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MK-9999-02A - A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers

Studio Clinico

Patologia: Carcinoma del pancreas esocrino, 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 or metastatic pancreatic ductal adenocarcinoma (PDAC)
    - Advanced and/or unresectable biliary tract cancer (BTC)
- 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:

- History of severe eye disease
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung diseas.

Trattamento sperimentale: 

BIOLOGICAL: Sacituzumab tirumotecan
DRUG: Fluorouracil (5-FU)
DRUG: Leucovorin (LV) or levoleucovorin
DRUG: Rescue medication
DRUG: Supportive care measures

Trattamento di controllo: 

-

Centri partecipanti

Nord Italia

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
SC Oncologia Medica 1

Riferimento: Dr. Filippo Pietrantonio
Telefono: 0223903822
Email: filippo.pietrantonio@istitutotumori.mi.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-508703-21 - NCT06428409

Data di inserimento: 23.09.2024

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na

 

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