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

JAB-21822-1002

To assess safety, tolerability, PK, efficacy and determine recommended phase 2 dose (RP2D) of JAB-21822 (glecirasib) administered in adult participants with KRAS p.G12C-mutant advanced solid tumors.

2021-07-26

2025-12-01

2025-12-01

Active (not recruiting)

Early phase I

311

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. Intended study subjects who were unable to abstain from alcohol during medication 9. Other unqualified conditions judged by the investigators

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 311, 'type': 'ESTIMATED'}}

2024-06-14