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
The purpose of this study is to test the safety and tolerability of HFB200301 as a single agent and in combination with tislelizumab in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses of HFB200301 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200301 as a single agent or combination therapy is determined. During the expansion part, participants will take the dose of HFB200301 as a monotherapy or in combination with tislelizumab that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.
• 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