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

Genentech

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor

Treatments: Drug: Phase I Arm B; Drug: Phase I Arm A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06619587

GO45416

Details and patient eligibility

About

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.

Enrollment: 410 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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410 participants in 2 patient groups

Phase I Arm A

Experimental group

Description:

Dose escalation and expansion arm

Treatment:

Drug: Phase I Arm A

Phase I Arm B

Experimental group

Description:

Dose escalation and expansion arm

Treatment:

Drug: Phase I Arm B