Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors

Key Inclusion Criteria:

• Have a Histologically or cytologically confirmed non-CNS solid tumor that ismetastatic or unresectable and for whom there is no available standard therapy.

• PD-L1 positive expression (Tumor Proportion Score ≥1% or Combined Positive Score ≥1).

• Have at least one lesion, not previously irradiated that can be accurately measuredper RECIST version 1.1.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Age of 18 years or older (or country's legal age of majority if the legal age was >18 years)

• Adequate Hematologic and liver function.

Key Exclusion Criteria:

• Has received prior therapy with an anti-4-1BB(CD137) agent.

• Known active CNS metastases and/or carcinomatous meningitis.

• Known additional malignancy that is progressing or has required active treatment.

• History of chronic liver disease or evidence of hepatic cirrhosis.

• History of severe toxicities associated with a prior immunotherapy.

• Has ongoing or suspected autoimmune disease.

• Known active and clinically significant bacterial, fungal or viral infectionincluding known human immunodeficiency virus (HIV) or acquired immunodeficiencysyndrome (AIDS)-related illness, immunocompromised patients.