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Monoclonal Antibodies

Cohort A: NSCLC for Stomach Cancer

Phase 1

Recruiting

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Adverse Events (AEs)

Secondary outcome measures

Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1

Percentage of Participants with Anti-Drug Antibody (ADA) to RO7496353

+2 more

Other outcome measures

Cohort A and C: Percentage of Participants with ADA to Atezolizumab

Cohort A and C: Serum Concentration of Atezolizumab

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

2017

Completed Phase 3

~5860

Capecitabine

2013

Completed Phase 3

~3420

Gemcitabine

2017

Completed Phase 3

~2070

Nab-paclitaxel

2014

Completed Phase 3

~2030

Nivolumab

2014

Completed Phase 3

~4750

S-1

2013

Completed Phase 3

~2400

Oxaliplatin

2011

Completed Phase 4

~2560

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,541 Previous Clinical Trials

568,023 Total Patients Enrolled

Chugai Pharmaceutical Co.UNKNOWN

3 Previous Clinical Trials

302 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,758 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At present, how many distinct locations are simultaneously conducting this experimental investigation?

"This clinical trial is currently being conducted at a total of 17 sites. These sites are based in various locations, including Seoul, Valencia, Pozuelo de Alarcon, and other additional places. If you decide to enroll in the study, it is advised to choose the site that is nearest to your location in order to minimize travel requirements."

Answered by AI

What is the current number of individuals being recruited for participation in this research study?

"Indeed, the details on clinicaltrials.gov highlight that this research study is actively seeking individuals to participate. The trial was originally posted on October 2nd, 2023 and most recently updated on December 21st, 2023. A total of 120 participants will be enrolled across 17 different locations."

Answered by AI

Has Cohort B: GC received the official approval from the Food and Drug Administration (FDA)?

"Given that this trial is classified as Phase 1, our team at Power has assigned a safety rating of 1 to Cohort B: GC. This indicates that there is limited available data supporting both the safety and efficacy of the intervention."

Answered by AI

Are patients currently being enrolled in this ongoing medical study?

"Indeed, as stated on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The study was initially posted for recruitment purposes on October 2nd, 2023 and underwent its most recent update on December 21st, 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety, Pharmacokinetics, and 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

2023. "A Study to Evaluate the Safety, Pharmacokinetics, and 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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05867121.