HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or females aged 18 years or older (≥18 years).
Patients diagnosed with recurrent or metastatic ovarian cancer, endometrial cancer or other solid tumors.
Subjects have at least one target lesion as assessed per the RECIST 1.1. Patients with only brain and/or bone lesions as target lesions are ineligible.
Tumor tissue from a newly obtained biopsy (FFPE tumor tissue blocks or slides are acceptable) is required. If the newly obtained biopsy is not feasible, newly obtained FFPE slides cut from archival tumor tissue blocks within 2 years prior to the first dose of study drug are acceptable.
Disqualifiers
B7-H4-targeted therapies.
Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, biotherapy, etc.) within 14 days prior to the first dose of study drug; or need to continue these drugs during the study.
Have received macromolecular antitumor drugs (including immunotherapy, such as monoclonal antibodies and bispecific antibodies) within 28 days prior to the first dose of study drug.
Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
HS-20089
DrugAll 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.
Treatment groups
460 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Cohort 1 at 4.8 mg/kg of HS-20089 (Phase 2a)Experimental treatment 1 intervention
Group B: Cohort 1 at 5.8 mg/kg of HS-20089 (Phase 2a)Experimental treatment 1 intervention
Group C: Cohort 2 at 5.8 mg/kg of HS-20089 (Phase 2a)Experimental treatment 1 intervention
Group D: Cohort 3 at 5.8 mg/kg of HS-20089 (Phase 2a)Experimental treatment 1 intervention
Group E: Cohort 4 at 5.8 mg/kg of HS-20089 (Phase 2a)Experimental treatment 1 intervention
Group F: Recommended dose of HS-20089 (Phase 2b)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR) assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
ORR is defined as the percentage of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or partial response (PR), assessed by investigators based on 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.Secondary outcomes
1
ORR assessed by independent review committee (IRC) according to RECIST 1.1
ORR is defined as the percentage of participants who achieved a BOR of confirmed CR or PR, assessed by IRC based on RECIST 1.1.
Time frame
From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.2
Duration of response (DoR) assessed by investigators and IRC according to RECIST 1.1
DoR is defined as the period from the first occurrence of CR or PR to progressive disease (PD) or death of any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) will be used.
Time frame
From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.3
Disease control rate (DCR) assessed by investigators and IRC according to RECIST 1.1
DCR is defined as the percentage of participants with BOR of confirmed CR, PR and stable disease (SD).
Time frame
From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.4
Progression-free survival (PFS) assessed by investigators and IRC according to RECIST 1.1
PFS is defined as the time from first dose or randomization (if any) to PD or death of any cause.
Time frame
From the first dose or randomization to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.Sponsors and contacts
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Source ClinicalTrials.gov