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Clinical Trials in China / NCT06332170
Recruiting Phase 1

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

NCT06332170 · tracked via the Priya Life Science China tracker
Sponsor
Hansoh BioMedical R&D Company
Phase
Phase 1
Started
2024-04-26
Last updated
2024-07-18

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

HS-20093AdebrelimabCisplatin/ CarboplatinCetuximabEnzalutamide

HS-20093: administered as an IV infusion

Adebrelimab: administered as an IV infusion

Cisplatin/ Carboplatin: administered as an IV infusion

Cetuximab: administered as an IV infusion

Enzalutamide: 160mg once daily (QD) orally

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * At least age of 18 years at screening; * Histologically or cytologically confirmed, locally advanced or metastatic solid tumors 1. Dose escalation part will enroll advanced solid tumor for which standard treatment has proven ineffective or unavailable or intolerable. 2. 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Chest Hospital Shanghai Shanghai Municipality Recruiting

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06332170 on ClinicalTrials.gov ↗ ← All trials in China