The Clinical Trial to Evaluate the Pharmacokinetics and Safety of MRTX849 in Patients With Advanced Solid Tumors

Advanced or Metastatic Solid Tumor Clinical Trial

Official title: A Phase 1, Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of MRTX849 in Chinese Patients With Advanced Solid Tumors With KRAS G12C Mutation

Status Active, not recruiting

Clinical Trial Summary

This is a phase 1, open-label, single-arm study in Chinese patients with unresectable, locally advanced or metastatic solid tumor with KRAS G12C mutation, for which treatment with curative intent is not available.

Patients must have a documented KRAS G12C mutation determined by tissue or liquid-based local testing.

The PK profile of MRTX849 in Chinese patients will be evaluated after administration of a single and repeat oral doses of 600 mg BID. In the PK lead-in period, blood samples will be collected pre-dose and up to 96 hours post a single oral dose of 600 mg MRTX849. Following this lead-in period, patients will start the dosing regimen of 600 mg BID orally, and blood samples will be collected pre-dose and up to 12 hours after multiple doses of MRTX849 600 mg BID on Cycle 1 Day 8 (C1D8).

Safety including AEs, ECGs, laboratory parameters and vital signs of each patient will be monitored throughout the conduct of the study.

Disease response and progression will be evaluated in accordance with Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumor
• Neoplasms

• NCT number: NCT05263986
• Study type: Interventional
• Source: Zai Lab (Hong Kong), Ltd.
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 30, 2022
• Completion date: October 31, 2023