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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

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ClinicalTrials.gov Identifier: NCT05487235
Recruitment Status : Recruiting
First Posted : August 4, 2022
Last Update Posted : November 23, 2022
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Metastatic Solid Tumors Drug: GDC-1971 Drug: Atezolizumab Drug: Omeprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 17, 2022
Estimated Primary Completion Date : May 31, 2025
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose-finding Stage: GDC-1971
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.
Drug: GDC-1971
Capsule or tablet administered orally.
Other Name: RO7517834, RLY-1971

Drug: Atezolizumab
Administered as IV infusion.
Other Name: RO5541267

Experimental: Expansion Stage: GDC-1971
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.
Drug: GDC-1971
Capsule or tablet administered orally.
Other Name: RO7517834, RLY-1971

Drug: Atezolizumab
Administered as IV infusion.
Other Name: RO5541267

Drug: Omeprazole
Administered orally as tablet or capsule in the acid-reducing agent assessment.




Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 2.5 years ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) [ Time Frame: From Day 1 to Day 21 of Cycle 1 of the dose finding stage ]
  6. Plasma Concentration of GDC-1971 [ Time Frame: Up to approximately 2.5 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. AUC From Time 0 to Infinity (AUCinf) Following GDC-1971 Capsule or Tablet Administration [ Time Frame: Up to approximately 2.5 years ]
  3. Cmax of GDC-1971 Following Capsule or Tablet Administration [ Time Frame: Up to approximately 2.5 years ]
  4. AUC 0-96 hr Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions [ Time Frame: Up to approximately 2.5 years ]
  5. AUC inf Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions [ Time Frame: Up to approximately 2.5 years ]
  6. Cmax of GDC-1971 Following Tablet Administration Under Fasted and Fed Conditions [ Time Frame: Up to approximately 2.5 years ]
  7. 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 ]
  8. Cmax at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole [ Time Frame: Up to approximately 2.5 years ]
  9. Objective Response Rate (ORR) [ Time Frame: Up to approximately 2.5 years ]
  10. Duration of Response (DOR) [ Time Frame: Up to approximately 2.5 years ]
  11. Progression Free Survival (PFS) [ Time Frame: Up to approximately 2.5 years ]
  12. PFS Rate [ Time Frame: Month 6 ]
  13. Overall Survival (OS) Rate [ Time Frame: Months 6 and 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Inclusion Criteria for Dose-Finding Stage:

  • 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

Inclusion Criteria for Expansion Stage: NSCLC Cohort

  • Histologically confirmed locally advanced or metastatic NSCLC
  • 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

Inclusion Criteria for Expansion Stage: HNSCC Cohort

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05487235


Contacts
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Contact: GO43712 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Argentina
Fundacion CORI para la Investigacion y Prevencion del Cancer Recruiting
La Rioja, Argentina, F5300COE
Australia, New South Wales
Border Medical Oncology Recruiting
Wodonga, New South Wales, Australia, 3690
Australia, Western Australia
One Clinical Research Perth Recruiting
Nedlands, Western Australia, Australia, 6009
Canada, Ontario
Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Korea, Republic of
Chungbuk National University Hospital Recruiting
Cheongju-si, Korea, Republic of, 28644
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT05487235    
Other Study ID Numbers: GO43712
2021-006479-40 ( EudraCT Number )
First Posted: August 4, 2022    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/ourmember/roche/). 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).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Atezolizumab
Omeprazole
Antineoplastic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action