Trials / Active Not Recruiting
Active Not RecruitingNCT05194995
JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation
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
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Allist Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 in combination with cetuximab to determine the MTD and RP2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 is administered in combination with cetuximab during Dose Expansion phase in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JAB-21822 | JAB-21822 administered orally as a tablet. |
| DRUG | Cetuximab | Cetuximab administered as an intravenous (IV) infusion. |
Timeline
- Start date
- 2022-02-17
- Primary completion
- 2025-04-30
- Completion
- 2026-12-01
- First posted
- 2022-01-18
- Last updated
- 2026-03-16
Locations
17 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05194995. Inclusion in this directory is not an endorsement.