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NCT05867121 | Recruiting | Metastatic Solid Tumor

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
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.

Condition or disease

Metastatic Solid Tumor

Non-small Cell Lung Cancer

Gastric Cancer

Pancreatic Ductal Adenocarcinoma

Intervention/treatment

Spirit 496353

Atezolizumab

Capecitabine

S-1

Nivolumab

Oxaliplatin

Nab-paclitaxel

Gemcitabine

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 120 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : A Phase Ib, Open-Label, Multicenter Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : October 2, 2023
Estimated Primary Completion Date : December 30, 2025
Estimated Study Completion Date : December 30, 2025
Arm Intervention/treatment

Experimental: Cohort A: NSCLC

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.

Drug: RO7496353

Other: Atezolizumab

Drug: RO7496353

Experimental: Cohort B: GC

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.

Drug: Capecitabine

Friend: S-1

Drug: Nivolumab

Experimental: Cohort C: PDAC

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.

Drug: Oxaliplatin

Drug: RO7496353

Other: Atezolizumab
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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.
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

Location Details

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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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, California

UCLA University of California Los Angeles

The Angels, California, United States, 90095

Recruiting

United States, Connecticut

Yale School of Medicine

New Haven, Connecticut, United States, 06510-3206

Recruiting

United States, Pennsylvania

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Recruiting

Australia, New South Wales

St Vincent'S Hospital

Darlinghurst, New South Wales, Australia, 2010

Recruiting

Australia, South Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia, 5042

Recruiting

Brazil, RS

Sao Lucas Hospital at the Pontifical Catholic University of Rio Grande do Sul (PUCRS)

Porto Alegre, RS, Brazil, 90610-000

Recruiting

Italy, Lazio

A Gemelli University Hospital Foundation

Roma, Lazio, Italy, 00168

Recruiting

Italy, Veneto

Integrated University Hospital of Verona

Verona, Veneto, Italy, 37126

Recruiting

Japan, Madrid

National Cancer Center Hospital East

Chiba, Madrid, Japan, 277-8577

Recruiting

Japan, Navarra

Kanagawa Cancer Center

Kanagawa, Navarra, Japan, 241-8515

Recruiting

Japan,

Shizuoka Cancer Center

Shizuoka, Japan, 411-8777

Recruiting

Japan,

National Cancer Center Hospital

Tokyo, Japan, 104-0045

Recruiting

Japan,

The Cancer Institute Hospital of Japanese Foundation For Cancer Research

Tokyo, Japan, 135-8550

Recruiting

Korea, Republic of,

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Recruiting

Korea, Republic of,

Asan Medical Center

Seoul, Korea, Republic of, 05505

Recruiting

Korea, Republic of,

Samsung Medical Center - PPDS

Seoul, Korea, Republic of, 06351

Recruiting

Korea, Republic of,

Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy

Seoul, Korea, Republic of, 120-752

Recruiting

New Zealand,

Auckland City Hospital

Auckland, New Zealand, 1023

Recruiting

Spain,

NEXT Oncology-Hospital Quironsalud Madrid

Pozuelo de Alarcon, Spain, 28223

Recruiting

Spain,

University Clinic of Navarra

Pamplona, Spain, 31008

Recruiting

Spain,

University of Navarra-Madrid Clinic

Madrid, Spain, 28027

Recruiting

Spain,

Valencia University Clinical Hospital

Valencia, Spain, 46010