Advanced Solid TumorsPhase 1NCT05487235
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing GDC-1971, Atezolizumab and Omeprazole in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Genentech, Inc. at 25 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Metastatic Solid Tumors
- What is being tested?
- GDC-1971, Atezolizumab and Omeprazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 25 sitesin 6 countries
- Study dates
- 17 Aug 2022to 23 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1
- Has Life expectancy >= 12 weeks
- Adequate organ function
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
- Histologically confirmed locally advanced or metastatic solid tumor that has progressed after at least one available standard therapy or for which approved standard therapy has proven to be ineffective or intolerable
- Histologically confirmed locally advanced or metastatic NSCLC
Show all 16Show fewer
- Absence of epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK)
- PD- L1 positive
- No prior systemic therapy for locally advanced or metastatic NSCLC
- Histologically confirmed recurrent, or metastatic HNSCC
- PD-L1 positive
- No prior systemic therapy for recurrent or metastatic HNSCC
- Inclusion Criteria for Expansion Stage: BRAF WT melanoma Cohort
- Histologically confirmed locally advanced or metastatic or unresectable locally advanced cutaneous BRAF WT melanoma or melanomas of unknown primary that are non-mucosal and non -uveal that has progressed on or after treatment that included anti PD1 or anti PD-L1 therapy
- Inclusion Criteria for Expansion Stage: Other Advanced or Metastatic Solid Tumors Cohort
- Histologically confirmed locally advanced or metastatic solid tumor that has progressed after at least one available standard therapy or for which approved standard therapy has proven to be ineffective or intolerable, standard therapy is considered inappropriate, or an investigational agent is a recognized standard of care
Who cannot join
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
- Has leptomeningeal disease or carcinomatous meningitis
- Has uncontrolled hypertension
- Has left ventricular ejection fraction < institutional lower limit of normal or < 50%
- Has clinically significant history of liver disease including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Has an active or history of autoimmune disease or immune deficiency including myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or multiple sclerosis. Participants with a history of autoimmune- related hypothyroidism on thyroid replacement hormone or with controlled Type I diabetes mellitus on a stable dose of an insulin regimen are eligible for this study
Trial locations and contacts
25 sites in 6 countries.
25 sites in 6 countries
Brazil8 sites
Fundacao Pio XII Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
Curitiba, Pará, 81520-060
ONCOSITE Centro de Pesquisa Clínica Em Oncologia
Ijuí, Rio Grande do Sul, 98700-000
Fundação Doutor Amaral Carvalho - Hospital Amaral
Jaú, São Paulo, 17210-080
Hospital de Clinicas de Porto Alegre HCPA PPDS
Porto Alegre, Pará, 90035-903
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto, São Paulo, 15090-000
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000
Instituto Brasileiro de Controle Do Câncer IBCC
São Paulo, 03102-006
Australia5 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
Austin Hospital
Heidelberg, Victoria, 3084
One Clinical Research Perth
Nedlands, Western Australia, 6009
Border Medical Oncology
Wodonga, New South Wales, 3690
South Korea5 sites
Chungbuk National University Hospital
Cheongju-si, 28644
National Cancer Center
Goyang-si, 10408
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center - PPDS
Seoul, 05505
Argentina3 sites
Sanatorio Allende
Córdoba, X5000JHQ
Fundacion CORI para la Investigacion y Prevencion del Cancer
La Rioja, F5300COE
Centro Medico IPAM
Rosario, S2013SBK
Canada3 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase Ib, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
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.
- Conditions
- Advanced Solid Tumors, Metastatic Solid Tumors
- Being tested
- GDC-1971, Atezolizumab, Omeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-1971Drug
Also called RO7517834, RLY-1971
Capsule or tablet administered orally.
AtezolizumabDrug
Also called RO5541267
Administered as IV infusion.
