OncRef

Clinical Trial: 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

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Genentech, Inc.
Information Provided By:Genentech, Inc.
Last Update Posted:2026-06-18

Study Overview

Brief 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.

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

Conditions

Non-small Cell Lung Cancer, Gastric Cancer, Pancreatic Ductal Adenocarcinoma

Intervention / Treatment

  • Drug: RO7496353
  • Drug: Atezolizumab
  • Drug: Capecitabine
  • Drug: S-1
  • Drug: Nivolumab
  • Drug: Oxaliplatin
  • Drug: Nab-paclitaxel
  • Drug: Gemcitabine

Other Study ID Numbers

  • GO44010
  • 2022-502615-11-00

Start Date (Actual)

2023-10-02

Primary Completion Date (Actual)

2026-03-16

Study Completion Date (Actual)

2026-03-16

Enrollment (Actual)

102

Study Type

Interventional

Phase

Phase 1