ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors
Recruiting
Phase 1Interventional Study
Advanced Solid Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
610 (estimated)
Sponsor
Hansoh BioMedical R&D Company · Industry
Who this trial is looking for
This trial is looking for adults with advanced solid tumors that haven't responded to standard treatments or who haven't had prior treatment. Participants will receive the HS-20093 treatment along with other cancer therapies and will need to provide some medical information.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have advanced solid tumors confirmed by a doctor.
I have at least one measurable tumor outside the brain.
I agree to provide tumor tissue for testing.
I expect to live at least 12 weeks.
I use contraception if I am a woman of childbearing potential.
I can sign an informed consent form.
You may not be able to join if
I have received B7-H3 targeted therapy.
I had severe reactions to certain cancer treatments.
I had any anticancer treatment within 14 days before starting.
I had surgery within 4 weeks before starting.
I have other active cancers.
I have severe health problems or infections.
I am pregnant or breastfeeding.
I have a history of severe reactions to similar drugs.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
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. D…
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
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