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
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Research site01
Beijing
Research site02
Beijing
Research site12
Beijing
Research site31
Beijing
Research site11
Changsha
Research site29
Changsha
Research site19
Hangzhou
Research site06
Harbin
Research site16
Linyi
Research site08
Nanchang
Research site09
Nanjing
Research site13
Nanning
Research site28
Shanghai
Research site18
Wuhan
Research site23
Xi’an
Research site05
Zhengzhou
Research site07
Zhengzhou
Time Frame
Start Date: 2022-02-17
Completion Date: 2026-01
Participants
Target number of participants: 48
Treatments
Experimental: Phase 1b Dose Escalation
Dose escalation of JAB-21822 to determine maximum tolerated dose of JAB-21822 in combination with cetuximab.
Experimental: Phase 2 Dose Expansion, Cohort 1
Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.
Experimental: Phase 2 Dose Expansion, Cohort 2
Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced small intestinal cancer and advanced appendiceal cancer.
Related Therapeutic Areas
Sponsors
Leads: Allist Pharmaceuticals, Inc.