OmeprazoleDrug
Administered orally as tablet or capsule in the acid-reducing agent assessment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: GDC-1971; Drug: Atezolizumab |
| 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. Receives: Drug: GDC-1971; Drug: Atezolizumab; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
Measured: Up to approximately 2.5 years
Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs
Measured: 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
Measured: 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)
Measured: 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)
Measured: From Day 1 to Day 21 of Cycle 1 of the dose finding stage
Plasma Concentration of GDC-1971
Measured: Up to approximately 2.5 years
Secondary outcomes (13)
Area Under the Concentration-Time Curve From Time 0 to 96 hours (AUC0-96 hr) Following GDC-1971 Capsule or Tablet Administration
Measured: Up to approximately 2.5 years
AUC From Time 0 to Infinity (AUCinf) Following GDC-1971 Capsule or Tablet Administration
Measured: Up to approximately 2.5 years
Cmax of GDC-1971 Following Capsule or Tablet Administration
Measured: Up to approximately 2.5 years
AUC 0-96 hr Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions
Measured: Up to approximately 2.5 years
AUC inf Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions
Measured: Up to approximately 2.5 years
Cmax of GDC-1971 Following Tablet Administration Under Fasted and Fed Conditions
Measured: Up to approximately 2.5 years
AUC 0-24 hr at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole
Measured: Up to approximately 2.5 years
Cmax at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole
Measured: Up to approximately 2.5 years
Objective Response Rate (ORR)
Measured: Up to approximately 2.5 years
Duration of Response (DOR)
Measured: Up to approximately 2.5 years
Progression Free Survival (PFS)
Measured: Up to approximately 2.5 years
PFS Rate
Measured: Month 6
Overall Survival (OS) Rate
Measured: Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start17 Aug 2022
- Primary completion23 Jun 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487235
- Sponsor's protocol ID
- GO43712
- Other IDs
- 2021-006479-40
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2022
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05487235
- Acronym / sponsor ID
- GO43712
- Conditions
- Advanced Solid Tumors, Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose-finding Stage: GDC-1971 | Experimental | Drug: GDC-1971, Drug: AtezolizumabParticipants 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. |
| Expansion Stage: GDC-1971 | Experimental | Drug: GDC-1971, Drug: Atezolizumab, Drug: OmeprazoleParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Has Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1
- Has Life expectancy >= 12 weeks
- Adequate organ function
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
- Histologically confirmed locally advanced or metastatic solid tumor that has progressed after at least one available standard therapy or for which approved standard therapy has proven to be ineffective or intolerable
Key exclusion criteria (6 listed)
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
- Has leptomeningeal disease or carcinomatous meningitis
- Has uncontrolled hypertension
- Has left ventricular ejection fraction < institutional lower limit of normal or < 50%
- Has clinically significant history of liver disease including viral or other hepatitis, current alcohol abuse, or cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDC-1971Also: RO7517834, RLY-1971Capsule or tablet administered orally. | Drug | Dose-finding Stage: GDC-1971, Expansion Stage: GDC-1971 |
| AtezolizumabAlso: RO5541267Administered as IV infusion. | Drug | Dose-finding Stage: GDC-1971, Expansion Stage: GDC-1971 |
| OmeprazoleAdministered orally as tablet or capsule in the acid-reducing agent assessment. | Drug | Expansion Stage: GDC-1971 |
Primary outcome
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 2.5 years
Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: From Day 1 to Day 21 of Cycle 1 of the dose finding stage
Plasma Concentration of GDC-1971
Time frame: Up to approximately 2.5 years
13 secondary outcomes
Area Under the Concentration-Time Curve From Time 0 to 96 hours (AUC0-96 hr) Following GDC-1971 Capsule or Tablet Administration
Time frame: Up to approximately 2.5 years
AUC From Time 0 to Infinity (AUCinf) Following GDC-1971 Capsule or Tablet Administration
Time frame: Up to approximately 2.5 years
Cmax of GDC-1971 Following Capsule or Tablet Administration
Time frame: Up to approximately 2.5 years
AUC 0-96 hr Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions
Time frame: Up to approximately 2.5 years
AUC inf Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions
Time frame: Up to approximately 2.5 years
Cmax of GDC-1971 Following Tablet Administration Under Fasted and Fed Conditions
Time frame: Up to approximately 2.5 years
AUC 0-24 hr at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole
Time frame: Up to approximately 2.5 years
Cmax at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole
Time frame: Up to approximately 2.5 years
Objective Response Rate (ORR)
Time frame: Up to approximately 2.5 years
Duration of Response (DOR)
Time frame: Up to approximately 2.5 years
Progression Free Survival (PFS)
Time frame: Up to approximately 2.5 years
PFS Rate
Time frame: Month 6
Overall Survival (OS) Rate
Time frame: Months 6 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GDC-1971, Atezolizumab and Omeprazole in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Genentech, Inc. at 25 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Brazil, Australia, South Korea, Argentina, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (AEs) (time frame: Up to approximately 2.5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.