JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation

• Status: Not yet recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jacobio Pharmaceuticals Co., Ltd.
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Participants must be able to provide an archived tumor sample

• Histologically or cytologically confirmed advanced colorectal cancer, advanced small intestinal cancer and advanced appendiceal cancer with KRAS p.G12C mutation

• Must have received at least 1 prior standard therapy

• Must have at least 1 measurable lesion per RECIST v1.1

• Must have adequate organ function

• Must be able to swallow and retain orally administered medication

Exclusion Criteria:

• Has brain metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days

• Active infection requiring systemic treatment within 14 days

• Active HIV, HBV or HCV

• Any severe and/or uncontrolled medical conditions

• LVEF<50% assessed by ECHO

• QT interval >470 msec