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Completed

NCT Number: NCT05487235

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sanatorio Allende, Córdoba, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDC-1971

Drug

Capsule or tablet administered orally.

Other names: RO7517834, RLY-1971

Atezolizumab

Drug

Administered as IV infusion.

Other names: RO5541267

Omeprazole

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 4, 2022
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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