Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06619587

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

Led by Genentech, Inc. · Updated on 2026-05-04

410

Participants Needed

38

Research Sites

184 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
  • Agreement to adhere to contraception requirements for participants of childbearing potential and those who produce sperm
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 38 locations

1

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92093-1503

Actively Recruiting

2

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States, 80218

Actively Recruiting

3

Yale Cancer Center

New Haven, Connecticut, United States, 06510

Actively Recruiting

4

Florida Cancer Specialist-Lake Mary

Lake Mary, Florida, United States, 32746

Completed

5

University of Illinois

Chicago, Illinois, United States, 60612

Actively Recruiting

6

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

7

START - Midwest - EDOS

Grand Rapids, Michigan, United States, 49546-7062

Actively Recruiting

8

Montefiore Einstein Cancer Center

The Bronx, New York, United States, 10461

Actively Recruiting

9

Mary Crowley Medical Research Center

Dallas, Pennsylvania, United States, 75230-2571

Actively Recruiting

10

Abramson Cancer Center;Univ of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104-5127

Actively Recruiting

11

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

Actively Recruiting

12

O'Quinn Medical Tower at McNair Campus

Houston, Texas, United States, 77054

Actively Recruiting

13

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia, 2010

Actively Recruiting

14

Peter Maccallum Cancer Centre

Parkville, Victoria, Australia, 3052

Actively Recruiting

15

British Columbia Cancer Agency

Vancouver, British Columbia, Canada, V5Z 4E6

Actively Recruiting

16

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 1X6

Actively Recruiting

17

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Actively Recruiting

18

Institut Bergonie

Bordeaux, France, 33076

Actively Recruiting

19

Rambam Health Care Campus

Haifa, Israel, 3109601

Actively Recruiting

20

Hadassah University Hospital - Ein Kerem

Jerusalem, Israel, 9112001

Actively Recruiting

21

The Chaim Sheba Medical Center

Ramat Gan, Israel, 5262100

Actively Recruiting

22

Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, Israel, 6423906

Actively Recruiting

23

National University Hospital

Singapore, Singapore, 119074

Actively Recruiting

24

National Cancer Centre

Singapore, Singapore, 168583

Actively Recruiting

25

Seoul National University Bundang Hospital

Seongnam, South Korea, 13620

Actively Recruiting

26

Asan Medical Center.

Seoul, South Korea, 005505

Actively Recruiting

27

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

28

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 3722

Actively Recruiting

29

Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

Barcelona, Spain, 08035

Actively Recruiting

30

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Actively Recruiting

31

START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

Madrid, Spain, 28050

Actively Recruiting

32

Hospital Universitario Virgen de la Victoria

Málaga, Spain, 29010

Actively Recruiting

33

Hospital Universitario Virgen del Rocio - PPDS

Seville, Spain, 41013

Actively Recruiting

34

Hospital Clinico Universitario de Valencia

Valencia, Spain, 46010

Actively Recruiting

35

Western General Hospital;Edinburgh Cancer Center

Edinburgh, Midlothian, United Kingdom, EH4 2LF

Actively Recruiting

36

NIHR UCLH Clinical Research Facility

London, United Kingdom, W1T 7HA

Actively Recruiting

37

The Christie

Manchester, United Kingdom, M20 4BX

Actively Recruiting

38

Royal Marsden Hospital - Surrey

Sutton, United Kingdom, SM2 5PT

Actively Recruiting

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Research Team

R

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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