MK-1084-014 - A Phase 2, Open-Label, Multicenter, Tumor-agnostic Study of MK-1084 as Monotherapy and in Combination With Cetuximab, in Participants With KRAS G12C-Mutant, Advanced Solid Tumors (KANDLELIT-014)

Studio Clinico

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

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: II Randomizzato

Linee di trattamento: Seconda linea

Criteri di inclusione: 

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

- Has locally advanced unresectable or metastatic solid tumor malignancy other than colorectal cancer and has progressed on, or following, standard of care systemic treatment
- Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation.

Criteri di esclusione: 

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

- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors
- Has active infection, other than those permitted per protocol, requiring systemic therapy
- Has not adequately recovered from major surgery or has ongoing surgical complications.

Trattamento sperimentale: 

Calderasib

Calderasib + Cetuximab

Trattamento di controllo: 

-

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2025-521737-91-00

Data di inserimento: 27.03.2026

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: na