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Purpose

This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation - Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm

Exclusion Criteria

  • Malabsorption or other condition that would interfere with enteral absorption - Active brain metastases - Clinically significant cardiovascular dysfunction or liver disease

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase I Arm A 		Dose escalation and expansion arm
  • Drug: Phase I Arm A
    Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035
Experimental
Phase I Arm B 		Dose escalation and expansion arm
  • Drug: Phase I Arm B
    Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies

Recruiting Locations

UC San Diego Moores Cancer Center
La Jolla, California 92093-1503

Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218

Yale Cancer Center
New Haven, Connecticut 06510

University of Illinois
Chicago, Illinois 60612

Dana Farber Cancer Institute
Boston, Massachusetts 02215

START - Midwest - EDOS
Grand Rapids, Michigan 49546-7062

Montefiore Einstein Cancer Center
The Bronx, New York 10461

Mary Crowley Medical Research Center
Dallas, Pennsylvania 75230-2571

Abramson Cancer Center;Univ of Pennsylvania
Philadelphia, Pennsylvania 19104-5127

SCRI Oncology Partners
Nashville, Tennessee 37203

More Details

Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

Reference Study ID Number: GO45416 https://forpatients.roche.com/
888-662-6728 (U.S.)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.