Clinical Trial: A phase II study of sotorasib plus panitumumab rechallenge in patients with KRAS G12C mutant metastatic colorectal cancer (Japan)

Tokyo, Aug. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062434) titled 'A phase II study of sotorasib plus panitumumab rechallenge in patients with KRAS G12C mutant metastatic colorectal cancer' on Aug. 3.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Aichi Cancer Center

Condition: Condition - Colorectal cancer Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - To evaluate the clinical efficacy and safety of sotorasib plus panitumumab rechallenge in patients with KRAS G12C mutant metastatic colorectal cancer Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Sotorasib is administered orally at a dose of 960 mg once daily. Panitumumab is administered as an intravenous infusion at a dose of 6 mg/kg every 2 weeks. Each treatment cycle is 14 days.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not amenable to curative resection, excluding appendiceal and anal canal cancers 2. KRAS G12C mutation confirmed by RAS mutation testing performed using tumor tissue 3. Prior treatment with a fluoropyrimidine-containing systemic therapy that included oxaliplatin or irinotecan. Patients with microsatellite instability-high (MSI-H) tumors must also have received prior treatment with an anti-PD-1 antibody 4. Prior treatment with combination therapy comprising a KRAS G12C inhibitor and an anti-EGFR antibody, with a best overall response of CR, PR, or SD lasting at least 5 months 5. Radiographic progressive disease (PD) or clinical progression of the underlying disease confirmed within 6 weeks after the last dose of the KRAS G12C inhibitor, followed by at least one subsequent systemic therapy regimen 6. An interval of at least 4 months between the last dose of the KRAS G12C inhibitor and the initiation of protocol treatment 7. At least one measurable lesion according to the RECIST version 1.1 8. ECOG PS of 0-2 9. Age of 18 years or older at the time of informed consent 10. Ability to take oral medication 11. Life expectancy of at least 3 months 12. Adequate organ function 13. Written informed consent for participation in the study provided by the patient after receiving an adequate explanation of the study 14. Written informed consent for blood collection for ctDNA analysis provided by the patient after receiving an adequate explanation of the procedure Key exclusion criteria - 1. Concurrent malignancy requiring treatment 2. Symptomatic, unstable, or clinically uncontrolled metastases to the central nervous system, including the brain, spinal cord, or meninges 3. Ascites, pleural effusion, or pericardial effusion requiring drainage 4. Localized infection requiring treatment or active systemic infection 5. Clinically significant psychiatric disorder that, in the investigator's judgment, would preclude participation in the study 6. Interstitial pneumonitis or pulmonary fibrosis requiring treatment 7. Planned initiation of protocol treatment before the scheduled date of the next dose of the most recent anticancer therapy 8. Unresolved adverse events of CTCAE Grade 2 or higher resulting from prior therapy, except for anemia, alopecia, skin hyperpigmentation, oxaliplatin-induced peripheral neuropathy, and hypertension or proteinuria caused by angiogenesis inhibitors 9. History of a serious allergic reaction to a KRAS G12C inhibitor or an anti-EGFR antibody 10. History of myocardial infarction or unstable angina within 6 months before enrollment 11. Women who are pregnant, breastfeeding, may currently be pregnant, or are unwilling to use adequate contraception 12. Any other condition that, in the judgment of the principal investigator or a subinvestigator, makes the patient unsuitable for participation in the study Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 22 Day Anticipated trial start date - 2026 Year 08 Month 03 Day Last follow-up date - 2028 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071345

Disclaimer: Curated by HT Syndication.