NCT04449874

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

A Phase Ia/Ib Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 as a Single Agent and in Combination With Other Anti-cancer Therapies in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 498 (estimated)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.

Conditions

• Non-Small Cell Lung Cancer
• Colorectal Cancer
• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	GDC-6036	The starting dose of GDC-6036 in the combination Arms B, C, D, E, F and G will be determined from Stage I Arm A (single-agent dose escalation).
DRUG	Atezolizumab	A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles.
DRUG	Cetuximab	Cetuximab will be administered at an initial dose of 400 milligram per square meter (mg/m\^2) IV infusion followed by 250 mg/m\^2 IV infusion weekly in 21 day cycles.
DRUG	Bevacizumab	A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles.
DRUG	Erlotinib	150 mg of erlotinib will be administered PO QD in 21 day cycles.
DRUG	GDC-1971	The starting dose of GDC-1971 will be determined from its single-agent dose escalation.
DRUG	Inavolisib	The starting dose of inavolisib will be determined from its single-agent dose escalation.

Timeline

• Start date: 2020-07-29
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2020-06-29
• Last updated: 2026-02-12

Locations

63 sites across 17 countries: United States, Australia, Belgium, Brazil, Canada, Hungary, Israel, Italy, Kenya, Netherlands, New Zealand, Norway, Poland, South Korea, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study