Clinical trial • Phase II • Oncology

2-[4-[4-(AMINOMETHYL)-1-OXO-2H-PHTHALAZIN-6-YL]-2-METHYLPYRAZOL-3-YL]-4-CHLORO-6-CYCLOPROPYLOXY-3-FLUOROBENZONITRILE for Non-small cell lung cancer

Phase II trial of 2-[4-[4-(AMINOMETHYL)-1-OXO-2H-PHTHALAZIN-6-YL]-2-METHYLPYRAZOL-3-YL]-4-CHLORO-6-CYCLOPROPYLOXY-3-FLUOROBENZONITRILE for Non-small cell…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
11-04-2025
First CTIS Authorization Date
01-08-2025

Trial design

Randomised, open-label, none/not specified-controlled Phase II trial in France, Italy, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
None/Not specified
Biomarker Stratified
True, biomarker: homozygous MTAP deletion (eligibility criterion)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
56

Eligibility

Recruits 56 Participants must be ≥ 18 years of age (or the legal age of consent in the jurisdiction) at the time of signing the ICF; vulnerable populations not selected (isVulnerablePopulationSelected=false); consent is provided by the participant (no assent of minors described)..

Vulnerable Population
Participants must be ≥ 18 years of age (or the legal age of consent in the jurisdiction) at the time of signing the ICF; vulnerable populations not selected (isVulnerablePopulationSelected=false); consent is provided by the participant (no assent of minors described).

Inclusion criteria

  • {"criterion_text":"- Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion detected in tumor tissue."}
  • {"criterion_text":"- Advanced or metastatic NSCLC not amenable to curative therapies after progression on prior therapies at the time of enrollment (based on the American Joint Committee on Cancer, Ninth Edition)."}
  • {"criterion_text":"- At least 1 measurable lesion as per RECIST v1.1."}
  • {"criterion_text":"- Documented radiographic disease progression on or after the most recent line of treatment."}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1"}
  • {"criterion_text":"- Participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF"}
  • {"criterion_text":"- Capability to swallow."}

Exclusion criteria

  • {"criterion_text":"- Active brain metastases or carcinomatous meningitis."}
  • {"criterion_text":"- Prior treatment with a PRMT5 or MAT2A inhibitor."}
  • {"criterion_text":"- Known severe hypersensitivity to study treatment and/or any of its excipients."}
  • {"criterion_text":"- Other protocol-defined inclusion/exclusion criteria apply."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1","definition_or_measurement_approach":"Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1"}

Secondary endpoints

  • {"endpoint_text":"- Number of participants who achieve disease control (DC) as assessed by RECIST v1.1","definition_or_measurement_approach":"Assessed by RECIST v1.1"}
  • {"endpoint_text":"- Duration of response (DOR) as assessed by RECIST v1.1","definition_or_measurement_approach":"Assessed by RECIST v1.1"}
  • {"endpoint_text":"- Progression-free survival (PFS) as assessed by RECIST v1.1","definition_or_measurement_approach":"Assessed by RECIST v1.1"}
  • {"endpoint_text":"- Time to objective response (TTOR) as assessed by RECIST v1.1","definition_or_measurement_approach":"Assessed by RECIST v1.1"}
  • {"endpoint_text":"- Number of participants with adverse events (AE)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of participants with Serious AEs (SAEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of participants with AEs leading to dose interruption, reduction, or discontinuation","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of participants who achieve Objective Response (OR) as assessed by RECIST v1.1","definition_or_measurement_approach":"Assessed by RECIST v1.1"}
  • {"endpoint_text":"- Overall Survival","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score and symptom score","definition_or_measurement_approach":"Assessed using the NSCLC-SAQ total and symptom scores"}
  • {"endpoint_text":"- Change from baseline in cancer-related symptoms and health-related quality of life as assessed by the EORTC-QLQ-F17 quality-of-life (QoL) functional scale score","definition_or_measurement_approach":"Assessed using the EORTC-QLQ-F17 functional scale score"}

Recruitment

Digital Remote Recruitment
True, includes electronic study-related communications, eCOA/PRO (Signant Health Global LLC), electronic payments and travel arrangements to patients (Greenphire LLC), and platform/operations support (Accenture Solutions Private Limited, Medidata Solutions Inc.) as listed in third-party duties.
Planned Sample Size
56
Recruitment Window Months
77
Consent Approach
Informed consent to be provided by the participant; participants must be ≥ 18 years of age (or the legal age of consent in the jurisdiction) at time of signing the ICF. Subject information and informed consent forms are available in multiple country-specific languages (documents listed for FR, IT, ES, PL, DE, EN and others).

