JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the safety and tolerability of JAB-21822 monotherapy and combination therapy in adult participants with advanced solid tumors harboring KRAS 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 solid tumors with KRAS 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 or spinal metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days

• Active infection requiring systemic treatment within 7 days

• Active HBV or HCV

• Any severe and/or uncontrolled medical conditions

• LVEF ≤50% assessed by ECHO or QTcF

• QT interval >470 msec

• Experiencing unresolved CTCAE 5.0 Grade >1 toxicities