A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
- Conditions
- Metastatic Solid TumorNon-small Cell Lung CancerGastric CancerPancreatic Ductal Adenocarcinoma
- Interventions
- Registration Number
- NCT05867121
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of RO7496353 when administered in combination with a checkpoint inhibitor (CPI) with or without standard-of-care (SOC) chemotherapy in participants with locally advanced or metastatic solid tumors such as non-small cell lung cancer (NSCLC), gastric cancer (GC) and pancreatic ductal adenocarcinoma (PDAC). The study will be conducted in 2 stages: an initial safety run-in stage and an expansion stage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 102
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy at least 3 months
- Adequate hematologic and end organ function
- Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
- Measurable disease according to RECIST v1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) images within 28 days prior to enrollment
- Availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks or at least 15 unstained slides
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 9 months after the final dose of oxaliplatin and within 6 months after the final dose of all other study treatment
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
- History of leptomeningeal disease
- Uncontrolled tumor-related pain
- Positive test for human immunodeficiency virus (HIV) infection
- Positive hepatitis B surface antigen (HbsAg) test, and/or positive total hepatitis B core antibody (HbcAb) test at screening
- Positive hepatitis C virus (HCV) antibody test at screening
- Known allergy or hypersensitivity to any component of the RO7496353 formulation or any of the study drugs or their excipients
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort B: GC Capecitabine Participants with GC will receive RO7496353, nivolumab, and oxaliplatin, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle along with either capecitabine or S-1, orally, twice daily on Days 1 to 14 of each cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression. Cohort C: PDAC Gemcitabine Participants with PDAC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, and gemcitabine, also given as an IV infusion on Days 1, 8, 15 of each 28-day cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression. Cohort C: PDAC RO7496353 Participants with PDAC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, and gemcitabine, also given as an IV infusion on Days 1, 8, 15 of each 28-day cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression. Cohort C: PDAC Atezolizumab Participants with PDAC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, and gemcitabine, also given as an IV infusion on Days 1, 8, 15 of each 28-day cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression. Cohort C: PDAC Nab-paclitaxel Participants with PDAC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, and gemcitabine, also given as an IV infusion on Days 1, 8, 15 of each 28-day cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression. Cohort A: NSCLC RO7496353 Participants with NSCLC will receive RO7496353, and atezolizumab, given as an intravenous (IV) infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression. Cohort B: GC RO7496353 Participants with GC will receive RO7496353, nivolumab, and oxaliplatin, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle along with either capecitabine or S-1, orally, twice daily on Days 1 to 14 of each cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression. Cohort B: GC S-1 Participants with GC will receive RO7496353, nivolumab, and oxaliplatin, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle along with either capecitabine or S-1, orally, twice daily on Days 1 to 14 of each cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression. Cohort A: NSCLC Atezolizumab Participants with NSCLC will receive RO7496353, and atezolizumab, given as an intravenous (IV) infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression. Cohort B: GC Nivolumab Participants with GC will receive RO7496353, nivolumab, and oxaliplatin, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle along with either capecitabine or S-1, orally, twice daily on Days 1 to 14 of each cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression. Cohort B: GC Oxaliplatin Participants with GC will receive RO7496353, nivolumab, and oxaliplatin, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle along with either capecitabine or S-1, orally, twice daily on Days 1 to 14 of each cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events (AEs) Up to approximately 29 months AEs will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Anti-Drug Antibody (ADA) to RO7496353 Up to approximately 29 months Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Up to approximately 29 months Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1 Up to approximately 29 months Progression Free Survival (PFS) as Determined by the Investigator per RECIST v1.1 Up to approximately 29 months Plasma Concentration of RO7496353 Up to approximately 29 months
Trial Locations
- Locations (30)
Ege University Medical Faculty
🇹🇷Izmir, Turkey
Dokuz Eylul Universitesi Tip Fakultesi
🇹🇷Lzmir, Turkey
UCLA University of California Los Angeles
🇺🇸Los Angeles, California, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
St Vincent'S Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Câncer de Barretos
🇧🇷Barretos, São Paulo, Brazil
Fondazione Policlinico Universitario A Gemelli
🇮🇹Roma, Lazio, Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
🇮🇹Milano, Lombardia, Italy
Centro Ricerche Cliniche Di Verona
🇮🇹Verona, Veneto, Italy
National Cancer Center Hospital East
🇯🇵Chiba, Japan
Kanagawa Cancer Center
🇯🇵Kanagawa, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
🇯🇵Tokyo, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center - PPDS
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy
🇰🇷Seoul, Korea, Republic of
Auckland City Hospital
🇳🇿Auckland, New Zealand
University Clinical Center of Serbia -PPDS
🇷🇸Belgrade, Serbia
Clinical Hospital Center Bezanijska Kosa
🇷🇸Belgrade, Serbia
University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
NEXT Oncology-Hospital Quironsalud Madrid
🇪🇸Pozuelo de Alarcon, Madrid, Spain
Clinica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
Clinica Universidad de Navarra-Madrid
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Ankara City Hospital
🇹🇷Ankara, Turkey