Patologia: Carcinoma del pancreas esocrino, Carcinoma della prostata, Carcinoma della vescica, Epatocarcinoma, Neoplasie della mammella, Neoplasie del retto e ano, Neoplasie del polmone, Neoplasie dello stomaco, Tumori del colon retto, Tumori dell’esofago, Tumori dell’ovaio, Tumori della testa e del collo
Fase di studio: 1,
Linee di trattamento: Prima linea, Seconda linea
Criteri di inclusione:
• Ability to comprehend and willingness to sign an ICF.
• Willing and able to conform to and comply with all Protocol requirements.
• Histologically or cytologically confirmed advanced/metastatic SCCHN, NSCLC, ovarian cancer, TNBC, CRPC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC) that progressed after treatment with available therapies (including anti PD-(L)1 therapy (if applicable).
• Willingness to undergo pre- and on-treatment tumor biopsy.
• Have CD8 T-cell-positive tumors.
• Presence of measurable disease according to RECIST v1.1.
• ECOG performance status 0 to 1.
• Life expectancy > 12 weeks.
• Willingness to avoid pregnancy or fathering children based.
• Acceptable laboratory parameters.
Criteri di esclusione:
• Clinically significant cardiac disease.
• Known or active CNS metastases and/or carcinomatous meningitis.
• Active or inactive autoimmune disease or syndrome that required systemic treatment in the past 2 years or receiving systemic therapy for an autoimmune or inflammatory disease..
• Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses > 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment.
• Known additional malignancy that is progressing or requires active treatment,or history of other malignancy within 2 years of the first dose of study treatment.
• Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment.
• Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis.
• Immune-related toxicity during prior immune therapy for which permanent discontinuation of therapy is recommended, or any immune-related toxicity requiring intensive or prolonged immunosuppression to manage.
• Any prior chemotherapy, biological therapy, or targeted therapy to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
• Any prior radiation therapy within 28 days before the first dose of study treatment.
• Undergoing treatment with another investigational medication or having been treated with an investigational medication within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
• Concomitant treatment with strong CYP3A4 inhibitors or inducers.
• Receipt of a live vaccine within 30 days of the first dose of study treatment.
• Infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week of the first dose of study treatment.
• Evidence of HBV or HCV infection or risk of reactivation.
• Known history of HIV (HIV 1/2 antibodies).
• History of organ transplant, including allogeneic stem-cell transplantation.
• Known hypersensitivity or severe reaction to any component of study drug(s) or formulation components.
• Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
• Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.
• Any condition that would, in the investigator's judgment, interfere with full participation in the study,pose a significant risk to the participant; or interfere with interpretation of study data.
Trattamento di controllo:
Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI
A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO
NB: Arruolamento pazienti non ancora attivo
AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
NB: Arruolamento pazienti non ancora attivo
Numero di iscrizione a registro: 2020-002921-27
Data di inserimento: 12.09.2022
Istituto Clinico Humanitas Rozzano (MI)
Riferimento: Dr. Info non disponibile
Localita: Rozzano (MI)