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
Phase 1
Completed
- Conditions
- Advanced Solid TumorsMetastatic Solid Tumors
- Interventions
- Registration Number
- NCT05487235
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Expansion Stage: GDC-1971 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. Dose-finding Stage: GDC-1971 Atezolizumab 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. Dose-finding Stage: GDC-1971 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. Expansion Stage: GDC-1971 Atezolizumab 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. Expansion Stage: GDC-1971 Omeprazole 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) Up to approximately 2.5 years Plasma Concentration of GDC-1971 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 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 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)
- Secondary Outcome Measures
Name Time Method 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 Cmax of GDC-1971 Following Capsule or Tablet Administration Up to approximately 2.5 years AUC inf Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions Up to approximately 2.5 years Objective Response Rate (ORR) Up to approximately 2.5 years Progression Free Survival (PFS) 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 Cmax of GDC-1971 Following Tablet Administration Under Fasted and Fed Conditions Up to approximately 2.5 years PFS Rate Month 6 Overall Survival (OS) Rate Months 6 and 12 AUC 0-96 hr Following GDC-1971 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 Duration of Response (DOR) Up to approximately 2.5 years
Trial Locations
- Locations (25)
ONCOSITE Centro de Pesquisa Clínica Em Oncologia
🇧🇷Ijuí, Rio Grande Do Sul, Brazil
Sanatorio Allende
🇦🇷Cordoba, Argentina
Fundacion CORI para la Investigacion y Prevencion del Cancer
🇦🇷La Rioja, Argentina
Centro Medico IPAM
🇦🇷Rosario, Argentina
St Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Border Medical Oncology
🇦🇺Wodonga, New South Wales, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
One Clinical Research Perth
🇦🇺Nedlands, Western Australia, Australia
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
🇧🇷Curitiba, Pará, Brazil
Scroll for more (15 remaining)ONCOSITE Centro de Pesquisa Clínica Em Oncologia🇧🇷Ijuí, Rio Grande Do Sul, Brazil