal hypertension (including splenomegaly on imaging) or a history of variceal bleeding considered to be at high risk of bleeding by the investigator or in consultation with a gastroenterologist or hepatologist; endoscopic evaluation must be performed within 3 months prior to enrollment; 6)History of deep vein thrombosis or any other severe thromboembolism within 3 months prior to enrollment (implanted venous access port or catheter-related thrombosis, or superficial venous thrombosis is not considered severe); 7）Any life-threatening hemorrhagic event within 3 months prior to enrollment; 8)Uncontrolled metabolic disorders or other acute or chronic non-malignant organ or systemic diseases, or paraneoplastic syndromes that may confer high medical risk and\u002For uncertainty in survival assessment; 9)History of gastrointestinal perforation and\u002For fistula within 6 months prior to enrollment; 10)Subjects at risk of intestinal obstruction or perforation (including but not limited to acute diverticulitis, intra-abdominal abscess, history of intra-abdominal cancer), or history of extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea; 11)Significant malnutrition requiring intravenous nutritional supplementation, unless malnutrition had been corrected for more than 4 weeks prior to the first dose of study treatment; 12)Post-placement of intraluminal esophageal or tracheal stents; 13)Other acute or chronic medical conditions that may increase risk related to study participation or study drug administration, interfere with the interpretation of study results, or are deemed by the investigator to render the subject ineligible for the study; 14)Neurological, psychiatric, or social conditions that would impair compliance with study requirements, significantly increase the risk of adverse events, or affect the subject's ability to provide written informed consent (e.g., schizophrenia, history of drug abuse, etc.).\n\n24.Pregnant or lactating women",{"count":56,"type":20},30,[58],"PHASE2","This is an exploratory study evaluating the efficacy and safety of neoadjuvant therapy with fulzerasib sequentially combined with sintilimab plus platinum-doublet chemotherapy in patients with resectable non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation.\n\nApproximately 30 treatment-naïve patients with stage IB-IIIA (AJCC 8th edition) NSCLC and confirmed KRAS G12C mutation will be enrolled.\n\nEligible subjects will receive 6 weeks of fulzerasib followed by a 2-week washout period, then 3 cycles (q3w) of sintilimab plus investigator's choice of platinum-doublet chemotherapy.\n\nAn end-of-treatment visit will be performed within 7 days after the last dose of neoadjuvant therapy.",[61,26,62,63],"Resectable NSCLC","Stage IB-IIIA NSCLC","Neoadjuvant Therapy",[63,65,66,67],"Fulzerasib","Sintilimab","Platinum-Based Combination Chemotherapy","2026-03-19",{"date":70,"type":38},"2026-03-25",{"date":72,"type":38},"2026-01-29",{"date":74,"type":20},"2027-12-31",{"name":76,"class":77},"Jianxing He","OTHER",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100602543","phase-2-5-fluorouracil-plus-panitumumab-anti-egfr-and-sotorasib-kras-g12c-inhibitor-in-first-line-treatment-of-patients-non-eligible-for-a-doublettriplet-chemotherapy-with-advanced-unresectab-100602543","NCT07124884","5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet\u002FTriplet Chemotherapy With Advanced Unresectab","COLOSOTO: Single-arm Phase II Study Evaluating 5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet\u002FTriplet Chemotherapy With Advanced Unresectab","COLOSOTO","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically proven advanced-stage unresectable locally advanced or metastatic colorectal adenocarcinoma.\n* Proven KRAS G12C mutation as locally assessed by means of an IVDR-compliant test\n* Agreement to participate to biological studies (blood samples for ctDNA and send tumour block).\n* Patient with one these criteria:\n\nPatient with WHO PS=2 Patient between 70 and 75 years old with WHO PS 1 Patient ≥ 75 years old\n\n* Measurable lesion according to the Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1).\n* No prior treatment for the metastatic disease. Prior adjuvant chemotherapy is allowed if there is more than 6 months between the end of adjuvant treatment and relapse.