A Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation in China
Multi-center, Open, Dose-escalation, and Expanded Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JAB-21822 in Advanced Solid Tumors With KRAS p.G12C Mutation
Sponsor: Allist Pharmaceuticals, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase
Time frame: first 21 days
Number of participants with adverse events
Time frame: up to 3 years
Overall response rate (ORR) by IRC (independent review committee)
Time frame: up to 3 years
Secondary Endpoints
Overall response rate (ORR) by investigator
Duration of response ( DOR )
Disease Control Rate ( DCR )
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent 2. Advanced (metastatic or unresectable) KRAS p.G12C mutant solid tumors, with failure or absence of standard treatment 3. Subject must be ≥18 years 4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 5. Subjects with life expectancy ≥3 months. 6. Subjects must have at least one measurable lesion as defined by RECIST v1.1. 7. There was no serious organ dysfunction in the screening stage 8. Male or female subjects of reproductive age agree to use adequate contraception Exclusion Criteria: 1. History of intestinal disease or major gastric surgery or inability to swallow oral medications 2. Other active cancer 3. Previously treated with KRAS G12C inhibitor 4. Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV) 5. Impaired heart function or clinically significant heart disease 6. Pregnant or breast-feeding 7. Previous allogeneic bone marrow transplant or organ transplant 8…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →