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Study of GDC-7035 for Advanced Solid Tumors with KRAS G12D Mutation

This study is testing a new drug called GDC-7035, alone and with other cancer treatments, for people with advanced solid tumors that have a specific genetic change called KRAS G12D. Researchers want to see how safe GDC-7035 is and how your body handles it. They will also look for early signs that the drug is working. To join, you must have an advanced or metastatic (spread) solid tumor with the KRAS G12D mutation and be at least 18 years old. The main goals are to track side effects and dose-limiting toxicities (side effects that are severe enough to stop treatment). This study is currently unclear on its recruitment status and plans to enroll 410 participants.

Study design
This is a Phase I/II, open-label (meaning both you and your doctor will know what treatment you are receiving), multicenter study. It involves increasing doses of GDC-7035 to find the safest and most effective amount.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events and dose-limiting toxicities for up to 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Genentech, Inc.
~410 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Phase I Arm APhase I Arm B

At a glance

Recruiting sites
40 of 41 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale
Measured over 4 Years
+1 more outcome measured

Conditions

Solid Tumor

Explore related trials

Solid NeoplasmGTPase KRas

Where it's being run

41 sites across 24 states
Spain6
Israel4
South Korea4
United Kingdom3
Pennsylvania2
New South Wales2
France2
Singapore2

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: GO45416 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S.)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale4 Years
  • Percentage of Participants with Dose Limiting Toxicity4 Years