NCT05288205

Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation

A Phase 1/2a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JAB-21822 in Combination With JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Allist Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label phase 1/2a study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of JAB-21822 in combination with JAB-3312 in patients with advanced solid tumors harboring KRAS p.G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion phase, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.

Conditions

• KRAS P.G12C
• Non-small Cell Lung Cancer
• Colorectal Cancer
• Pancreatic Ductal Carcinoma

Interventions

Type	Name	Description
DRUG	JAB-21822	KRAS G12C inhibitor
DRUG	JAB-3312	SHP2 inhibitor

Timeline

• Start date: 2022-04-14
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2022-03-21
• Last updated: 2025-04-04

Locations

27 sites across 1 country: China