Pan SOHO - A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations (22752).

Studio Clinico

Patologia: Carcinoma della vescica, Tumori del colon retto, Tumori delle vie biliari, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer; bladder and urothelial tract cancer; cervical cancer; endometrial cancer; other solid tumor cancer, excluding NSCLC)
- Participant must be ≥18 years of age or over the legal age of consent
- Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments
- Documented activating HER2 mutation
- At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria.

Criteri di esclusione: 

- Primary diagnosis of non-small cell lung cancer (NSCLC)
- Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)
- Active brain metastases
- Uncontrolled, severe, intercurrent illness.

Trattamento sperimentale: 

BAY2927088

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-517419-62-00

Data di inserimento: 17.06.2025

Promotore

Bayer

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na