M1774 + Cemiplimab for Advanced Lung Cancer

Recruiting in Palo Alto (17 mi)

+53 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: EMD Serono Research & Development Institute, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This is an Open-label, multicenter clinical study conducted in two Phases to establish the efficacy, safety, tolerability, and pharmacokinetics of the ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor Tuvusertib in Combination with Cemiplimab in Participants with Non-Squamous Non-Small Cell Lung Cancer (nsqNSCLC) that has Progressed on Prior Anti-PD-(L)1 and Platinum-based Therapies..

Eligibility Criteria

This trial is for adults with non-squamous Non-Small Cell Lung Cancer (nsqNSCLC) that worsened after anti-PD-(L)1 and platinum-based treatments. They must have shown some positive response to previous therapies, have measurable disease, be in good physical condition (ECOG PS 0 or 1), and have proper organ function. People with certain lung conditions, other cancers within the last three years, brain metastases, or specific genetic mutations are not eligible.

Inclusion Criteria

My tumor's genetic changes were analyzed using a certified liquid biopsy test.

Other protocol defined inclusion criteria could apply

My previous treatment with anti-PD-(L)1 therapy showed stable disease or improvement.

+5 more

Exclusion Criteria

I have had pneumonitis treated with steroids or currently have lung disease.

I have had another type of cancer within the last 3 years.

My cancer has specific changes in the EGFR or ALK genes.

+2 more

Participant Groups

The study tests M1774 combined with Cemiplimab on patients whose nsqNSCLC has progressed despite prior treatments. It's an open-label trial meaning everyone knows what treatment they're getting. The goal is to see how well this combo works in terms of safety and effectiveness while also studying how the body processes these drugs.

5Treatment groups

Experimental Treatment

Group I: Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1bExperimental Treatment2 Interventions

Group II: Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1bExperimental Treatment2 Interventions

Group III: Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1bExperimental Treatment2 Interventions

Group IV: Dosing Regimen 2 (Phase 1b): M1774 + CemiplimabExperimental Treatment2 Interventions

Group V: Dosing Regimen 1 (Phase 1b): M1774 + CemiplimabExperimental Treatment2 Interventions

Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:

🇪🇺 Approved in European Union as Libtayo for: