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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
18 years of age
Both
Phase 1

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Overview

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

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

Study details

Solid Tumor

NCT06619587

Genentech, Inc.

16 May 2025

Step 1 Get in touch with the nearest study center
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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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