A Phase 1 Study of HS130 in Combination With Viagenpumatucel-L (HS110) in Patients With Solid Tumors

Inclusion Criteria

• Patients with metastatic or advanced, unresectable solid tumor who have progressed, or recurred following standard-of-care (SOC) therapies or are ineligible for safe and effective SOC therapies and for whom, in the opinion of the Investigator, experimental therapy with HS-130/HS-110 may be beneficial.
• Patients should have lesions that are safely accessible for biopsy and be willing to provide pre-treatment and on-treatment tissue biopsy. Fine-needle aspiration biopsy is not acceptable. Archival tumor tissue will be accepted in lieu of fresh biopsy at screening if sample was collected within 6-months from Cycle 1 Day 1, and the local pathologist confirms that an adequate amount of tissue/tumor cells exist to allow completion of all testing as outlined in the specimen collection manual.
• Age ≥ 18 years.
• Have an acceptable organ function:
• Albumin ≥ 2.5 g/dL.
• Total Bilirubin 35 mL/minute per the Cockcroft-Gault formula.
• Absolute neutrophil count ≥ 1,500/mm3.
• Hemoglobin ≥ 9 g/dL.
• Platelet count ≥ 100,000/mm3.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least three months.
• Patients, both females and males, of childbearing/reproductive potential must agree to use adequate contraception while included in the trial and for six months after the last treatment with HS-130 and/or HS-110.
• Patients must be willing and have the capacity to sign the informed consent form.

Exclusion Criteria

• Have clinically significant cardiac disease, including:
• Onset of unstable angina within 6 months of signing the Informed Consent Form (ICF).
• Acute myocardial infarction within 6 months of the signing the ICF.
• Known congestive heart failure (Grade III or IV as classified by the New York Heart Association); and/ or a known decreased cardiac ejection fraction (LVEF) of 2 years is allowed.
• Any other ongoing significant, uncontrolled medical condition as per Investigator discretion.
• Received a live vaccine within 30 days prior to first dose of study drug.
• Clinically significant active viral, bacterial or fungal infection requiring:
• Intravenous treatment with antimicrobial therapy completed less than two weeks prior to first dose, or
• Oral treatment with antimicrobial therapy completed less than one week prior to first dose.

Prophylactic treatment with antibiotics (e.g. for dental extractions) is allowed.

• Known positive serology for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C (except in cases of immunity after cured infection). Testing not required.
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the trial or evaluation of the trial result in the opinion of the Investigator.
• Women who are pregnant or breast feeding.