Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06763159

A Study 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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Affiliated Cancer Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 201321

Actively Recruiting

Loading map...

Research Team

X

Xiaohua Wu, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here