NCT05002270

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

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-21822 Monotherapy and Combination Therapy in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Jacobio Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 monotherapy to determine the MTD and PR2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 administered alone and combination with cetuximab during Dose Expansion phase in adult participants with advanced solid tumors harboring KRAS G12C mutation.

Conditions

• Advanced Solid Tumor
• NSCLC
• CRC

Interventions

Type	Name	Description
DRUG	JAB-21822 (KRAS G12C inhibitor)	Administered orally
DRUG	JAB-21822 (KRAS G12C inhibitor)	Administered orally
DRUG	JAB-21822 (KRAS G12C inhibitor)	Administered orally
DRUG	Cetuximab (EGFR inhibitor)	Administered IV

Timeline

• Start date: 2021-09-03
• Primary completion: 2025-02-12
• Completion: 2025-02-12
• First posted: 2021-08-12
• Last updated: 2026-01-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study