A Study of HFB301001 in Adult Patients With Advanced Solid Tumors

Inclusion Criteria:

Previously received the following lines of systemic therapy for the advanced/metastatic disease:

Soft tissue sarcoma: at least 1 line of therapy
Renal cell carcinoma: at least 2 lines of therapy;
Uterine carcinosarcoma: at least 1 line of therapy;
Hepatocellular carcinoma: at least 1 line of therapy
Head and neck squamous 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
Suitable site to biopsy at pre-treatment and on-treatment
Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-RECIST (iRECIST)
Eastern Cooperative Oncology Group performance status of 0 or 1.

Exclusion Criteria:

Systemic anti-cancer therapy within 2 weeks prior to start of study drug.
For soft tissue sarcoma only: prior immune therapy or immune agonist antibodies
For uterine carcinosarcoma patients only: prior immune therapy
Therapeutic radiation therapy within the past 2 weeks
Prior exposure to agents targeting the OX40 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.

Persisting toxicity of >Grade 1 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 2 weeks of the first dose of study drug;
History or presence of drug or non-drug induced interstitial lung disease or pneumonitis ≥Grade 2;
History of allergic reactions attributed to compounds of similar chemical or biologic composition to monoclonal antibodies or any excipient of HFB301001;
Known active malignancy, with the exception of the specific cancer under investigation in this trial, that required treatment within the previous 2 years.