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Monoclonal Antibodies

PD1-LAG3 Bispecific Antibody for Solid Tumors

Phase 1 & 2

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Prior treatment with an approved anti-PD-1 or anti-PD-L1 agent

Histologically confirmed, unresectable stage III or stage IV melanoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is testing a new cancer drug that targets two proteins, PD-1 and LAG-3. The goal is to find the maximum tolerated dose and see if it has any anti-tumor activity.

Who is the study for?

This trial is for adults with certain advanced solid tumors, including melanoma and non-small cell lung cancer. Participants must have tried standard treatments without success or cannot tolerate them. They should be in good physical condition (ECOG 0-1) and agree to use birth control. Those with more than two prior treatments for metastatic disease or specific genetic mutations are excluded.Check my eligibility

What is being tested?

The study tests RO7247669, a new bispecific antibody targeting PD-1 and LAG-3 proteins on immune cells, which may help the body fight cancer. It's an early-phase trial to find the safest dose with potential anti-cancer effects in patients who've had previous treatments like PD-L1/PD-1 inhibitors.See study design

What are the potential side effects?

Potential side effects of RO7247669 could include reactions related to the immune system such as inflammation in various organs, fatigue, infusion-related reactions, infections due to lowered immunity, and possibly others not yet known due to its experimental nature.

Eligibility Criteria

Inclusion Criteria

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

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I have been treated with drugs targeting PD-1 or PD-L1.

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My melanoma is at an advanced stage and cannot be surgically removed.

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My cancer is advanced or has spread, and standard treatments are not suitable for me.

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My lung cancer is confirmed to be advanced non-small cell type.

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My tumor has been tested for PD-L1 protein.

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I am fully active or can carry out light work.

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I have had 2 or fewer treatments for my cancer after it spread.

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I have been treated with PD-L1/PD-1 inhibitors before.

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My main cancer lesion is confirmed as squamous or adenosquamous cell carcinoma of the esophagus.

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I have had only one treatment for my cancer after it spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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

Part A: Percentage of Participants with Adverse Events

Part A: Percentage of Participants with Dose-Limiting Toxicities (DLTs)

Part B: Disease Control Rate (DCR), Defined as ORR + Stable Disease Rate (SDR)

+3 more

Secondary outcome measures

Part A: DCR

Part A: DOR

Part A: ORR

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B: Tumor Specific Expansion CohortsExperimental Treatment1 Intervention

Participants with selected solid tumor indications will receive RO7247669 at a dose derived from Part A until disease progression, unacceptable drug toxicity, or withdrawal of consent, for up to 24 months.

Group II: Part A: Single-Agent Dose EscalationExperimental Treatment1 Intervention

Participants will receive RO7247669 every 2 weeks (Q2W) or every 3 weeks (Q3W) up to the maximum tolerated dose (MTD) until disease progression, unacceptable drug toxicity, or withdrawal of consent, for up to 24 months.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,089,903 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,620 Total Patients Enrolled

Media Library

RO7247669 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04140500 — Phase 1 & 2

Esophageal Cancer Research Study Groups: Part A: Single-Agent Dose Escalation, Part B: Tumor Specific Expansion Cohorts

Esophageal Cancer Clinical Trial 2023: RO7247669 Highlights & Side Effects. Trial Name: NCT04140500 — Phase 1 & 2

RO7247669 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04140500 — Phase 1 & 2

Frequently Asked Questions

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

Has regulatory approval been granted for RO7247669?

"RO7247669's safety has been assessed as a 1 on our scale due to the limited data available at this stage of its clinical trial."

Answered by AI

Is there availability for subjects to join this research endeavor?

"Per the information indexed on clinicaltrials.gov, this experiment is presently recruiting patients to take part. It was unveiled on 11/11/2019 and recently modified on 11/8/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors

2019. "Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04140500.