At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Recurrent or metastatic ovarian cancer, endometrial cancer, or other solid tumors
- ✓At least one measurable target lesion per RECIST 1.1 (excluding brain/bone only)
- ✓Newly obtained tumor tissue (FFPE biopsy or archival blocks from within 2 years)
- ✕Prior B7-H4-targeted therapies
- ✕Cytotoxic chemotherapy or investigational drugs within 14 days
- ✕Macromolecular antitumor drugs or immunotherapy within 28 days
- ✕Radiation therapy within 2 weeks (locoregional) or 4 weeks (extensive)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT06014190Phase 2RecruitingUpdate OverdueUpdated 22mo ago · Completion was 6mo agoA Phase 2 Study of HS-20089 for Injection in Patients With Recurrent or Metastatic Ovarian Cancer and Endometrial Cancer
In Brief
A Phase 2 clinical trial evaluating HS-20089 for Ovarian Cancer and 3 related conditions. Currently recruiting, targeting 460 participants across 28 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
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.