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Monoclonal Antibodies

RO7496353 Combination Therapy for Metastatic Cancer

Phase 1

Waitlist Available

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 29 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of a new drug called RO7496353 when given together with another medication and possibly chemotherapy. They are studying participants with advanced or spreading solid tumors like lung, stomach,

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions from the drug entering the body, fatigue, blood disorders like anemia or clotting issues, nausea, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I can provide tumor samples as required.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 29 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 29 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 29 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants with Adverse Events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Capecitabine

2013

Completed Phase 3

~4280