MK-1022-011 - A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers

Studio Clinico

Patologia: Epatocarcinoma, Tumori del colon retto, Tumori delle vie biliari

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1, II

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

The main inclusion criteria include but are not limited to the following:

- Has one of the following cancers:
    - Unresectable or metastatic colorectal cancer.
    - Advanced and/or unresectable biliary tract cancer (BTC)
    - Hepatocellular carcinoma (HCC) not amenable to locoregional therapy
- Has received prior therapy for the cancer.
- Has recovered from any side effects due to previous cancer treatment.

Criteri di esclusione: 

The main exclusion criteria include but are not limited to the following:

- Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
- Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
- Has clinically significant corneal disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.

Trattamento sperimentale: 

Patritumab deruxtecan

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-512442-41

Data di inserimento: 17.03.2025

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na