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

NCT06619587 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Genentech, Inc

Phase

Phase 1

Started

2024-11-14

Last updated

2026-09-23

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

Phase I Arm APhase I Arm B

Phase I Arm A: Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035

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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale — 4 Years
Percentage of Participants with Dose Limiting Toxicity — 4 Years

Trial sites (43)

Facility	City	Region	Status
UC San Diego Moores Cancer Center	La Jolla	California	Recruiting
Sarah Cannon Research Institute at HealthONE	Denver	Colorado	Recruiting
Yale Cancer Center	New Haven	Connecticut	Recruiting
Florida Cancer Specialist-Lake Mary	Lake Mary	Florida	Completed
University of Illinois	Chicago	Illinois	Recruiting
Dana Farber Cancer Institute	Boston	Massachusetts	Recruiting
START - Midwest - EDOS	Grand Rapids	Michigan	Recruiting
Montefiore Einstein Cancer Center	The Bronx	New York	Recruiting
Mary Crowley Medical Research Center	Dallas	Pennsylvania	Recruiting
Abramson Cancer Center;Univ of Pennsylvania	Philadelphia	Pennsylvania	Recruiting
SCRI Oncology Partners	Nashville	Tennessee	Recruiting
O'Quinn Medical Tower at McNair Campus	Houston	Texas	Recruiting
St Vincent's Hospital Sydney	Darlinghurst	New South Wales	Recruiting
Slade Health Inward goods	Mount Kuring-Gai	New South Wales	Recruiting
Peter Maccallum Cancer Centre	Parkville	Victoria	Recruiting
British Columbia Cancer Agency	Vancouver	British Columbia	Recruiting
Princess Margaret Cancer Centre	Toronto	Ontario	Recruiting
Sir Mortimer B Davis Jewish General Hospital	Montreal	Quebec	Recruiting
Gustave Roussy	Villejuif	Val-de-Marne	Recruiting
Institut Bergonie	Bordeaux	France	Recruiting
Centre Georges Francois Leclerc	Dijon	France	Recruiting
Rambam Health Care Campus	Haifa	Israel	Recruiting
Hadassah University Hospital - Ein Kerem	Jerusalem	Israel	Recruiting
The Chaim Sheba Medical Center	Ramat Gan	Israel	Recruiting
Tel Aviv Sourasky Medical Center PPDS	Tel Aviv	Israel	Recruiting
Centro Richerche Cliniche di Verona	Verona	Veneto	Recruiting
Universitair Medisch Centrum Groningen	Groningen	Netherlands	Recruiting
National University Hospital	Singapore	Singapore	Recruiting
National Cancer Centre	Singapore	Singapore	Recruiting
Seoul National University Bundang Hospital	Seongnam	South Korea	Recruiting
Asan Medical Center.	Seoul	South Korea	Recruiting
Seoul National University Hospital	Seoul	South Korea	Recruiting
Severance Hospital, Yonsei University Health System	Seoul	South Korea	Recruiting
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON	Barcelona	Spain	Recruiting
Hospital Universitario 12 de Octubre	Madrid	Spain	Recruiting
START Madrid_Hospital Universitario HM Sanchinarro_CIOCC	Madrid	Spain	Recruiting
Hospital Universitario Virgen de la Victoria	Málaga	Spain	Recruiting
Hospital Universitario Virgen del Rocio - PPDS	Seville	Spain	Recruiting
Hospital Clinico Universitario de Valencia	Valencia	Spain	Recruiting
Western General Hospital;Edinburgh Cancer Center	Edinburgh	Midlothian	Recruiting

+ 3 more sites — see the full list on the official registry below.

More Genentech, Inc. trials in the Netherlands

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors Active, not recruiting

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A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC Active, not recruiting

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 Active, not recruiting

Other trials for the same condition

An Extension Study for Patients Previously Enrolled in Studies With Pelabresib Recruiting

PET-imaging of Two Vartumabs in Patients With Solid Tumors Recruiting

Feasibility of Switching Fluoropyrimidine Due to Cardiotoxicity Study Enrolling by invitation

A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors Active, not recruiting

A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06619587 on ClinicalTrials.gov ↗ ← All trials in the Netherlands