Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT06763159
Recruiting Phase 1

A Study of HS-20124 in Patients with Advanced Solid Tumors

NCT06763159 · tracked via the Priya Life Science China tracker
Sponsor
Hansoh BioMedical R&D Company
Phase
Phase 1
Started
2024-10-30
Last updated
2025-01-08

Condition(s) studied

Solid Cancer

Investigational drug(s) / intervention(s)

HS-20124 (Phase Ia：Dose escalation )HS-20124 (Phase Ib: Dose expansion)

HS-20124 (Phase Ia：Dose escalation ): Participants will receive HS-20124 in 21 day dosing cycles. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.

HS-20124 (Phase Ib: Dose expansion): Participants will receive HS-20124 in 21 day dosing cycles. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.

Study summary

HS-20124 is a novel DAR-8 antibody-drug conjugate （ADC） targeting CDH6. In preclinical studies, it inhibited tumor cell growth expressing CDH6 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-20124 in Patients With Advanced Solid Tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. At least age of 18 years at screening; 2. Histologically or cytologically confirmed, locally advanced or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable 3. At least one extra-cranial measurable lesion according to RECIST 1 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1 5. Life expectancy \>= 12 weeks 6. Men or women should be using adequate contraceptive measures throughout the study; 7. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential 8. Signed and dated Informed Consent Form Exclusion Criteria: 1.Treatment with any of the following: 1. Previous or current treatment with CDH6 targeted therapy 2. Any cytotoxic chemotherapy and small molecule targeted anticancer drugs within 21 days or five half-livesprior to the first scheduled dose of HS-20124 3. Prior treatment with a monoclonal antibody or investigational agents within 28 days prior to the first scheduled dose of HS-20124 4. 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-20124 5. Major surgery within 4 weeks prior to the first scheduled dose of HS-20124 2. Subjects with previous or concurrent malignancies 3. Inadequate bone marrow reserve or organ dysfunction 4. Evidence of cardiovascular risk 5. Evidence of current severe or uncontrolled systemic diseases 6. Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20124 7. Severe infection within 4 weeks prior to the first scheduled dose of HS-20124 8. Subjects with current infectious diseases 9. History of neuropathy or mental disorders 10. Pregnant or lactating female 11. History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20124 or any of the components of HS-20124

Primary outcome measure(s)

  • Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of complete response (CR) an — 3 weeks after initiation of treatment
    To determine the MTD/MAD for further evaluation of IV administration of HS-20124 in subjects with advanced solid tumors
  • Ⅰb (Dose-Expansion Stage): Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 — From the first dose up to PD or withdrawal from study, whichever came first.
    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of complete response (CR) and partial response (PR) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\]

Trial sites (1)

FacilityCityRegionStatus
Affiliated Cancer Hospital of Fudan University Shanghai Shanghai Municipality Recruiting

More Hansoh BioMedical R&D Company trials in China

A Phase II Study of HS-20093 Injection Combined With Adebrelimab Versus HS-20093 Injection in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations Recruiting
Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer Recruiting
Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors Recruiting
A Phase I Clinical Study of HS-20117 in Participants With Advanced Solid Tumors Starting soon
A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis Starting soon

Other trials for the same condition

TC-G203 for Patients With GPC3-Positive Advanced Solid Tumors Recruiting
Evaluation of the Effect of Cordycepin on CD8+ Lymphocytopenia in Patients With Solid Tumors Recruiting
A Study of SI-B036 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors Starting soon
Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors Active, not recruiting
PRaG-1 Plus PRaG Therapy in in Elderly Patients With Advanced Solid Tumors: A Prospective Clinical Trial (PRaG 10.0) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06763159 on ClinicalTrials.gov ↗ ← All trials in China