NCT06332170 ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors
| NCT ID | NCT06332170 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hansoh BioMedical R&D Company |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 610 participants |
| Start Date | 2024-04-26 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 610 participants in total. It began in 2024-04-26 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06332170 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06332170 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06332170 currently recruiting?
Yes, NCT06332170 is actively recruiting participants. Contact the research team at shsxkyy@hotmail.com for enrollment information.
Where is the NCT06332170 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06332170 clinical trial?
NCT06332170 is sponsored by Hansoh BioMedical R&D Company. The trial plans to enroll 610 participants.