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

Phase 1

Recruiting

• Conditions: Solid Tumor
• Interventions: Drug: Phase I Arm A; Drug: Phase I Arm B

• Registration Number: NCT06619587
• Lead Sponsor: Genentech, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-09-27
• Study First Posted: 2024-10-01
• Study Start: 2024-11-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2028-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 410

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase I Arm A	Phase I Arm A	Dose escalation and expansion arm
Phase I Arm B	Phase I Arm B	Dose escalation and expansion arm

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale	4 Years
Percentage of Participants with Dose Limiting Toxicity	4 Years

Secondary Outcome Measures

Name	Time	Method
Plasma Concentrations of GDC-7035 at Specified Timepoints	4 Years
Blood Concentrations of GDC-7035 at Specified Timepoints	4 Years
Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal	4 Years
Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal	4 Years
Objective Response Rate Among Participants	4 Years
Duration of Response Among Participants	4 Years
Median Progression Free Survival Time Among Participants	4 Years

Trial Locations

Locations (3)

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

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

Peter Maccallum Cancer Centre; 🇦🇺 Parkville, Victoria, Australia