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Completed

NCT Number: NCT05867121

A Study to Evaluate Safety, Pharmacokinetics, & 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; Urothelial Carcinoma Substudy in Association With RO7496353 Study GO44010

The purpose of this study is to evaluate the safety and tolerability of RO7496353 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 substudy will evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of RO7496353 in combination with atezolizumab in patients with locally advanced or metastatic urothelial carcinoma (UC).

The parent and substudy will be conducted in 2 stages: an initial safety run-in stage and an expansion stage.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Transitional Cell Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Ductal Adenocarcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St Vincent'S Hospital, Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of 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

  • 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.

Treatment and study plan

RO7496353

Drug

RO7496353 will be administered as per the schedules specified in the respective arms.

Other names: SOF 10

Atezolizumab

Drug

Atezolizumab will be administered as per the schedules specified in the respective arms.

Other names: RO5541267; Tecentriq

Capecitabine

Drug

Capecitabine will be administered as per the schedule specified in the respective arm.

S-1

Drug

S-1 will be administered as per the schedule specified in the respective arm.

Other names: Tegafur/Gimeracil/Oteracil potassium

Nivolumab

Drug

Nivolumab will be administered as per the schedule specified in the respective arm.

Oxaliplatin

Drug

Oxaliplatin will be administered as per the schedule specified in the respective arm.

Nab-paclitaxel

Drug

Nab-paclitaxel will be administered as per the schedule specified in the respective arm.

Gemcitabine

Drug

Gemcitabine will be administered as per the schedule specified in the respective arm.

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs)

    Time frame: Up to approximately 33 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 outcomes

  1. Plasma Concentration of RO7496353

    Time frame: Up to approximately 33 months

  2. Percentage of Participants With Anti-drug Antibody (ADA) to RO7496353

    Time frame: Up to approximately 33 months

  3. Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

    Time frame: Up to approximately 33 months

  4. Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1

    Time frame: Up to approximately 33 months

  5. Progression-free Survival (PFS) as Determined by the Investigator per RECIST v1.1

    Time frame: Up to approximately 33 months

Other outcomes

  1. Cohort A and C: Serum Concentration of Atezolizumab

    Time frame: Up to approximately 33 months

  2. Cohort A and C: Percentage of Participants With ADAs to Atezolizumab

    Time frame: Up to approximately 33 months

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Collaborators

  • Chugai Pharmaceutical

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 19, 2023
Registry last updated
Jun 18, 2026

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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