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

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Atezolizumab: A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles.

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.

Bevacizumab: A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles.

Erlotinib: 150 mg of erlotinib will be administered PO QD in 21 day cycles.

GDC-1971: The starting dose of GDC-1971 will be determined from its single-agent dose escalation.

Inavolisib: The starting dose of inavolisib will be determined from its single-agent dose escalation.

Study 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.

Eligibility

Primary outcome measure(s)

• Percentage of Participants With Adverse Events (AEs) — From Cycle 1 Day 1 until 28 days after the final dose (or as specified in the protocol). A cycle is 21 days.
  Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
• Percentage of Participants With Dose-Limiting Toxicities (DLTs) — From Cycle 1 Day 1 through Day 21. A cycle is 21 days.

Trial sites (63)

+ 23 more sites — see the full list on the official registry below.

On this site

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