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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-02
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2023-05-19
• Last updated: 2026-02-02

Locations

27 sites across 9 countries: United States, Australia, Brazil, Italy, Japan, New Zealand, South Korea, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study