RecruitingPhase 1Phase 2NCT05288205

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

Sponsor

Allist Pharmaceuticals, Inc.

Enrollment

240 participants

Start Date

Apr 14, 2022

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer KRAS P.G12C

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two experimental drugs (JAB-21822 and JAB-3312) in people with advanced solid tumors that have a specific genetic change called a KRAS G12C mutation. This mutation is found in some lung, colon, and other cancers, and these drugs are designed to target it. **You may be eligible if...** - You are 18 or older - Your cancer has been confirmed by a biopsy to have the KRAS G12C mutation - Your cancer is locally advanced or has spread and has not responded to standard treatments, or standard treatments are unavailable - You have at least one measurable tumor on imaging - You are in reasonably good general health - Your expected survival is at least 3 months **You may NOT be eligible if...** - Your tumor does not have the KRAS G12C mutation - Your general health is too poor to participate - You have active brain metastases that are unstable or untreated - You have significant heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGJAB-21822

KRAS G12C inhibitor

DRUGJAB-3312

SHP2 inhibitor