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

August 27, 2026 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

498

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • New South Wales
      • Mount Kuring-Gai, New South Wales, Australia, 2080
        • Slade Health Inward goods
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Health
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Center
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Clinical Research Limited
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Liège, Belgium, 4000
        • CHU de Liege
      • Mechelen, Belgium, 2800
        • AZ St Maarten Campus Leopoldstr
      • Rio de Janeiro, Brazil, 20230-130
        • Instituto Nacional de Cancer
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Santa Casa de Misericordia de Belo Horizonte - PPDS
    • Paraná
      • Curitiba, Paraná, Brazil, 81520-060
        • Hospital Erasto Gaertner
    • Pará
      • Porto Alegre, Pará, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre HCPA PPDS
    • Rio Grande do Sul
      • Caxias do Sul, Rio Grande do Sul, Brazil, 95070-561
        • Universidade de Caxias do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Gyöngyös, Hungary, 3200
        • Clinexpert Gyongyos Kft
      • Haifa, Israel, 3109601
        • Rambam Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel-Aviv Sourasky Medical Center
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milan, Lombardy, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda
      • Rozzano (MI), Lombardy, Italy, 20089
        • Istituto Clinico Humanitas
    • Tuscany
      • Pisa, Tuscany, Italy, 56100
        • Azienda Ospedaliero Universitaria Pisana
      • Nairobi, Kenya, 00100
        • The Aga Khan University-Kenya.
      • Amsterdam, Netherlands, 1066 CX
        • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
      • Leiden, Netherlands, 2333 ZA
        • Leids Universitair Medisch Centrum
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Center
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht
      • Auckland, New Zealand
        • Auckland City Hospital
      • Auckland, New Zealand, 1023
        • Auckland City Hospital, Cancer and Blood Research
      • Christchurch, New Zealand
        • New Zealand Clinical Research - Christchurch
      • Bergen, Norway, 5020
        • Haukeland University Hospital
      • Oslo, Norway, 0424
        • Oslo university hospital Radiumhospitalet
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz
      • Józefów, Poland, 05-410
        • Biokinetica, Przychodnia Jozefow
      • Seongnam-si, South Korea, 13605
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center - PPDS
      • Seoul, South Korea, 06351
        • Samsung Medical Center - PPDS
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28040
        • START Madrid-FJD, Hospital Fundación Jiménez Díaz
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro-CIOCC
      • Málaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Bern, Switzerland, 3010
        • Inselspital
      • Geneva, Switzerland, 1211
        • Hôpitaux Universitaires de Genève
      • Birmingham, United Kingdom, B15 2GW
        • Queen Elizabeth Hospital
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre Cancer Centre
      • London, United Kingdom, W1T 7HA
        • NIHR UCLH Clinical Research Facility
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
    • California
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • La Jolla, California, United States, 92093
        • UCSD Moores Cancer Center
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center UCI
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale Cancer Center
    • Florida
      • Sarasota, Florida, United States, 34232
        • Florida Cancer Specialists - Sarasota
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC - Hillman Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.
  • Women of childbearing potential must agree to remain abstinent or use contraception, and agree to refrain from donating eggs during the treatment period and after the final dose of study treatment as specified in the protocol.
  • Men who are not surgically sterile must agree to remain abstinent or use a condom, and agreement to refrain from donating sperm during the treatment period and after the final dose of study treatment as specified in the protocol.

Exclusion Criteria:

  • Active brain metastases.
  • Malabsorption or other condition that interferes with enteral absorption.
  • Clinically significant cardiovascular dysfunction or liver disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

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).
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.
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).
A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles.
Experimental: Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)
Participants with colorectal cancer will receive GDC-6036 in combination with cetuximab.
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).
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.
Experimental: Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)
Participants with solid tumors will receive GDC-6036 in combination with bevacizumab.
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).
A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles.
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.
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).
150 mg of erlotinib will be administered PO QD in 21 day cycles.
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.

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

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma Concentrations of GDC-6036
Time Frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Plasma Concentrations of Erlotinib
Time Frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Plasma Concentrations of GDC-1971
Time Frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Plasma Concentrations of Inavolisib
Time Frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time Frame: Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
Time Frame: Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Progression-free survival (PFS) as determined by the investigator according to RECIST v1.1
Time Frame: Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Relationship Between GDC-6036 Exposure (Maximum Plasma Concentration Observed [Cmax])
Time Frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Relationship Between GDC-6036 Exposure (Time to Maximum Plasma Concentration [Tmax])
Time Frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Relationship Between GDC-6036 Exposure (Half-life [t1/2])
Time Frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Relationship Between GDC-6036 Exposure (Area Under the Curve [AUC])
Time Frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Relationship Between Tumor Pharmacodynamic Effects of GDC-6036
Time Frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Clinical Trials, Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2020

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 24, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 29, 2020

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • GO42144
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2020-000084-22 (EudraCT Number)
  • 2023-506311-18-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.