A Study of HS-20089 in Patients With Advanced Solid Tumors

This is a Phase 1a/1b open-label, multicenter study with dose escalation and dose expansion cohorts to evaluate the safety, tolerability, PK and preliminary efficacy of HS-20089 in patients with advanced solid tumors.

The Dose Escalation will include an initial accelerated titration design followed by a Bayesian optimal interval (BOIN) design. Enrollment into Dose Expansion will begin after identification of the MTD and/or MAD in Phase 1a. In Phase 1b, preliminary efficacy will be evaluated in planned expansion cohorts that include patients with specific tumor types that are B7-H4+ advanced solid tumors.

Inclusion criteria

• Men or women aged more than or equal to (≥) 18 years
• Advanced solid tumor patients confirmed by histology or cytology for who that standard treatment is invalid, unavailable or intolerable
• Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required)
• ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks
• Estimated life expectancy greater than (>) 12 weeks
• Females should be using adequate contraceptive measures throughout the study; should not be breastfeeding at the time of screening, during the study and until 3 months after completion of the study; and must have evidence of non-childbearing potential
• Sign Informed Consent Form

Exclusion criteria

• Treatment with any of the following:

• Previous or current treatment with drugs targeting B7-H4
• Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 28 days of the first dose of study drug
• Radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.
• Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
• Known and untreated, or active central nervous system metastases.
• Existing abnormal CTCAE≥grade 2 resulted from previous treatment
• History of other malignancy
• Inadequate bone marrow reserve or organ function
• Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured, Known history of HIV
• History of hypersensitivity to any active or inactive ingredient of HS-20089.
• Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
• Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.