Methods

  • Patient recruitment (explicitly listed as duty for Massive Bio Inc.)
  • Electronic study-related communications and electronic payments/travel arrangements to patients (provided by Greenphire LLC)
  • Central laboratory and routine clinical pathology testing (Labcorp Central Laboratory Services SARL)
  • Site payments (IQVIA Inc.)

Geography

Total Number Of Sites
39
Total Number Of Participants
74

France

Earliest CTIS Part Ii Submission Date
18-07-2025
Latest Decision Or Authorization Date
22-02-2026
Processing Time Days
247
Number Of Sites
8
Number Of Participants
14

Sites

Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Oncologie thoracique
Principal Investigator Name
Denis MORO-SIBILOT
Principal Investigator Email
Dmoro.pneumo@chu-grenoble.fr
Contact Person Name
Denis MORO-SIBILOT
Contact Person Email
Dmoro.pneumo@chu-grenoble.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pneumologie, Oncologie thoracique
Principal Investigator Name
Jacques CADRANEL
Principal Investigator Email
jacques.cadranel@aphp.fr
Contact Person Name
Jacques CADRANEL
Contact Person Email
jacques.cadranel@aphp.fr
Site Name
CHRU De Nancy
Department Name
Pneumologie
Principal Investigator Name
Bertrand MENNECIER
Principal Investigator Email
b.mennecier@chru-nancy.fr
Contact Person Name
Bertrand MENNECIER
Contact Person Email
b.mennecier@chru-nancy.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pneumologie, Oncologie thoracique
Principal Investigator Name
Marie WISLEZ
Principal Investigator Email
marie.wislez@aphp.fr
Contact Person Name
Marie WISLEZ
Contact Person Email
marie.wislez@aphp.fr
Site Name
Institut Curie
Department Name
Pneumologie
Principal Investigator Name
Nicolas GIRARD
Principal Investigator Email
nicolas.girard2@curie.fr
Contact Person Name
Nicolas GIRARD
Contact Person Email
nicolas.girard2@curie.fr
Site Name
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Department Name
Oncologie
Principal Investigator Name
Carole HELISSEY DANIS
Principal Investigator Email
chelissey@ghpsj.fr
Contact Person Name
Carole HELISSEY DANIS
Contact Person Email
chelissey@ghpsj.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Oncologie médicale
Principal Investigator Name
Elvire PONS-TOSTIVINT
Principal Investigator Email
elvire.pons@chu-nantes.fr
Contact Person Name
Elvire PONS-TOSTIVINT
Contact Person Email
elvire.pons@chu-nantes.fr
Site Name
Hospices Civils De Lyon
Department Name
Pneumologie
Principal Investigator Name
Michael DURUISSEAUX
Principal Investigator Email
michael.duruisseaux@chu-lyon.fr
Contact Person Name
Michael DURUISSEAUX

Italy

Earliest CTIS Part Ii Submission Date
11-07-2025
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
301
Number Of Sites
7
Number Of Participants
13

Sites

Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Oncology
Principal Investigator Name
Diego Luigi Cortinovis
Principal Investigator Email
diegoluigi.cortinovis@irccs-sangerardo.it
Contact Person Name
Diego Luigi Cortinovis
Site Name
Istituto Oncologico Veneto
Department Name
Oncology
Principal Investigator Name
Giulia Pasello
Principal Investigator Email
giulia.pasello@iov.veneto.it
Contact Person Name
Giulia Pasello
Contact Person Email
giulia.pasello@iov.veneto.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Oncology
Principal Investigator Name
Giulio Cerea
Principal Investigator Email
giulio.cerea@ospedaleniguarda.it
Contact Person Name
Giulio Cerea
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Thoracopulmonary
Principal Investigator Name
Alessandro Morabito
Principal Investigator Email
a.morabito@istitutotumori.na.it
Contact Person Name
Alessandro Morabito
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Oncology and Hematology
Principal Investigator Name
Francesco Gelsomino
Principal Investigator Email
francesco_gelsomino@aosp.bo.it
Contact Person Name
Francesco Gelsomino
Contact Person Email
francesco_gelsomino@aosp.bo.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncology
Principal Investigator Name
Claudia Proto
Principal Investigator Email
claudia.proto@istitutotumori.mi.it
Contact Person Name
Claudia Proto
Site Name
Azienda Ospediera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Oncology and Hematology
Principal Investigator Name
Carminia Maria Della Corte
Principal Investigator Email
carminiamaria.dellacorte@unicampania.it
Contact Person Name
Carminia Maria Della Corte