\n* Adequate organ function: Hemoglobin \\> 9 g\u002Fdl, Absolute neutrophil count \\> 1500 \u002Fmm3, Platelets \\> 80 000\u002Fmm3, Creatinine clearance rate ≥50 mL\u002Fmin as calculated using MDRD formula, ALT\u002FAST ≤5×ULN and total bilirubin ≤1.5×ULN.\n* Ability to understand and sign written informed consent to participate in the study.\n* Provides written informed consent for the study.\n* Life expectancy \\>6 months.\n* Women of childbearing potential must agree to use contraception during the trial treatment and for at least 6 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 3 months after discontinuation of the experimental treatments.\n* Patient affiliated to a social security scheme for France, or equivalent for other countries.\n\nExclusion Criteria:\n\n\\- Patient with one of these criteria: Patient fit for doublet\u002Ftriplet regimen Patient with WHO PS 3 or 4 Patient \\\u003C 75 years old with WHO PS 0 Patient \\\u003C 70 years old with WHO PS 0 or 1\n\n* Uncontrolled intercurrent illness including liver (liver cirrhosis Child Pugh B or C) and lung (one second forced expiratory volume \\\u003C50%) severe insufficiency.\n* Patients with high microsatellite instability (MSI-H) or a tumour with mismatched repair (dMMR).\n* Clinically significant cardiac abnormalities including prior history of any of the following: severe cardiomyopathy, congestive heart failure of New York Heart Association grade ≥3, history of clinically significant (i.e., active) atherosclerotic cardiovascular disease (myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study treatments).\n* Patients with Dihydropyrimidine Dehydrogenase (DPD) enzyme deficiencies (uracilemia ≥ 16 ng\u002FmL).\n* Immunotherapy within 3 months before the beginning of the treatment study.\n* Patient under treatment by strong CYP3A4 inducers.\n* Patients treated by brivudine within 4 weeks before the first dose of study treatment, or concomitant treatment with brivudine.\n* Patient with potentially serious infection.\n* Administration of live or live attenuated vaccine within 30 days prior to the first dose of study treatment start.\n* Poor nutritional state (albuminemia \\\u003C 25 g\u002FL or weight loss \\> 10% during the last month).\n* Hereditary problems of galactose intolerance, total lactase deficiency or glucose galactose malabsorption.\n* Other malignancy within 2 years prior to study enrolment, except for localized cancer in situ, basal or squamous cell skin cancer adequately treated.\n* Less than 4 weeks from major surgeries and not recovered adequately from the procedure and\u002For any complications from the surgery.\n* Patients with persistent toxicities related to prior treatment of grade greater than 1.Is c urrently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks or 5 half-lives (whichever longer) before study entry.\n* Hypersensitivity to one of the active substances or to one of the excipients of the trial treatments.\n* Patient with interstitial lung disease or pulmonary fibrosis.\n* Patients with history of interstitial pneumonitis or pulmonary fibrosis.\n* Has a known psychiatric or substance abuse disorder that would interfere with the patient's ability to cooperate with the requirements of the study.\n* Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent.\n* Pregnant or breastfeeding woman.\n* Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons.",{"count":87,"type":20},300,[58],"5-fluorouracil (5-FU) is a standard of care in frail\u002Felderly patients with an unresectable colorectal adenocarcinoma (CRC) in first-line setting. Panitumumab plus Sotorasib are promising in advanced line in KRAS G12C mutated CRC. In this study, We assess the safety and efficacy of 5FU combination with Panitumumab and Sotorasib as first-line treatment in frail\u002Felderly patients with unresectable KRAS G12C mutated CRC",[91,26,92],"Colorectal Carcinoma","Unresectable Colorectal Cancer",[94,95,96],"sotorasib","colorectal cancer","KRAS G12C","NOT_YET_RECRUITING","2025-08-14",{"date":100,"type":38},"2025-08-15",{"date":102,"type":20},"2025-08-31",{"date":104,"type":20},"2030-12-30",{"name":106,"class":77},"Federation Francophone de Cancerologie Digestive",80]