A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

Description

This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.

Conditions

Non-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumors

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Study Overview

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Study Details

Study overview

This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.

A Phase Ia/Ib Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 as a Single Agent and in Combination With Other Anti-cancer Therapies in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

Condition
Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope Comprehensive Cancer Center, Duarte, California, United States, 91010

La Jolla

UCSD Moores Cancer Center, La Jolla, California, United States, 92093

Orange

Chao Family Comprehensive Cancer Center UCI, Orange, California, United States, 92868

San Francisco

Univ of Calif, San Francisco; Breast Cancer Center, San Francisco, California, United States, 94115

New Haven

Yale Cancer Center, New Haven, Connecticut, United States, 06520

Sarasota

Florida Cancer Specialists - Sarasota, Sarasota, Florida, United States, 34232

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 11101

Oklahoma City

University of Oklahoma; Stephenson Oklahoma Canc Ctr, Oklahoma City, Oklahoma, United States, 73104

Philadelphia

Abramson Cancer Center; Univ of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

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

  • * Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.
  • * Women of childbearing potential must agree to remain abstinent or use contraception, and agree to refrain from donating eggs during the treatment period and after the final dose of study treatment as specified in the protocol.
  • * Men who are not surgically sterile must agree to remain abstinent or use a condom, and agreement to refrain from donating sperm during the treatment period and after the final dose of study treatment as specified in the protocol.
  • * Active brain metastases.
  • * Malabsorption or other condition that interferes with enteral absorption.
  • * Clinically significant cardiovascular dysfunction or liver disease.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Genentech, Inc.,

Clinical Trials, STUDY_DIRECTOR, Genentech, Inc.

Study Record Dates

2024-11-30