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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Phase I Arm A	Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035
DRUG	Phase I Arm B	Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies

Timeline

• Start date: 2024-11-14
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2024-10-01
• Last updated: 2026-04-03

Locations

36 sites across 8 countries: United States, Australia, Canada, Israel, Singapore, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study