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
NCT ID: NCT04449874
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
498 participants
INTERVENTIONAL
2020-07-29
2026-09-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
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).
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.
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.
Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)
Participants with colorectal cancer will receive GDC-6036 in combination with cetuximab.
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).
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.
Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)
Participants with solid tumors will receive GDC-6036 in combination with bevacizumab.
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).
Bevacizumab
A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles.
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.
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).
Erlotinib
150 mg of erlotinib will be administered PO QD in 21 day cycles.
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.
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).
GDC-1971
The starting dose of GDC-1971 will be determined from its single-agent dose escalation.
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.
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).
Inavolisib
The starting dose of inavolisib will be determined from its single-agent dose escalation.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Malabsorption or other condition that interferes with enteral absorption.
* Clinically significant cardiovascular dysfunction or liver disease.
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
UCSD Moores Cancer Center
La Jolla, California, United States
Chao Family Comprehensive Cancer Center UCI
Orange, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Abramson Cancer Center
Philadelphia, Pennsylvania, United States
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Slade Health Inward goods
Mount Kuring-Gai, New South Wales, Australia
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
Linear Clinical Research Limited
Nedlands, Western Australia, Australia
UZ Antwerpen
Edegem, , Belgium
CHU de Liège
Liège, , Belgium
AZ St Maarten Campus Leopoldstr
Mechelen, , Belgium
Santa Casa de Misericordia de Belo Horizonte - PPDS
Belo Horizonte, Minas Gerais, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre HCPA PPDS
Pôrto Alegre, Pará, Brazil
Universidade de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto, São Paulo, Brazil
Instituto Nacional de Câncer
Rio de Janeiro, , Brazil
Ottawa Hospital
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Clinexpert Gyongyos Kft
Gyöngyös, , Hungary
Rambam Medical Center
Haifa, , Israel
Sheba Medical Center - PPDS
Ramat Gan, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Meldola, Emilia-Romagna, Italy
Irccs Ospedale San Raffaele
Milan, Lombardy, Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
The Aga Khan University-Kenya.
Nairobi, , Kenya
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Auckland City Hospital, Cancer and Blood Research
Auckland, , New Zealand
Auckland City Hospital
Auckland, , New Zealand
New Zealand Clinical Research - Christchurch
Christchurch, , New Zealand
Haukeland University Hospital
Bergen, , Norway
Oslo university hospital Radiumhospitalet
Oslo, , Norway
Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz
Gdansk, , Poland
Biokinetica, Przychodnia Jozefow
Józefów, , Poland
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center - PPDS
Seoul, , South Korea
Samsung Medical Center - PPDS
Seoul, , South Korea
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario HM Sanchinarro-CIOCC
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Inselspital
Bern, , Switzerland
Hôpitaux Universitaires de Genève
Geneva, , Switzerland
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Velindre Cancer Centre
Cardiff, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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Sacher AG, Miller WH Jr, Patel MR, Paz-Ares L, Santoro A, Ahn MJ, Dziadziuszko R, Freres P, Luo J, Bowyer S, Desai J, Markman B, De Miguel M, Deva S, Falcon A, Alonso G, Guedes JD, Kim SH, Krebs MG, Laurie SA, Massarelli E, Medina L, Prenen H, Amatu A, Van Dongen M, Choi Y, Hou X, Qi T, Lin MT, Koli K, Mayo MC, Yau KK, Royer-Joo S, Chang J, Jun T, Dharia NV, Schutzman JL, Lorusso P; GO42144 Investigator Study group; GO42144 Investigator Study Group. Single-Agent Divarasib in Patients With KRAS G12C-Positive Non-Small Cell Lung Cancer: Long-Term Follow-Up of a Phase I Study. J Clin Oncol. 2025 Oct 20;43(30):3249-3253. doi: 10.1200/JCO-25-00040. Epub 2025 Jul 9.
Desai J, Alonso G, Kim SH, Cervantes A, Karasic T, Medina L, Shacham-Shmueli E, Cosman R, Falcon A, Gort E, Guren T, Massarelli E, Miller WH Jr, Paz-Ares L, Prenen H, Amatu A, Cremolini C, Kim TW, Moreno V, Ou SI, Passardi A, Sacher A, Santoro A, Stec R, Ulahannan S, Arbour K, Lorusso P, Luo J, Patel MR, Choi Y, Shi Z, Mandlekar S, Lin MT, Royer-Joo S, Chang J, Jun T, Dharia NV, Schutzman JL; GO42144 Investigator and Study Group; Han SW. Divarasib plus cetuximab in KRAS G12C-positive colorectal cancer: a phase 1b trial. Nat Med. 2024 Jan;30(1):271-278. doi: 10.1038/s41591-023-02696-8. Epub 2023 Dec 5.
Sacher A, LoRusso P, Patel MR, Miller WH Jr, Garralda E, Forster MD, Santoro A, Falcon A, Kim TW, Paz-Ares L, Bowyer S, de Miguel M, Han SW, Krebs MG, Lee JS, Cheng ML, Arbour K, Massarelli E, Choi Y, Shi Z, Mandlekar S, Lin MT, Royer-Joo S, Chang J, Dharia NV, Schutzman JL, Desai J; GO42144 Investigator and Study Group. Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation. N Engl J Med. 2023 Aug 24;389(8):710-721. doi: 10.1056/NEJMoa2303810.
Other Identifiers
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2020-000084-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506311-18-00
Identifier Type: OTHER
Identifier Source: secondary_id
GO42144
Identifier Type: -
Identifier Source: org_study_id
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