Actively Recruiting
Phase 1 Study Evaluating Safety, Dosage, and Effects of HS-20124 in Patients with Advanced Solid Tumors
Led by Hansoh BioMedical R&D Company · Updated on 2025-01-08
450
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating HS-20124, a new antibody-drug conjugate targeting CDH6, in patients with advanced solid tumors. This Phase 1a/1b open-label study aims to find the maximum tolerated dose, dose-limiting toxicities, pharmacokinetics, safety, and early anti-tumor effects of HS-20124. The study includes patients whose tumors express CDH6 and who have no effective or available standard treatments. Participants receive HS-20124 in 21-day dosing cycles during two study phases: dose escalation (Phase Ia) and dose expansion (Phase Ib). Treatment continues as long as there are no unacceptable side effects or clear disease progression. Dose escalation uses a rolling-6 design, and dose expansion includes specific tumor types for preliminary efficacy evaluation. Throughout the study, tumor response is measured by imaging compared to baseline tumor burden. Researchers assess the objective response rate, including complete responses, from the first dose until disease progression or withdrawal. Other evaluations include safety monitoring, pharmacokinetics, and tolerability. The study involves regular assessments to track tumor status and participant health.
CONDITIONS
Official Title
A Study of HS-20124 in Patients with Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at screening
- Confirmed locally advanced or metastatic solid tumors without effective or available standard treatment
- At least one measurable tumor lesion outside the brain according to RECIST 1
- ECOG Performance Status of 0 or 1
- Life expectancy of 12 weeks or more
- Using adequate contraception throughout the study
- Female participants must not be pregnant or have evidence of non-childbearing potential
- Signed and dated informed consent form
You will not qualify if you...
- Previous or current treatment targeting CDH6
- Cytotoxic chemotherapy or targeted anticancer drugs within 21 days or five half-lives before first HS-20124 dose
- Monoclonal antibody or investigational agent treatment within 28 days before first HS-20124 dose
- Limited field radiotherapy within 2 weeks, large-scale or bone marrow radiation within 4 weeks before first HS-20124 dose
- Major surgery within 4 weeks before first HS-20124 dose
- Previous or concurrent malignancies other than studied tumors
- Inadequate bone marrow or organ function
- Cardiovascular risk
- Severe or uncontrolled systemic diseases
- Mucosal or internal bleeding within 1 month before first HS-20124 dose
- Severe infection within 4 weeks before first HS-20124 dose
- Current infectious diseases
- History of neuropathy or mental disorders
- Pregnant or breastfeeding females
- History of severe hypersensitivity or infusion reactions to drugs related to HS-20124
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Affiliated Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201321
Actively Recruiting
Research Team
X
Xiaohua Wu, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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