Status:
ACTIVE_NOT_RECRUITING
JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation
Lead Sponsor:
Allist Pharmaceuticals, Inc.
Conditions:
Advanced Colorectal Cancer
Small Intestinal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 intest...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05194995
Start Date
February 17 2022
End Date
January 1 2026
Last Update
April 4 2025
Active Locations (17)
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1
Research site31
Beijing, Beijing Municipality, China, 100021
2
Research site01
Beijing, Beijing Municipality, China, 100101
3
Research site02
Beijing, Beijing Municipality, China, 100101
4
Research site12
Beijing, Beijing Municipality, China, 100101