22931 - A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors.

Studio Clinico

Patologia: Carcinoma del pancreas esocrino, Neoplasie cerebrali, Neoplasie del polmone, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1, II

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Participant must be ≥ 18 years old of age, or the legal age of consent in the jurisdiction of the country in which the study takes place, at the time of signing the informed consent.
- At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
- Homozygous MTAP-deletion identified through molecular testing from a locally certified laboratory.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Criteri di esclusione: 

- Previous additional cancer other than the one evaluated in this study within the past 2 years except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, localized prostate cancer or other tumors that in the opinion of the investigator, are considered cured or not immediately life-threatening, and will not interfere with the scientific goals of this study.
- A marked prolongation of QT/QTc interval at screening (e.g., repeated demonstration of a QTc interval >450 ms). Participants with permanent pacemakers (i.e., a paced rhythm) may be eligible based on the investigator's clinical assessment and discretion.

- Cardiac history comprising:
   - History of congestive heart failure Class >II according to the New York Heart Association Functional Classification.
   - Myocardial infarction less than 6 months before the start of study intervention.
   - Serious cardiac arrhythmias requiring treatment or any clinically important abnormalities in rhythm, conduction or morphology on resting ECG with the exception of atrial fibrillation which is well-controlled and requires only digoxin or beta blockers.
- Unstable angina within 4 weeks before start of study intervention.

Trattamento sperimentale: 

BAY 3713372

Trattamento di controllo: 

 - 

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2025-520623-24-00 - NCT06914128

Data di inserimento: 07.07.2026

Promotore

Bayer

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: -