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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867121
• Other study ID #: GO44010
• Secondary ID: 2022-502615-11-0
• Status: Recruiting
• Phase: Phase 1
• Start date: October 2, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2024
• Source: Genentech, Inc.
• Contact: Reference Study ID Number: GO44010 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer
• Metastatic Solid Tumor
• Non-small Cell Lung Cancer
• Pancreatic Ductal Adenocarcinoma

Intervention

Drug:
• RO7496353
RO7496353 will be administered as per the schedules specified in the respective arms.
• Atezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.
• Capecitabine
Capecitabine will be administered as per the schedules specified in the respective arms
• S-1
S-1 will be administered as per the schedules specified in the respective arms.
• Nivolumab
Nivolumab will be administered as per the schedules specified in the respective arms.
• Oxaliplatin
Oxaliplatin will be administered as per the schedules specified in the respective arms.
• Nab-paclitaxel
Nab-paclitaxel will be administered as per the schedules specified in the respective arms.
• Gemcitabine
Gemcitabine will be administered as per the schedules specified in the respective arms.

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	St Vincent'S Hospital	Darlinghurst	New South Wales
Brazil	Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)	Porto Alegre	RS
Italy	Fondazione Policlinico Universitario A Gemelli	Roma	Lazio
Italy	Azienda Ospedaliera Universitaria Integrata di Verona	Verona	Veneto
Japan	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
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center - PPDS	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy	Seoul
New Zealand	Auckland City Hospital	Auckland
Spain	Clinica Universidad de Navarra-Madrid	Madrid
Spain	Clinica Universitaria de Navarra	Pamplona	Navarra
Spain	NEXT Oncology-Hospital Quironsalud Madrid	Pozuelo de Alarcon	Madrid
Spain	Hospital Clinico Universitario de Valencia	Valencia
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Genentech, Inc.	Chugai Pharmaceutical Co.

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Italy,  Japan,  Korea, Republic of,  New Zealand,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cohort A and C: Serum Concentration of Atezolizumab		Up to approximately 29 months
Other	Cohort A and C: Percentage of Participants with ADA to Atezolizumab		Up to approximately 29 months
Primary	Percentage of Participants with Adverse Events (AEs)	AEs will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).	Up to approximately 29 months
Secondary	Plasma Concentration of RO7496353		Up to approximately 29 months
Secondary	Percentage of Participants with Anti-Drug Antibody (ADA) to RO7496353		Up to approximately 29 months
Secondary	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
Secondary	Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1		Up to approximately 29 months
Secondary	Progression Free Survival (PFS) as Determined by the Investigator per RECIST v1.1		Up to approximately 29 months