Clinical Trial Finder

Inclusion Criteria:

• - 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.

Exclusion Criteria:

• - 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.

This is a Phase 1a/1b, first in human, open-label, dose escalation and expansion study in adults with advanced cancers. The study will comprise of. 1. A Screening Period. 2. A Treatment Period during which participants will receive the study drug on the first day of each cycle. 3. A Follow-up Period

Arms

Experimental: Dose Escalation - HFB200301 monotherapy

Participants will be administered HFB200301 at dose levels 1-5 as an intravenous infusion to determine the Recommended Dose for Expansion (RDE).

Experimental: Dose Escalation - HFB200301 in combination with tislelizumab

Participants will be administered HFB200301 at dose levels 1-4 in combination with one dose level of tislelizumab as an intravenous infusion to determine the combination Recommended Dose for Expansion (RDE).

Experimental: Dose Expansion - HFB200301 monotherapy

Participants will be administered HFB200301 at monotherapy RDE as an intravenous infusion.

Experimental: Dose Expansion - HFB200301 in combination with tislelizumab

Participations will be administered HFB200301 in combination with tislelizumab at combination RDE as an intravenous infusion.

Interventions

Drug: - HFB200301

Participants will be administered HFB200301 as described in the experimental arm.

Drug: - Tislelizumab

Participants will be administered tislelizumab as described in the experimental arm.