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NCT Number: 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

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.

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phase I Arm A

Drug

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

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

Primary outcomes

  1. Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale

    Time frame: 4 Years

  2. Percentage of Participants with Dose Limiting Toxicity

    Time frame: 4 Years

Secondary outcomes

  1. Plasma Concentrations of GDC-7035 at Specified Timepoints

    Time frame: 4 Years

  2. Blood Concentrations of GDC-7035 at Specified Timepoints

    Time frame: 4 Years

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

    Time frame: 4 Years

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

    Time frame: 4 Years

  5. Objective Response Rate Among Participants

    Time frame: 4 Years

  6. Duration of Response Among Participants

    Time frame: 4 Years

  7. Median Progression Free Survival Time Among Participants

    Time frame: 4 Years

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: GO45416 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S.)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase I/II Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 1, 2024
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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