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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000084-22 | EudraCT Number | ||
| 2023-506311-18-00 | Other Identifier | EU CT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II) | Experimental | 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. |
|
| Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II) | Experimental | Participants with non-small cell lung cancer will receive GDC-6036 in combination with atezolizumab. |
|
| Arm C: GDC-6036 + Cetuximab (Stage I and Stage II) | Experimental | Participants with colorectal cancer will receive GDC-6036 in combination with cetuximab. |
|
| Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II) | Experimental | Participants with solid tumors will receive GDC-6036 in combination with bevacizumab. |
|
| Arm E: GDC-6036 + Erlotinib (Stage I and Stage II) | Experimental | Participants with non-small cell lung cancer will receive GDC-6036 in combination with erlotinib. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | 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) | From Cycle 1 Day 1 through Day 21. A cycle is 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of GDC-6036 | 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States | ||
| UCSD Moores Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40632992 | Derived | 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. | |
| 38052910 |
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|
| Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II) | Experimental | 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. |
|
| Arm G: GDC-6036 + Inavolisib (Stage I and Stage II) | Experimental | 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. |
|
| 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. |
|
| Plasma Concentrations of GDC-1971 | 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 | 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) | 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 | 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 | 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]) | 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]) | 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]) | 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]) | 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 | 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. |
| La Jolla |
| California |
| 92093 |
| United States |
| Chao Family Comprehensive Cancer Center UCI | Orange | California | 92868 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06511 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC - Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Slade Health Inward goods | Mount Kuring-Gai | New South Wales | 2080 | Australia |
| Peter MacCallum Cancer Center | Melbourne | Victoria | 3000 | Australia |
| Alfred Health | Melbourne | Victoria | 3004 | Australia |
| Linear Clinical Research Limited | Nedlands | Western Australia | 6009 | Australia |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| CHU de Liège | Liège | 4000 | Belgium |
| AZ St Maarten Campus Leopoldstr | Mechelen | 2800 | Belgium |
| Santa Casa de Misericordia de Belo Horizonte - PPDS | Belo Horizonte | Minas Gerais | 30150-221 | Brazil |
| Hospital Erasto Gaertner | Curitiba | Paraná | 81520-060 | Brazil |
| Hospital de Clinicas de Porto Alegre HCPA PPDS | Porto Alegre | Pará | 90035-903 | Brazil |
| Universidade de Caxias do Sul | Caxias do Sul | Rio Grande do Sul | 95070-561 | Brazil |
| Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Instituto Nacional de Câncer | Rio de Janeiro | 20230-130 | Brazil |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Clinexpert Gyongyos Kft | Gyöngyös | 3200 | Hungary |
| Rambam Medical Center | Haifa | 3109601 | Israel |
| Sheba Medical Center - PPDS | Ramat Gan | 52621 | Israel |
| Tel-Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS | Meldola | Emilia-Romagna | 47014 | Italy |
| Irccs Ospedale San Raffaele | Milan | Lombardy | 20132 | Italy |
| Asst Grande Ospedale Metropolitano Niguarda | Milan | Lombardy | 20162 | Italy |
| Istituto Clinico Humanitas | Rozzano (MI) | Lombardy | 20089 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Tuscany | 56100 | Italy |
| The Aga Khan University-Kenya. | Nairobi | 00100 | Kenya |
| Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis | Amsterdam | 1066 CX | Netherlands |
| Leids Universitair Medisch Centrum | Leiden | 2333 ZA | Netherlands |
| Maastricht University Medical Center | Maastricht | 6229 HX | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | 3584 CX | Netherlands |
| Auckland City Hospital, Cancer and Blood Research | Auckland | 1023 | New Zealand |
| Auckland City Hospital | Auckland | New Zealand |
| New Zealand Clinical Research - Christchurch | Christchurch | New Zealand |
| Haukeland University Hospital | Bergen | 5020 | Norway |
| Oslo university hospital Radiumhospitalet | Oslo | 0424 | Norway |
| Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz | Gdansk | 80-214 | Poland |
| Biokinetica, Przychodnia Jozefow | Józefów | 05-410 | Poland |
| Seoul National University Bundang Hospital | Seongnam-si | 13605 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center - PPDS | Seoul | 05505 | South Korea |
| Samsung Medical Center - PPDS | Seoul | 06351 | South Korea |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| START Madrid-FJD, Hospital Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario HM Sanchinarro-CIOCC | Madrid | 28050 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Inselspital | Bern | 3010 | Switzerland |
| Hôpitaux Universitaires de Genève | Geneva | 1211 | Switzerland |
| Queen Elizabeth Hospital | Birmingham | B15 2GW | United Kingdom |
| Velindre Cancer Centre | Cardiff | CF14 2TL | United Kingdom |
| University College London - PPDS | London | WC1N 3BG | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Derived |
| 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. |
| 37611121 | Derived | 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. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000068818 | Cetuximab |
| D000068258 | Bevacizumab |
| D000069347 | Erlotinib Hydrochloride |
| C000723546 | inavolisib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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