Patologia: Melanoma, Mesotelioma, Neoplasie del polmone, Neoplasie dello stomaco, Tumore del testicolo, Tumori del rene, Tumori dell’utero, Tumori della testa e del collo, Altre neoplasie
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: No
Fase di studio: 1, I A, I B
Linee di trattamento: Seconda linea, Terza/N linea
Criteri di inclusione:
- Previously received the following lines of systemic therapy for the advanced/metastatic disease:
- Gastric cancer: at least 2 lines of therapy
- Renal cell carcinoma: at least 2 lines of therapy
- Melanoma:
- BRAF V600E mutant: must have received at least 2 lines of therapy
- BRAF V600E wild type: must have received at least 1 line of therapy
- Sarcoma: at least 1 line of therapy
- Testicular germ cell tumor: at least 2 lines of therapy
- Cervical cancer: at least 2 lines of therapy
- Mesothelioma: at least 2 lines of therapy
- Non-small cell lung cancer: at least 2 lines of therapy
- Head and neck squamous cell carcinoma: at least 2 lines of therapy
- Suitable site to biopsy at pre-treatment and on-treatment
- Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST (mRECIST) for mesothelioma
- Eastern Cooperative Oncology Group performance status of 0 or 1.
Criteri di esclusione:
- Systemic anti-cancer therapy within 2 weeks prior to start of study drug or within 4 weeks for immune-oncologic therapy
- For soft tissue sarcoma and testicular germ cell tumor patients only: prior immune therapy
- Therapeutic radiation therapy within the past 2 weeks
- Prior exposure to agents targeting the Tumor Necrosis Factor Receptor type 2 (TNFR2) receptor
- Active autoimmune disease requiring systemic treatment in the previous 2 years
- Systemic steroid therapy (>10 mg/day of prednisone or equivalent) or any immune suppressive therapy ≤ 14 days before first dose
- Persisting toxicity of ≥Grade 2 (≥Grade 1 for diarrhea) relating to prior anti cancer therapy with the following exceptions:
- All grades of alopecia are acceptable
- Endocrine dysfunction on replacement therapy is acceptable
- Severe or unstable medical condition, including uncontrolled diabetes, coagulopathy, or unstable psychiatric condition
- Major surgery within 4 weeks of the first dose of study drug
- History or presence of drug or non-drug induced interstitial lung disease or pneumonitis ≥Grade 2. For combination only: non-small cell lung cancer patients, mesothelioma or patients with significantly impaired pulmonary function or who require supplemental oxygen at baseline must undergo an assessment of pulmonary function at screening
- History of allergic reactions, immune related reactions, or cytokine release syndrome (CRS) attributed to compounds of similar chemical or biologic composition to monoclonal antibodies or any excipient of HFB200301
- Using sensitive substrates of major cytochrome P450 (CYP450) enzymes
- Known active malignancy, with the exception of the specific cancer under investigation in this trial, that required treatment within the previous 2 years
- For combination only:
- Prior randomization in a tislelizumab study regardless of the treatment arm, until the primary and key secondary endpoints of the study have read out
- Hypersensitivity to tislelizumab or any of its excipients.
Trattamento sperimentale:
HFB200301 monotherapy
HFB200301 in combination with tislelizumab.
Trattamento di controllo:
NA
AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR
Centro Ricerche Cliniche Verona - Policlinico G.B. Rossi
Riferimento: Dr.ssa Jessica Menis
Telefono: 0458128132
Email: jessica.menis@aovr.veneto.it
Numero di iscrizione a registro: 2021-006231-25
Data di inserimento: 28.02.2024
HiFiBiO Therapeutics
Riferimento: Dr. info non applicabile (nuovo Regolamento Europeo)
Telefono: 00000
Email: na@na.it
Localita: na