Tests HS-20093 in adults with relapsed or hard-to-treat bone and other sarcomas

Trial details

Who runs it

Hansoh BioMedical R&D Company

Trial code

NCT05830123

Record updated

23 August 2024

Original description

HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells.Read full original descriptionShow less

ARTEMIS-002: A Phase 2, Multicenter, Open-label Study of Intravenous Administration of HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas

HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells.

This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20093 as a monotherapy in patients with relapsed or refractory osteosarcoma and other sarcomas.

Inclusion: At least age of 18 years at screening; Patients with histologically confirmed relapsed or refractory osteosarcoma or other sarcomas who have progressed upon first-line systemic treatment; At least one measurable lesion according to RECIST 1.1; Agree to provide fresh or archival tumor tissue and peripheral blood samples; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1; Life expectancy >= 12 weeks; Men or women should be using adequate contraceptive measures throughout the study; Females subjects must not be pregnant at screening or have evidence of non-childbearing potential; Signed and dated Informed Consent Form.

Exclusion: Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity; Bleeding symptoms with apparent clinical significance or obvious bleeding tendency within 1 months prior to the first dose of HS-20093; Serious arteriovenous thrombosis events occurred within 3 months before the first dose; Severe infections occurred within 4 weeks before the first dose; Patients who have received continuous steroid treatment for more than 30 days within 30 days before the first dose, or need long-term (≥ 30 days) steroid treatment, or who have other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation; Previous history of serious neurological or mental disorders, including epilepsy, dementia or severe depression and any other status that may interfere in assessment; Vaccination or hypersensitivity of any level within 4 weeks prior to the first dose of HS-20093; History of other primary malignancies; Severe, uncontrolled or active cardiovascular diseases; Severe or poorly controlled hypertension; The presence of active infectious diseases has been known before the first dose such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc; Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis; Other moderate or severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity or may seriously affect respiratory function; History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins; Hypersensitivity to any ingredient of HS-20093; Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments; Treatment with any of the following:; Previous or current treatment with B7-H3 targeted therapy; Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093; Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093; Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093; Pleural or peritoneal effusion requiring clinical intervention. Pericardial effusion; Major surgery within 4 weeks of the first dose of HS-20093; Spinal cord compression or brain metastases; Treatment with drugs that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study; Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study; Diabetes ketoacidosis or hyperglycemia hypertonic occurring within 6 months before the first dose of the study drug, or the glycosylated hemoglobin value ≥ 7.5% in the screening period; Inadequate bone marrow reserve or organ dysfunction; Evidence of cardiovascular risk; Women who are breastfeeding or pregnant or planned to be pregnant during the study period; Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.

ClinicalTrials.gov NCT05830123