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Brief Title: Phase Ib Trial of the KRASG12C Inhibitor Adagrasib (MRTX849) in KRAS G12C Mutant Metastatic Pancreatic Cancer Patients
Official Title: Phase Ib Trial of the KRASG12C Inhibitor Adagrasib (MRTX849) in KRAS G12C Mutant Metastatic Pancreatic Cancer Patients
Study ID: NCT05634525
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
M D Anderson Cancer Center, Houston, Texas, United States
Name: Dan Zhao, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR