Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Description

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Conditions

Advanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation

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Study Overview

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Study Details

Study overview

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Condition
Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Tucson

Arizona Oncology Associates Professional Corporation, Tucson, Arizona, United States, 85711

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

La Jolla

University of California San Diego Moores Cancer Center, La Jolla, California, United States, 92093

Loma Linda

Loma Linda University Cancer Center, Loma Linda, California, United States, 92354

Los Angeles

University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033

Sacramento

University of California Davis Medical Center, Sacramento, California, United States, 95817

San Francisco

University of California San Francisco Mission Bay Campus, San Francisco, California, United States, 94115

Santa Monica

University of California Los Angeles, Santa Monica, California, United States, 90404

Denver

Rocky Mountain Cancer Centers Denver Midtown, Denver, Colorado, United States, 80218

Denver

Sarah Cannon Research Institute, Denver, Colorado, United States, 80218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Men or women greater than or equal to 18 years old.
  • * Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
  • * Primary brain tumor.
  • * Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
  • * Myocardial infarction within 6 months of study day 1.
  • * Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2028-03-13