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 | Recruiting Phase 1 FDA Drug

• 1 other identifier: GO45416
• Study Type: interventional
• Target: 410
• Locations: 9 countries
• Sites: 38

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Plasma Concentrations of GDC-7035 at Specified Timepoints

  4 Years

• Blood Concentrations of GDC-7035 at Specified Timepoints

  4 Years

• Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal

  4 Years

• Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal

  4 Years

• Objective Response Rate Among Participants

  4 Years

Study Arms (2)

Phase I Arm A

EXPERIMENTAL

Dose escalation and expansion arm

Drug: Phase I Arm A

Phase I Arm B

EXPERIMENTAL

Dose escalation and expansion arm

Drug: Phase I Arm B

Interventions

Phase I Arm B DRUG

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

Phase I Arm B

Phase I Arm A DRUG

Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035

Phase I Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (38)

UC San Diego Moores Cancer Center

La Jolla, California, 92093-1503, United States

RECRUITING

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06510, United States

RECRUITING

Florida Cancer Specialist-Lake Mary

Lake Mary, Florida, 32746, United States

COMPLETED

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

START - Midwest - EDOS

Grand Rapids, Michigan, 49546-7062, United States

RECRUITING

Montefiore Einstein Cancer Center

The Bronx, New York, 10461, United States

RECRUITING

Mary Crowley Medical Research Center

Dallas, Pennsylvania, 75230-2571, United States

RECRUITING

Abramson Cancer Center;Univ of Pennsylvania

Philadelphia, Pennsylvania, 19104-5127, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

O'Quinn Medical Tower at McNair Campus

Houston, Texas, 77054, United States

RECRUITING

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Peter Maccallum Cancer Centre

Parkville, Victoria, 3052, Australia

RECRUITING

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1X6, Canada

RECRUITING

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Institut Bergonie

Bordeaux, 33076, France

RECRUITING

Rambam Health Care Campus

Haifa, 3109601, Israel

RECRUITING

Hadassah University Hospital - Ein Kerem

Jerusalem, 9112001, Israel

RECRUITING

The Chaim Sheba Medical Center

Ramat Gan, 5262100, Israel

RECRUITING

Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, 6423906, Israel

RECRUITING

National University Hospital

Singapore, 119074, Singapore

RECRUITING

National Cancer Centre

Singapore, 168583, Singapore

RECRUITING

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

RECRUITING

Asan Medical Center.

Seoul, 005505, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 3722, South Korea

RECRUITING

Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

Madrid, 28050, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Western General Hospital;Edinburgh Cancer Center

Edinburgh, Midlothian, EH4 2LF, United Kingdom

RECRUITING

NIHR UCLH Clinical Research Facility

London, W1T 7HA, United Kingdom

RECRUITING

The Christie

Manchester, M20 4BX, United Kingdom

RECRUITING

Royal Marsden Hospital - Surrey

Sutton, SM2 5PT, United Kingdom

RECRUITING

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GO45416 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S.); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); GB (4); FR (1); ES (6); KR (4); SG (2); CA (3); IL (4); US (12)