← Back to Search

Monoclonal Antibodies

REGN3767 +/− Cemiplimab for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group performance status of 0 or 1

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 42 months

Awards & highlights

Study Summary

This trial is studying the safety and pharmacokinetics of REGN3767 in patients with advanced malignancies, including lymphoma. The trial will also assess the preliminary anti-tumor activity of REGN3767 alone and in combination with cemiplimab.

Who is the study for?

This trial is for adults with advanced cancers, including lymphoma, that have progressed despite no available beneficial therapy. It's open to those who haven't tried PD-1/PD-L1 inhibitors and some who have. Participants need a certain level of physical fitness (ECOG status 0 or 1) and good organ/bone marrow function. Those with untreated brain metastases, recent heart attacks, ongoing autoimmune diseases, or recent radiation/corticosteroid treatments can't join.Check my eligibility

What is being tested?

The study tests REGN3767 alone and combined with cemiplimab in patients with advanced malignancies. Initially, it will determine safe dosages while checking how the body processes these drugs (dose escalation phase). Then it'll measure their effectiveness against tumors by observing response rates (dose expansion phase).See study design

What are the potential side effects?

Potential side effects may include immune-related reactions as both drugs are designed to activate the immune system which could lead to inflammation in various organs. Other common side effects might involve fatigue, skin reactions, changes in blood test results indicating liver or kidney issues.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 42 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 42 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 42 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

AUC computed from time zero to the time of the last positive concentration [AUClast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)

AUC from time zero extrapolated to infinity [AUCinf] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)

AUCall-to-dose ratio [AUCall/Dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)

+22 more

Secondary outcome measures

Best overall response based on Lugano criteria (Dose Escalation Phase)

Best overall response based on RECIST 1.1 criteria (Dose Escalation Phase)

Best overall response based on irRECIST criteria (Dose Escalation Phase)

+16 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Monotherapy (REGN3767)Experimental Treatment1 Intervention

Group A will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition 1 tumor-specific cohort will be treated at the recommended phase 2 dose (RP2D) during dose expansion.

Group II: Combination Therapy (REGN3767+cemiplimab)Experimental Treatment2 Interventions

Group B will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition, 9 tumor-specific cohorts will be treated at the RP2D during dose expansion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cemiplimab

2016

Completed Phase 2

~570

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiIndustry Sponsor

2,163 Previous Clinical Trials

3,512,147 Total Patients Enrolled

Regeneron PharmaceuticalsLead Sponsor

615 Previous Clinical Trials

379,514 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

259 Previous Clinical Trials

250,711 Total Patients Enrolled

Media Library

cemiplimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03005782 — Phase 1

Cancer Research Study Groups: Combination Therapy (REGN3767+cemiplimab), Monotherapy (REGN3767)

Cancer Clinical Trial 2023: cemiplimab Highlights & Side Effects. Trial Name: NCT03005782 — Phase 1

cemiplimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03005782 — Phase 1

Frequently Asked Questions

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

What is the geographic scope of this trial's implementation?

"As of now, there are 31 clinical trial sites spread throughout the nation. In addition to Houston, Grand Rapids and Fairway, many other cities have been incorporated into this study. If participants take part in the research they should opt for a nearby location to minimize their travel time needs."

Answered by AI

What medical issues is REGN3767 commonly used to address?

"REGN3767 is primarily prescribed to treat alk gene mutations, however it has also demonstrated efficacy in managing advanced directives, malignant neoplasms, and metastatic cutaneous squamous cell carcinoma."

Answered by AI

Are any new participants currently being recruited for this research?

"The aforementioned clinical trial is not currently recruiting patients, as the information on clinicialtrials.gov has demonstrated; first posted 11/7/2016 and most recently edited 8/25/2022. However, 2860 other studies are actively seeking candidates right now."

Answered by AI

Has there been any previous research conducted on REGN3767?

"Currently, 56 REGN3767 clinical trials are ongoing. Of these, 4 have reached the Phase 3 stage of development. Although most studies for this intervention are situated in Barcelona and California, 1741 locations worldwide have initiated trials with REGN3767."

Answered by AI

What have been the known ramifications of using REGN3767 as a therapeutic?

"The limited data on the safety and efficacy of REGN3767 only warrants a score of 1. At this stage in the clinical trial process, there is minimal supporting evidence."

Answered by AI

How many participants are joining this clinical research?

"This particular trial is no longer actively seeking participants, but according to clinicaltrials.gov there are 2804 different studies accepting patients with malignancies and 56 trials recruiting subjects for REGN3767."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers

2016. "Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03005782.

All > Oklahoma > Kansas