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HFB-200301-01 - A Phase 1a/1b, Open-Label, Multi-Center, Dose Escalation and Expansion Study of HFB200301 (TNFR2 Agonist Antibody) as a Single Agent and in Combination With Tislelizumab (Anti-PD-1 Antibody) in Adult Patients With Advanced Solid Tumors

Studio Clinico

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: 


Centri partecipanti

Nord Italia

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

Informazioni Generali


Numero di iscrizione a registro: 2021-006231-25

Data di inserimento: 28.02.2024


HiFiBiO Therapeutics

Principal Investigator ITALIA

Riferimento: Dr. info non applicabile (nuovo Regolamento Europeo)

Telefono: 00000


Localita: na


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