A Phase 1 interventional study of RO7496353 and Atezolizumab in Non-small Cell Lung Cancer, Gastric Cancer and Pancreatic Ductal Adenocarcinoma, sponsored by Genentech, Inc.. Completed at 27 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 1, Interventional, and Treatment
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.
6,491 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,633 are open to participants now.
This study's enrollment of 102 is above the median of 62 across 5,216 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
First submitted after Genentech, Inc. became part of Hoffmann-La Roche.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Participants with NSCLC will receive RO7496353, and atezolizumab, given as an intravenous (IV) infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression (PD).
Drug: RO7496353 · Drug: Atezolizumab
Participants with GC will receive RO7496353, nivolumab, and oxaliplatin, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle along with either capecitabine or S-1, orally, twice daily on Days 1 to 14 of each cycle until unacceptable toxicity or symptomatic deterioration attributed to PD.
Drug: RO7496353 · Drug: Capecitabine · Drug: S-1 · Drug: Nivolumab · Drug: Oxaliplatin
Participants with PDAC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, and gemcitabine, also given as an IV infusion on Days 1, 8, 15 of each 28-day cycle until unacceptable toxicity or symptomatic deterioration attributed to PD.
Drug: RO7496353 · Drug: Atezolizumab · Drug: Nab-paclitaxel · Drug: Gemcitabine
Participants with UC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to PD.
Drug: RO7496353 · Drug: Atezolizumab
RO7496353 will be administered as per the schedules specified in the respective arms.
Also known as: SOF 10
Atezolizumab will be administered as per the schedules specified in the respective arms.
Also known as: RO5541267; Tecentriq
Capecitabine will be administered as per the schedule specified in the respective arm.
S-1 will be administered as per the schedule specified in the respective arm.
Also known as: Tegafur/Gimeracil/Oteracil potassium
Nivolumab will be administered as per the schedule specified in the respective arm.
Oxaliplatin will be administered as per the schedule specified in the respective arm.
Nab-paclitaxel will be administered as per the schedule specified in the respective arm.
Gemcitabine will be administered as per the schedule specified in the respective arm.
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).
Time frame: Up to approximately 33 months
Plasma Concentration of RO7496353
Time frame: Up to approximately 33 months
Percentage of Participants With Anti-drug Antibody (ADA) to RO7496353
Time frame: Up to approximately 33 months
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
Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1
Time frame: Up to approximately 33 months
Progression-free Survival (PFS) as Determined by the Investigator per RECIST v1.1
Time frame: Up to approximately 33 months
Cohort A and C: Serum Concentration of Atezolizumab
Time frame: Up to approximately 33 months
Cohort A and C: Percentage of Participants With ADAs to Atezolizumab
Time frame: Up to approximately 33 months
Plan to share: No
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→