RO7496353 Combination Therapy for Metastatic Cancer

Recruiting in Palo Alto (17 mi)

+35 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Genentech, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate the safety and tolerability of RO7496353 when administered 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 study will be conducted in 2 stages: an initial safety run-in stage and an expansion stage.

Eligibility Criteria

This trial is for adults with certain advanced cancers (like stomach, pancreatic, or non-small cell lung cancer) who are in fairly good health and have a life expectancy of at least 3 months. They must have measurable disease on scans and be able to provide tumor samples. People with poor performance status or inadequate organ function cannot join.

Inclusion Criteria

You are expected to live for at least 3 more months.

My cancer is advanced, has come back, or spread and cannot be cured.

I am fully active or restricted in physically strenuous activity but can do light work.

+3 more

Participant Groups

The study tests RO7496353 combined with checkpoint inhibitors (like Atezolizumab or Nivolumab) and may include standard chemotherapy drugs (Gemcitabine, Oxaliplatin, etc.). It's done in two parts: first checking safety and then seeing how well it works.

3Treatment groups

Experimental Treatment

Group I: Cohort C: PDACExperimental Treatment4 Interventions

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 disease progression.

Group II: Cohort B: GCExperimental Treatment5 Interventions

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 disease progression.

Group III: Cohort A: NSCLCExperimental Treatment2 Interventions

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.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: