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A Phase Ib/II Trial of JAB-21822 in Combination With Cetuximab in Patients With Advanced Colorectal Cancer, Small Intestine Cancer and Appendiceal Cancer With KRAS G12C Mutation
This study is to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of JAB-21822 in combination with cetuximab in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.
Details
| Lead sponsor | Allist Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 48 |
| Start date | 2022-02-17 |
| Completion | 2026-12 |
Conditions
- Advanced Colorectal Cancer
- Small Intestinal Cancer
- Appendiceal Cancer
Interventions
- JAB-21822
- Cetuximab
Primary outcomes
- Dose Escalation phase: Number of participants with dose-limiting toxicities (DLTs) — At the end of Cycle 1 (each cycle is 21 days)
A DLT is defined as the clinically significant treatment related adverse event (TRAE) or abnormal laboratory values assessment during the first 21 days of (Cycle 1) and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness. - Dose Expansion phase: Overall response rate (ORR) — Up to 4 years - from baseline to RECIST confirmed Progressive Disease
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1.
Countries
China