HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer

Sponsor
Hansoh BioMedical R&D Company
Study ID
NCT06014190
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HS-20089 — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 28, 2023
Start date
Dec 18, 2023
Status verified
Aug 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2027

Study Design

Enrollment
460 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 at 4.8 mg/kg of HS-20089 (Phase 2a)
    Patients in cohort 1 of phase 2a will be randomly assigned to receive HS-20089 at 4.8 mg/kg or 5.8 mg/kg.
  • Experimental: Cohort 1 at 5.8 mg/kg of HS-20089 (Phase 2a)
    Patients in cohort 1 of phase 2a will be randomly assigned to receive HS-20089 at 4.8 mg/kg or 5.8 mg/kg.
  • Experimental: Cohort 2 at 5.8 mg/kg of HS-20089 (Phase 2a)
    Patients in cohort 2 of phase 2a will receive HS-20089 at 5.8 mg/kg.
  • Experimental: Cohort 3 at 5.8 mg/kg of HS-20089 (Phase 2a)
    Patients in cohort 3 of phase 2a will receive HS-20089 at 5.8 mg/kg.
  • Experimental: Cohort 4 at 5.8 mg/kg of HS-20089 (Phase 2a)
    Patients in cohort 4 of phase 2a will receive HS-20089 at 5.8 mg/kg.
  • Experimental: Recommended dose of HS-20089 (Phase 2b)
    Patients of phase 2b will receive HS-20089 at recommended dose.

Primary Outcome Measure

Objective response rate (ORR) assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months. ]

Central Contacts

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