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INCA33890-101 - A Phase 1, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

Studio Clinico

Patologia: Carcinoma del pancreas esocrino, Carcinoma della vescica, Melanoma, Mesotelioma, Neoplasie della mammella, Neoplasie del polmone, Neoplasie dello stomaco, Tumori del colon retto, Tumori dell’esofago, Tumori del rene, Tumori dell’utero, Tumori dell’ovaio, Tumori della testa e del collo, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1,

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

• ≥18 years old
• Histologically or cytologically confirmed advanced or metastatic malignancies
• Participants must have experienced disease progression after treatment with available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit, or who are intolerant to, or ineligible for standard treatment. Prior anti-PD-(L)1 therapy should not have been discontinued because of intolerance.
• ECOG performance status score of 0 or 1.
• Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory for Part 1b cohorts only.
• Presence of measurable disease according to RECIST v1.1

Criteri di esclusione: 

• Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years
• Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy
• Has active autoimmune disease requiring systemic immunosuppression with corticosteroids Brain or CNS metastases untreated or that have progressed
• History of organ transplant, including allogeneic stem cell transplantation.
• Received more than 4 prior anticancer regimen(s) for advanced or metastatic disease.
• History of clinically significant or uncontrolled cardiac disease
• Active HBV (or at risk of activation), active HCV, or HIV positive
• Is on chronic systemic steroids (> 10 mg/day of prednisone or equivalent).
• Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
• Participants that have been initiated on or had modifications in anticoagulation therapies within the last 3 months prior to first dose of treatment.
• Significant concurrent, uncontrolled medical condition, eg:
    - Cardiovascular: Participants with known vasculitis, aneurisms, and other vascular malformations of clinical significance
• Participants with adequate laboratory values within the protocol defined ranges.

Trattamento sperimentale: 

INCA33890

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

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

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

 

AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR
Centro Ricerche Cliniche (CRC) - Policlinico G.B. Rossi

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2022-502456-31-00

Data di inserimento: 14.02.2024

Promotore

Incyte Corporation

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile (nuovo regolamento Europeo)

Telefono: 00000

Email: nd@nd.it

Localita: nd

 

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