NCT05263986

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

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Zai Lab (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Advanced or Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	MRTX849	Approximately 18-24 patients to ensure at least 12 PK evaluable patients. Subjects will be administered a single oral dose of 600 mg MRTX849 in PK lead in D1, and will start the dosing regimen of 600 mg BID orally from C1D1.

Timeline

• Start date: 2022-05-30
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2022-03-03
• Last updated: 2023-02-27

Locations

8 sites across 1 country: China