Overview

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