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A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors

RECRUITINGPhase 1Sponsored by Genentech, Inc.
Actively Recruiting
PhasePhase 1
SponsorGenentech, Inc.
Started2024-11-14
Est. completion2028-05-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations12 sites
View on ClinicalTrials.gov →

NCT06619587

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerSolid Tumor

Interventions2

Phase I Arm APhase I Arm B

Locations12 sites

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
Florida Cancer Specialist-Lake Mary
Lake Mary, Florida, 32746
University of Illinois
Chicago, Illinois, 60612

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