Actively Recruiting
ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors
Led by Hansoh BioMedical R&D Company · Updated on 2024-07-18
610
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at screening
- Histologically or cytologically confirmed, locally advanced or metastatic solid tumors
- Dose escalation part: advanced solid tumor with ineffective or unavailable or intolerable standard treatment
- Dose expansion part: no prior treatment for advanced/metastatic disease
- At 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 to 1
- Life expectancy of at least 12 weeks
- Agree to use medically accepted contraception methods
- Men or women must use adequate contraception throughout the study
- Female subjects must not be pregnant at screening or have evidence of non-childbearing potential
- Signed and dated Informed Consent Form
You will not qualify if you...
- Previous or current treatment with B7-H3 targeted therapy
- Intolerable for any PD-L1 inhibitor, cetuximab, enzalutamide, or cisplatin/carboplatin
- Cytotoxic chemotherapy, investigational agents, or anticancer drugs within 14 days before first HS-20093 dose
- Monoclonal antibody treatment within 28 days before first HS-20093 dose
- Radiotherapy for palliation within 2 weeks, or more than 30% bone marrow irradiation, or large-scale radiotherapy within 4 weeks before first HS-20093 dose
- Major surgery within 4 weeks before first HS-20093 dose
- Previous or concurrent malignancies
- Inadequate bone marrow reserve or organ dysfunction
- Evidence of cardiovascular risk
- Current severe or uncontrolled systemic diseases
- Mucosal or internal bleeding within 1 month before first HS-20093 dose
- Active infection needing antibiotics within 2 weeks or severe infection within 4 weeks before first HS-20093 dose
- Current infectious diseases
- History of neuropathy or mental disorders
- Pregnant or lactating females
- History of severe hypersensitivity or infusion reactions to HS-20093 or related drugs
- Unlikely to comply with study procedures or restrictions
- Any condition compromising safety or study assessments in investigator's opinion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
H
Hua Zhong, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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