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New drug targets Hard-to-Treat cancer mutation in early trial

NCT ID NCT06619587

Disease control Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 26, 2026 · Updated 7 times

Summary

This study tests a new drug called GDC-7035, designed to target cancers with a specific genetic change called KRAS G12D. The trial includes about 410 adults with advanced solid tumors that have not responded to other treatments. Researchers will give the drug alone or with other cancer therapies to check its safety and how well it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GDC-7035 (a drug targeting the KRAS G12D mutation)
What this could lead to
If successful, this could lead to a new targeted treatment option for people with advanced solid tumors that have a specific KRAS G12D mutation.
What could go wrong
This is a very early (first-in-human) study, so safety and effectiveness are not yet known. Many early-stage cancer drugs do not end up working in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 410 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    41 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abramson Cancer Center;Univ of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104-5127, United States

  • Asan Medical Center.

    RECRUITING

    Seoul, 005505, South Korea

  • British Columbia Cancer Agency

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Centre Georges Francois Leclerc

    RECRUITING

    Dijon, 21000, France

  • Centro Richerche Cliniche di Verona

    RECRUITING

    Verona, Veneto, 37134, Italy

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialist-Lake Mary

    COMPLETED

    Lake Mary, Florida, 32746, United States

  • Gustave Roussy

    RECRUITING

    Villejuif, Val-de-Marne, 94805, France

  • Hadassah University Hospital - Ein Kerem

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario Virgen del Rocio - PPDS

    RECRUITING

    Seville, 41013, Spain

  • Institut Bergonie

    RECRUITING

    Bordeaux, 33076, France

  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

    RECRUITING

    Barcelona, 08035, Spain

  • Mary Crowley Medical Research Center

    RECRUITING

    Dallas, Pennsylvania, 75230-2571, United States

  • Montefiore Einstein Cancer Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • NIHR UCLH Clinical Research Facility

    RECRUITING

    London, W1T 7HA, United Kingdom

  • National Cancer Centre

    RECRUITING

    Singapore, 168583, Singapore

  • National University Hospital

    RECRUITING

    Singapore, 119074, Singapore

  • O'Quinn Medical Tower at McNair Campus

    RECRUITING

    Houston, Texas, 77054, United States

  • Peter Maccallum Cancer Centre

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 1X6, Canada

  • Rambam Health Care Campus

    RECRUITING

    Haifa, 3109601, Israel

  • Royal Marsden Hospital - Surrey

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • START - Midwest - EDOS

    RECRUITING

    Grand Rapids, Michigan, 49546-7062, United States

  • START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

    RECRUITING

    Madrid, 28050, Spain

  • Sarah Cannon Research Institute at HealthONE

    RECRUITING

    Denver, Colorado, 80218, United States

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 3722, South Korea

  • Sir Mortimer B Davis Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Slade Health Inward goods

    RECRUITING

    Mount Kuring-Gai, New South Wales, 2080, Australia

  • St Vincent's Hospital Sydney

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • Tel Aviv Sourasky Medical Center PPDS

    RECRUITING

    Tel Aviv, 6423906, Israel

  • The Chaim Sheba Medical Center

    RECRUITING

    Ramat Gan, 5262100, Israel

  • The Christie

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • UC San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093-1503, United States

  • University of Illinois

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Western General Hospital;Edinburgh Cancer Center

    RECRUITING

    Edinburgh, Midlothian, EH4 2LF, United Kingdom

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.