Actively Recruiting
A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying HS-20124, a new antibody-drug conjugate targeting CDH6, in patients with advanced solid tumors. This Phase 1a/1b open-label, multicenter trial aims to find the highest tolerated dose and assess safety, how the drug moves through the body, and early signs of anti-tumor activity. The trial includes patients with tumors that do not respond to standard treatments or for whom such treatments are not suitable. Participants receive HS-20124 through intravenous infusion in 21-day cycles. The study has two parts: dose escalation using a rolling-6 design to find the maximum tolerated dose, followed by dose expansion where selected doses are tested further for preliminary effectiveness in specific tumor types. Treatment continues until unacceptable side effects or clear disease progression occur. During the study, participants undergo imaging to measure tumor response compared to their baseline tumor size. Researchers monitor treatment-emergent side effects, drug levels in blood, immune response, and tumor response using established criteria. Safety is followed through 30 days after treatment ends. Participants are assessed regularly until disease progression or withdrawal. The study will continue until late 2027.
CONDITIONS
Brief 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
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors with no effective or available standard treatment
- At least one measurable extra-cranial lesion according to RECIST 1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of 12 weeks or more
- Adequate contraceptive measures used during the study for men and women
- 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 with CDH6 targeted therapy
- Cytotoxic chemotherapy or small molecule targeted anticancer drugs within 21 days or five half-lives before first HS-20124 dose
- Prior monoclonal antibody or investigational agent treatment within 28 days before first HS-20124 dose
- Radiotherapy for palliation within 2 weeks, large-scale radiotherapy within 4 weeks, or more than 30% bone marrow irradiation before first HS-20124 dose
- Major surgery within 4 weeks before first HS-20124 dose
- History of other malignancies
- 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 lactating females
- History of severe hypersensitivity or infusion reactions to HS-20124 or related drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive HS-20124 through 21-day dosing cycles. Treatment continues until the end of the study unless unacceptable toxicities or disease progression occur.
Regular visits for treatment administration and assessments every 21 days
Duration - 30 days post end of treatment
Participants are monitored for safety and adverse events after treatment ends.
Approximately 1 follow-up visit
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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