Spain

Earliest CTIS Part Ii Submission Date
14-07-2025
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
303
Number Of Sites
8
Number Of Participants
15

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Principal Investigator Name
Reyes Bernabé
Principal Investigator Email
xxx.xxx@xxx.es
Contact Person Name
Reyes Bernabé
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Luis Paz-Ares
Principal Investigator Email
xxx.xxx@xxx.es
Contact Person Name
Luis Paz-Ares
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Principal Investigator Name
Oscar Juan Vidal
Principal Investigator Email
juan_osc@gva.es
Contact Person Name
Giovanni/ Juan Osc (listed contact)
Contact Person Email
juan_osc@gva.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Principal Investigator Name
Maria Eugenia Olmedo Garcia
Principal Investigator Email
xxx.xxx@xxx.es
Contact Person Name
Maria Eugenia Olmedo Garcia
Contact Person Email
xxx.xxx@xxx.es
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Principal Investigator Name
Javier De Castro Carpeno
Principal Investigator Email
javier.decastro@salud.madrid.org
Contact Person Name
Javier De Castro Carpeno
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Enriqueta Felip Font
Principal Investigator Email
efelip@vhio.net
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Principal Investigator Name
Ernest Nadal Alforja
Principal Investigator Email
esnadal@iconcologia.net
Contact Person Name
Ernest Nadal Alforja
Contact Person Email
esnadal@iconcologia.net
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Principal Investigator Name
Manuel Cobo-Dols
Principal Investigator Email
xxx.xxx@xxx.es
Contact Person Name
Manuel Cobo-Dols
Contact Person Email
xxx.xxx@xxx.es

Poland

Earliest CTIS Part Ii Submission Date
14-07-2025
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
301
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Department Name
Poradnia oknologiczna
Principal Investigator Name
Renata Biernacka
Principal Investigator Email
r.biernacka@szpitalonkologiczny.pl
Contact Person Name
Renata Biernacka
Site Name
Szpital Specjalistyczny W Prabutach Sp. z o.o.
Department Name
Oddział Pulmonologii
Principal Investigator Name
Anna Lowczak
Principal Investigator Email
onkoania@gazeta.pl
Contact Person Name
Anna Lowczak
Contact Person Email
onkoania@gazeta.pl

Sweden

Earliest CTIS Part Ii Submission Date
14-07-2025
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
302
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Karolinska University Hospital
Department Name
ME Huvud-, Hals-, Lunga- och Hudcancer
Principal Investigator Name
Luigi De Petris
Principal Investigator Email
luigi.depetris@regionstockholm.se
Contact Person Name
Luigi De Petris
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Verksamhet onkologi, Blå stråket 2
Principal Investigator Name
Andreas Hallqvist
Principal Investigator Email
andreas.hallqvist@vgregion.se
Contact Person Name
Andreas Hallqvist
Contact Person Email
andreas.hallqvist@vgregion.se

Romania

Earliest CTIS Part Ii Submission Date
24-10-2025
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
201
Number Of Sites
7
Number Of Participants
14

