RecruitingPhase 1NCT06332170

ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors

ARTEMIS-101: A Phase 1, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administration of HS-20093 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors

Sponsor

Hansoh BioMedical R&D Company

Enrollment

610 participants

Start Date

Apr 26, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor

Summary

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. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced solid tumor patients.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

At least age of 18 years at screening;
Histologically or cytologically confirmed, locally advanced or metastatic solid tumors
Dose escalation part will enroll advanced solid tumor for which standard treatment has proven ineffective or unavailable or intolerable.
Dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease.
least one extra-cranial measurable lesion according to RECIST 1
Agree to provide fresh or archival tumor tissue
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1
Life expectancy >= 12 weeks
Agree to use medically accepted methods of contraception
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 Criteria14

Any of the following would exclude the subject from participation in the study:
treatment with any of the following: Previous or current treatment with B7-H3 targeted therapy Intolerable for any PD-L1 inhibitor, cetuximab, enzalutamide and cisplatin/ carboplatin 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 Major surgery within 4 weeks prior to the first scheduled dose of HS-20093
Subjects with previous or concurrent malignancies
Inadequate bone marrow reserve or organ dysfunction
Evidence of cardiovascular risk
Evidence of current severe or uncontrolled systemic diseases
Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093
Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first scheduled dose of HS-20093
Subjects with current infectious diseases
History of neuropathy or mental disorders
Pregnant or lactating female
History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20093 or any of the components of HS-20093
Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator
Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments