NCT05634525

Phase Ib Trial of the KRASG12C Inhibitor Adagrasib (MRTX849) in KRAS G12C Mutant Metastatic Pancreatic Cancer Patients

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if the investigational study drug, adagrasib (also called MRTX849), can help to control pancreatic cancer that has a KRAS G12 mutation. The safety and possible effects of adagrasib will also be studied.

Detailed description

Primary Objectives: To assess the preliminary antitumor activity of Adagrasib (MRTX849) monotherapy in metastatic pancreatic cancer patients with KRAS G12C mutation using Objective Response Rate (ORR) = Complete response (CR)+Partial response (PR) by RECIST 1.1 criteria1. Secondary Objectives: To evaluate the safety, tolerability and antitumor activity of Adagrasib (MRTX849) monotherapy in metastatic pancreatic cancer patients with KRASG12C mutation including median overall survival (OS), progression free survival (PFS), safety and adverse events (AEs). Exploratory objectives: Exploratory objectives include identiying the genomic and nongenomic mechanisms to responses and resistance and the specific immune cells involved with outcome.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	MRTX849	Given By PO

Timeline

• Start date: 2023-05-03
• Primary completion: 2025-07-21
• Completion: 2025-07-21
• First posted: 2022-12-02
• Last updated: 2025-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study