NL-201 + Pembrolizumab for Cancer

Recruiting at17 trial locations

Overseen by Albiruni A Razak

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Neurogene Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests the safety and effectiveness of NL-201 alone and with pembrolizumab in patients with advanced cancer. NL-201 may directly affect cancer cells, and pembrolizumab helps the immune system attack cancer. The goal is to find a safe and effective dose and schedule for these treatments. Pembrolizumab has shown efficacy and safety in treating various cancers, including melanoma.

Research Team

Albiruni A Razak

Principal Investigator

UHN - Princess Margaret Cancer Center

Eligibility Criteria

This trial is for adults with advanced solid tumors who have tried all approved treatments without success, or can't tolerate them. They must be at least 6 weeks out from certain cancer drugs and have a good performance status. People with prostate cancer, active COVID-19, recent transplants, ongoing immunosuppression, another progressing cancer within the last 2 years (except some skin cancers), or those on other investigational therapies are excluded.

Inclusion Criteria

I have an advanced solid tumor (not prostate cancer) and no standard treatments work for me.

I have the target disease or have been treated with pembrolizumab.

You haven't received nitrosurea or mitomycin C therapy for at least 6 weeks, any other chemotherapy or checkpoint inhibitor for at least 4 weeks, and any kinase inhibitor for at least 2 weeks. For Part 1 only: You have advanced solid tumor (excluding prostate cancer) that has either progressed, not responded well, or you are not eligible for any approved treatment options.

Exclusion Criteria

I have previously received IL-2-based cancer treatment.

I have another cancer besides the one being studied, but it hasn't needed treatment in the last 2 years.

I am not currently using any experimental treatments or devices.

Treatment Details

Interventions

• NL-201 (Other)
• Pembrolizumab (Monoclonal Antibodies)

Trial Overview The study tests NL-201 alone (Parts 1 & 2) and combined with Pembrolizumab (Parts 3 & 4) in patients with relapsed or refractory cancer. It aims to find safe dosages and schedules by evaluating how well participants tolerate these drugs and observing any potential benefits.

Participant Groups

Group I: Part 4: NL-201 in Combination with Pembrolizumab Expansion Cohorts Experimental Treatment 2 Interventions

NL-201 in combination with Pembrolizumab in indication specific cohorts at a dose and schedule determined in Part 3

Group II: Part 3: NL-201 in Combination with Pembrolizumab Dose Escalation Experimental Treatment 2 Interventions

NL-201, in combination with a set Pembrolizumab dose, testing ascending doses and two different schedules

Group III: Part 2: NL201 Monotherapy Expansion Cohorts Experimental Treatment 1 Intervention

NL-201 given as monotherapy by intravenous administration in indication specific cohorts at a dose and schedule determined in Part 1.

Group IV: Part 1: NL-201 Monotherapy Dose Escalation Experimental Treatment 1 Intervention

NL-201 given as monotherapy by intravenous administration testing ascending doses and two different schedules.

Who Is Running the Clinical Trial?

Neurogene Inc.

Lead Sponsor

Trials

6

Recruited

150+

Neoleukin Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

60+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University