NCT05263986

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

Status unknown Phase 1 Last updated 27 February 2023

What this trial tests

Phase 1 trial testing MRTX849 in Advanced or Metastatic Solid Tumor in 22 participants. Status unknown.

Timeline

30 May 2022

Primary endpoint
31 October 2023

31 October 2023

Quick facts

Lead sponsor	Zai Lab (Shanghai) Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	30 May 2022
Primary completion	31 October 2023
Estimated completion	31 October 2023
Sites	8 locations across China

Drugs / interventions tested

• MRTX849 — full drug profile →

Conditions studied

• Advanced or Metastatic Solid Tumor — all drugs for Advanced or Metastatic Solid Tumor →

Sponsor

Zai Lab (Shanghai) Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Advanced or Metastatic Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The current state of the art and future trends in RAS-targeted cancer therapies.
   Punekar SR, Velcheti V, Neel BG, Wong KK. · · 2022 · cited 382× · PMID 36028717 · DOI 10.1038/s41571-022-00671-9
2. Targeting small GTPases: emerging grasps on previously untamable targets, pioneered by KRAS.
   Yin G, Huang J, Petela J, Jiang H, et al · · 2023 · cited 50× · PMID 37221195 · DOI 10.1038/s41392-023-01441-4
3. MYC and KRAS cooperation: from historical challenges to therapeutic opportunities in cancer.
   Casacuberta-Serra S, González-Larreategui Í, Capitán-Leo D, Soucek L. · · 2024 · cited 43× · PMID 39164274 · DOI 10.1038/s41392-024-01907-z
4. KRAS: A Druggable Target in Colon Cancer Patients.
   Negri F, Bottarelli L, de'Angelis GL, Gnetti L. · · 2022 · cited 36× · PMID 35456940 · DOI 10.3390/ijms23084120
5. Targeting KRAS mutations in pancreatic cancer: opportunities for future strategies.
   Linehan A, O'Reilly M, McDermott R, O'Kane GM. · · 2024 · cited 24× · PMID 38576709 · DOI 10.3389/fmed.2024.1369136
6. Emerging Pharmacotherapeutic Strategies to Overcome Undruggable Proteins in Cancer.
   Lu Y, Yang Y, Zhu G, Zeng H, et al · · 2023 · cited 24× · PMID 37496997 · DOI 10.7150/ijbs.83026
7. Direct GDP-KRAS^G12C inhibitors and mechanisms of resistance: the tip of the iceberg.
   Rosen JC, Sacher A, Tsao MS. · · 2023 · cited 15× · PMID 36950276 · DOI 10.1177/17588359231160141
8. A Long Overdue Targeted Treatment for KRAS Mutations in NSCLC: Spotlight on Adagrasib.
   Brazel D, Arter Z, Nagasaka M. · · 2022 · cited 9× · PMID 36387582 · DOI 10.2147/lctt.s383662