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HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer

NCT06014190 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2024-08-29

No results posted yet for this study

Summary

HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6.

This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20089 as monotherapy in patients with recurrent or metastatic ovarian cancer and endometrial cancer.

Conditions

Interventions

DRUG

HS-20089

All patients will receive intravenous HS-20089 once every three weeks (Q3W) until experiencing objective disease progression (except for study drug treatment beyond progression) or meeting other protocol-specified criteria of study treatment discontinuation.

Sponsors & Collaborators

  • Hansoh BioMedical R&D Company

    lead INDUSTRY

Principal Investigators

  • Lingying Wu, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2025-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06014190 on ClinicalTrials.gov