Sites

Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Oncology
Principal Investigator Name
Constantin Volovat
Principal Investigator Email
cvolovat@yahoo.com
Contact Person Name
Constantin Volovat
Contact Person Email
cvolovat@yahoo.com
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncology
Principal Investigator Name
Michael Schenker
Principal Investigator Email
mike_schenker@yahoo.com
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Centrul De Diagnostic Si Tratament Provita S.A.
Department Name
Oncology
Principal Investigator Name
Mircea Dediu
Principal Investigator Email
dr.mdediu@gmail.com
Contact Person Name
Mircea Dediu
Contact Person Email
dr.mdediu@gmail.com
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Oncology
Principal Investigator Name
Aurelia Alexandru
Principal Investigator Email
auralexandru@yahoo.com
Contact Person Name
Aurelia Alexandru
Contact Person Email
auralexandru@yahoo.com
Site Name
Institutul Regional De Oncologie Iasi
Department Name
Oncology
Principal Investigator Name
Dana Clement
Principal Investigator Email
dclement_6600@yahoo.com
Contact Person Name
Dana Clement
Contact Person Email
dclement_6600@yahoo.com
Site Name
Radiotherapy Center Cluj S.R.L.
Department Name
Oncology
Principal Investigator Name
Andrei Ungureanu
Principal Investigator Email
andrei.ungureanu@amethyst-radiotherapy.com
Contact Person Name
Andrei Ungureanu
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncology
Principal Investigator Name
Tudor Ciuleau
Principal Investigator Email
office@iocn.ro
Contact Person Name
Tudor Ciuleau
Contact Person Email
office@iocn.ro

Germany

Earliest CTIS Part Ii Submission Date
11-07-2025
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
304
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Interdisziplinäres Studienzentrum (ISZ) mit Ectu
Principal Investigator Name
Elisabeth Maria Goebeler
Principal Investigator Email
isz_koordination@ukw.de
Contact Person Name
Elisabeth Maria Goebeler
Contact Person Email
isz_koordination@ukw.de
Site Name
University Hospital Cologne AöR
Department Name
Innere Medizin I
Principal Investigator Name
Jürgen Wolf
Principal Investigator Email
juergen.wolf@uk-koeln.de
Contact Person Name
Jürgen Wolf
Contact Person Email
juergen.wolf@uk-koeln.de
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik II
Principal Investigator Name
Fabian Acker
Principal Investigator Email
acker@med.uni-frankfurt.de
Contact Person Name
Fabian Acker
Contact Person Email
acker@med.uni-frankfurt.de
Site Name
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Department Name
Klinik für Innere Medizin II - Pneumologie
Principal Investigator Name
Miriam Moeller
Principal Investigator Email
miriam.moeller@martha-maria.de
Contact Person Name
Miriam Moeller
Contact Person Email
miriam.moeller@martha-maria.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinischen Klinik und Poliklinik V
Principal Investigator Name
Diego Kauffmann-Guerrero
Contact Person Name
Diego Kauffmann-Guerrero

Sponsor

Primary sponsor

Full Name
Bristol-Myers Squibb Services Unlimited Company
Organisation Type
Pharmaceutical company
Country Of Registered Address
Ireland

Contract research organisations

Name
Iqvia Inc.
Responsibilities
site payments

Third parties

  • {"country":"United States","full_name":"Massive Bio Inc.","duties_or_roles":"Patient recruitment","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Routine clinical pathology testing, Clinical chemistry, Clinical haematology, Clinical microbiology, Central Laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations; Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Discovery Life Sciences Biomarker Services GmbH","duties_or_roles":"Speciality Biomarker Laboratory, Pathology/central confirmatory Mtap testing establishing eligibility for FFPE tumor samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements, electronic study-related communications to patients","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta Biosciences","duties_or_roles":"Speciality Biomarker Laboratory, IHC profiling for MTAP and SDMA","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long-term sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"PK analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"site payments","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc., Image collection, image analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Somalogic Operating Co. Inc.","duties_or_roles":"Proteomics","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"PRO/eCOA","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta Biosciences","duties_or_roles":"Speciality Biomarker Laboratory, IHC profiling for MTAP and SDMA","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MRTX1719 (BMS986504)
Active Substance
2-[4-[4-(AMINOMETHYL)-1-OXO-2H-PHTHALAZIN-6-YL]-2-METHYLPYRAZOL-3-YL]-4-CHLORO-6-CYCLOPROPYLOXY-3-FLUOROBENZONITRILE
Modality
Small molecule
Routes Of Administration
Oral
Route
ORAL

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