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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

NCT05867121 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-04-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

RO7496353

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

DRUG

Atezolizumab

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

DRUG

Capecitabine

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

DRUG

S-1

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

DRUG

Nivolumab

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

DRUG

Oxaliplatin

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

DRUG

Nab-paclitaxel

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

DRUG

Gemcitabine

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

Sponsors & Collaborators

  • Chugai Pharmaceutical

    collaborator INDUSTRY

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Italy
  • Japan
  • New Zealand
  • South Korea
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05867121 on ClinicalTrials.gov