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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006479-40 | EudraCT Number |
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The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of GDC-1971 when administered in combination with atezolizumab in participants with locally advanced or metastatic solid tumors.
The study will have 2 stages- dose finding stage and expansion stage. In expansion stage participants with non-small cell lung cancer programmed death ligand -1 high (NSCLC PD L-1 high), NSCLC PD L-1 low, head and neck squamous cell carcinoma (HNSCC) PD L-1 positive, BRAF wild type (BRAF WT) melanoma and any locally advanced or metastatic solid tumors will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-finding Stage: GDC-1971 | Experimental | Participants will receive GDC-1971 tablet or capsule at assigned dose, orally once daily (QD) on Days 1-21 of each cycle, along with atezolizumab 1200 milligrams (mg) intravenous (IV) infusion once every 3 weeks (Q3W), until unacceptable toxicity or loss of clinical benefit. A subset of participants will participate in evaluations regarding tablet versus (vs) capsule formulations. |
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| Expansion Stage: GDC-1971 | Experimental | Participants will receive GDC-1971 orally at the assigned dose QD on Days 1-21 of each cycle and atezolizumab 1200 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit. A subset of participants will participate in evaluations regarding tablet vs capsule formulation, the effect of food and acid-reducing agents on GDC-1971. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-1971 | Drug | Capsule or tablet administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | Up to approximately 2.5 years | |
| Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs | Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years) | |
| Percentage of Participants With Clinically Significant Change from Baseline in Clinical Laboratory Test Results | Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years) | |
| Percentage of Participants With Clinically Significant Change From Baseline in RR and QT Intervals as Measured by Electrocardiogram (ECG) | Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years) | |
| Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) | From Day 1 to Day 21 of Cycle 1 of the dose finding stage | |
| Plasma Concentration of GDC-1971 | Up to approximately 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to 96 hours (AUC0-96 hr) Following GDC-1971 Capsule or Tablet Administration | Up to approximately 2.5 years | |
| AUC From Time 0 to Infinity (AUCinf) Following GDC-1971 Capsule or Tablet Administration | Up to approximately 2.5 years |
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Inclusion Criteria:
Inclusion Criteria for Dose-Finding Stage:
Inclusion Criteria for Expansion Stage: NSCLC Cohort
Inclusion Criteria for Expansion Stage: HNSCC Cohort
Inclusion Criteria for Expansion Stage: BRAF WT melanoma Cohort
Inclusion Criteria for Expansion Stage: Other Advanced or Metastatic Solid Tumors Cohort
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanatorio Allende | Córdoba | X5000JHQ | Argentina | |||
| Fundacion CORI para la Investigacion y Prevencion del Cancer |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Atezolizumab | Drug | Administered as IV infusion. |
|
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| Omeprazole | Drug | Administered orally as tablet or capsule in the acid-reducing agent assessment. |
|
| Cmax of GDC-1971 Following Capsule or Tablet Administration | Up to approximately 2.5 years |
| AUC 0-96 hr Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions | Up to approximately 2.5 years |
| AUC inf Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions | Up to approximately 2.5 years |
| Cmax of GDC-1971 Following Tablet Administration Under Fasted and Fed Conditions | Up to approximately 2.5 years |
| AUC 0-24 hr at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole | Up to approximately 2.5 years |
| Cmax at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole | Up to approximately 2.5 years |
| Objective Response Rate (ORR) | Up to approximately 2.5 years |
| Duration of Response (DOR) | Up to approximately 2.5 years |
| Progression Free Survival (PFS) | Up to approximately 2.5 years |
| PFS Rate | Month 6 |
| Overall Survival (OS) Rate | Months 6 and 12 |
| La Rioja |
| F5300COE |
| Argentina |
| Centro Medico IPAM | Rosario | S2013SBK | Argentina |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Border Medical Oncology | Wodonga | New South Wales | 3690 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Austin Hospital | Heidelberg | Victoria | 3084 | Australia |
| One Clinical Research Perth | Nedlands | Western Australia | 6009 | Australia |
| Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner | Curitiba | Pará | 81520-060 | Brazil |
| Hospital de Clinicas de Porto Alegre HCPA PPDS | Porto Alegre | Pará | 90035-903 | Brazil |
| ONCOSITE Centro de Pesquisa Clínica Em Oncologia | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Fundacao Pio XII Hospital de Cancer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Fundação Doutor Amaral Carvalho - Hospital Amaral | Jaú | São Paulo | 17210-080 | 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 do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Instituto Brasileiro de Controle Do Câncer IBCC | São Paulo | 03102-006 | Brazil |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Chungbuk National University Hospital | Cheongju-si | 28644 | South Korea |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center - PPDS | Seoul | 05505 | South Korea |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 18, 2026 |
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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