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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• GDC-6036 — DRUG
  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 — DRUG
  A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles.
• Cetuximab — DRUG
  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 — DRUG
  A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles.
• Erlotinib — DRUG
  150 mg of erlotinib will be administered PO QD in 21 day cycles.
• GDC-1971 — DRUG
  The starting dose of GDC-1971 will be determined from its single-agent dose escalation.
• Inavolisib — DRUG
  The starting dose of inavolisib will be determined from its single-agent dose escalation.

Study Details

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.

Key Dates

Start date

Jul 29, 2020

Status verified

Jun 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

498 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II)
  Participants in Stage I will receive GDC-6036 administered orally once daily (PO QD). The dose will be increased in successive cohorts until a study-specific threshold is reached. Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II.
• Experimental: Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)
  Participants with non-small cell lung cancer will receive GDC-6036 in combination with atezolizumab.
• Experimental: Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)
  Participants with colorectal cancer will receive GDC-6036 in combination with cetuximab.
• Experimental: Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)
  Participants with solid tumors will receive GDC-6036 in combination with bevacizumab.
• Experimental: Arm E: GDC-6036 + Erlotinib (Stage I and Stage II)
  Participants with non-small cell lung cancer will receive GDC-6036 in combination with erlotinib.
• Experimental: Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II)
  Participants with solid tumors will receive GDC-6036 in combination with GDC-1971 PO in Stage I. Participants with select solid tumors will be treated with GDC-6036 in combination with GDC-1971 PO in Stage II.
• Experimental: Arm G: GDC-6036 + Inavolisib (Stage I and Stage II)
  Participants with solid tumors will receive GDC-6036 in combination with inavolisib PO in Stage I. Participants with select solid tumors will be treated with GDC-6036 in combination with inavolisib PO in Stage II.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) [ Time Frame: From Cycle 1 Day 1 until 28 days after the final dose (or as specified in the protocol). A cycle is 21 days. ]

Locations (8)

Find similar trials in Duarte, CA

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