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ACTIVE NOT RECRUITING

NCT05882734

PHASE1/PHASE2

Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

Summary

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..

Official title: An Open Label, Multicenter, Phase 1b/2a Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of the ATR Inhibitor M1774 in Combination With Cemiplimab in Participants With Non-Squamous Non-Small Cell Lung Cancer That Has Progressed on Prior Anti-PD-(L)1 and Platinum-based Therapies (DDRiver NSCLC 322)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-09-13

Completion Date

2026-03-30

Last Updated

2026-02-17

Healthy Volunteers

Conditions

Non-Small Cell Lung Cancer

Interventions

DRUG

M1774

In Phase 1b, M1774 will be administered as dosing regimen 1 or dosing regimen 2 until disease progression, death discontinuation criteria or any other reason. The selected dosing regimen of M1774 will be administered in all arms of Phase 2a.

DRUG

Cemiplimab

Cemiplimab will be administered as an intravenous infusion every 3 weeks in all arms of Phase 1b and Phase 2a until disease progression, death discontinuation criteria or any other reason.

Inclusion Criteria: * Participants who are diagnosed with nsqNSCLC histologically or cytologically confirmed * Participants with Radiologically confirmed/documented disease progression during or after the following systemic therapies (all required): * At most, 1 line of anti-PD-(L)1 therapy for locally advanced or metastatic disease. Rechallenge with the same anti-PD-(L)1 for disease considered sensitive to anti-PD-(L)1 therapy (e.g. after a treatment break) is considered 1 line * Platinum-based therapy for locally advanced or metastatic disease, given in combination or sequentially with anti-PD-(L)1 therapy. Participants who received adjuvant platinum-based therapy meet this criterion if disease progression occurred within 6 months from the last dose that the participant received that therapy. No additional cytotoxic therapies after progression on platinum-based therapy are allowed * Prior best overall response of stable disease or better with anti-PD-(L)1 therapy * Disease progression must have occurred while the participant has been receiving anti-PD-(L)1 therapy or within 16 weeks of the last dose of anti-PD-(L)1 therapy * Participants with Measurable disease per RECIST v1.1 * Participants with Eastern Cooperative Oncology Group (ECOG) PS 0 or 1 * Adequate hematological, hepatic, and renal function as defined in the protocol. * Phase 2a part only: central liquid biopsy analysis of tumor molecular alterations with an assay with appropriate regulatory status * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Participants with tumors harboring actionable epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic aberrations. Participants with tumors with other actionable aberrations are eligible and allowed to have received up to 1 line of available targeted therapy * Participants with history of additional malignancy within 3 years before the date of enrollment. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence of the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years * Participants with known brain metastases, unless clinically stable * Participant with history of (noninfectious) pneumonitis that required systemic corticosteroids or current pneumonitis/interstitial lung disease * Other protocol defined exclusion criteria could apply

Locations (54)

UCLA Hematology and Oncology - Santa Monica

Santa Monica, California, United States

UPMC Cancer Center

Pittsburgh, Pennsylvania, United States

Tennessee Cancer Specialists - Biomedical Research

Knoxville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Millennium Research & Clinical Development

Houston, Texas, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Institut Jules Bordet - Department of Institut Jules Bordet'

Anderlecht, Belgium

UZA - Oncology

Edegem, Belgium

Jessa Ziekenhuis Hospital

Hasselt, Belgium

Universitair Ziekenhuis Brussel - UZB

Jette, Belgium

UZ Leuven

Leuven, Belgium

CHU de Liège - PARENT

Liège, Belgium

CHU Angers - Hôpital Larrey - Service de Pneumologie

Angers, France

Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie

Créteil, France

CHU Limoges - Hôpital Dupuytren - Unite d'Oncologie Thoracique et Cutanée

Limoges, France

Hôpital de la Timone - CPCEM CIC - Bat F 1er étage

Marseille, France

Hopital Arnaud de Villeneuve - Service de Pneumologie-Addictologie

Montpellier, France

Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Unité d'Explorations Fonctionnelles Respiratoires

Pessac, France

ICO - Site René Gauducheau - Service d'Oncologie medicale

Saint-Herblain, France

Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik und Poliklinik III

Giessen, Germany

Universitaetsklinikum Leipzig AoeR - Med. Klinik u. Poliklinik I - Abt. Pneumologie

Leipzig, Germany

Sana Klinikum Offenbach GmbH - Medizinische Klinik IV

Offenbach, Germany

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - U.O. Oncologia Medica

Bologna, Italy

IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica

Milan, Italy

Ospedale San Raffaele - U.O. di Oncologia Medica

Milan, Italy

Istituto Nazionale Tumori Fondazione G. Pascale - Medical Oncology Thoraco-Pulmonary Department

Naples, Italy

Istituto Nazionale Tumori Regina Elena IRCCS - S.C. Oncologia Medica B

Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

Rome, Italy

Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia

Rozzano, Italy

National Cancer Center Hospital

Chūōku, Japan

Kansai Medical University Hospital

Hirakata-shi, Japan

National Cancer Center Hospital East

Kashiwa-shi, Japan

Cancer Institute Hospital of JFCR

Kōtoku, Japan

Kurume University Hospital

Kurume-shi, Japan

Aichi Cancer Center Hospital

Nagoya, Japan

Kindai University Hospital

Osakasayama-shi, Japan

Kanagawa Cancer Center

Yokohama, Japan

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Severance Hospital, Yonsei University Health System - Division of Infectious Diseases

Seoul, South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Hospital Clinic de Barcelona - Servicio de Oncologia

Barcelona, Spain

Hospital Universitari Vall d'Hebron - Oncology Dept.

Barcelona, Spain

Hospital Universitario Reina Sofia - Dept of Oncology

Córdoba, Spain

Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

Madrid, Spain

Hospital Universitario 12 de Octubre - Servicio de Oncologia

Madrid, Spain

Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

Madrid, Spain

Hospital Universitario La Paz - Oncology Department

Madrid, Spain

Hospital Universitario Ramon y Cajal - Servicio de Oncologia

Madrid, Spain

Hospital Regional Universitario de Malaga - Oncology Dept

Málaga, Spain

Hospital Universitario Nuestra Señora de Valme - Servicio de Oncologia

Seville, Spain

Hospital Universitario Virgen del Rocio - Oncology Service

Seville, Spain

Hospital Universitario Virgen Macarena - Oncology Service

Seville, Spain

Hospital Universitari i Politecnic La Fe - Oncology Department

Valencia, Spain

Clinical Research Directory

Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (54)