HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer
A Phase 2 Study of HS-20089 for Injection in Patients With Recurrent or Metastatic Ovarian Cancer and Endometrial Cancer
1 other identifier
interventional
460
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started Dec 2023
Typical duration for phase_2 ovarian-cancer
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2023
CompletedFirst Posted
Study publicly available on registry
August 28, 2023
CompletedStudy Start
First participant enrolled
December 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedAugust 29, 2024
August 1, 2024
2 years
August 16, 2023
August 27, 2024
Conditions
Keywords
Outcome Measures
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.
From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Secondary Outcomes (13)
ORR assessed by independent review committee (IRC) according to RECIST 1.1
From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Duration of response (DoR) assessed by investigators and IRC according to RECIST 1.1
From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Disease control rate (DCR) assessed by investigators and IRC according to RECIST 1.1
From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Progression-free survival (PFS) assessed by investigators and IRC according to RECIST 1.1
From the first dose or randomization to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Overall survival (OS)
From the first dose or randomization to death or withdrawal from study, whichever came first, assessed up to 24 months.
- +8 more secondary outcomes
Study Arms (6)
Cohort 1 at 4.8 mg/kg of HS-20089 (Phase 2a)
EXPERIMENTALPatients in cohort 1 of phase 2a will be randomly assigned to receive HS-20089 at 4.8 mg/kg or 5.8 mg/kg.
Cohort 1 at 5.8 mg/kg of HS-20089 (Phase 2a)
EXPERIMENTALPatients in cohort 1 of phase 2a will be randomly assigned to receive HS-20089 at 4.8 mg/kg or 5.8 mg/kg.
Cohort 2 at 5.8 mg/kg of HS-20089 (Phase 2a)
EXPERIMENTALPatients in cohort 2 of phase 2a will receive HS-20089 at 5.8 mg/kg.
Cohort 3 at 5.8 mg/kg of HS-20089 (Phase 2a)
EXPERIMENTALPatients in cohort 3 of phase 2a will receive HS-20089 at 5.8 mg/kg.
Cohort 4 at 5.8 mg/kg of HS-20089 (Phase 2a)
EXPERIMENTALPatients in cohort 4 of phase 2a will receive HS-20089 at 5.8 mg/kg.
Recommended dose of HS-20089 (Phase 2b)
EXPERIMENTALPatients of phase 2b will receive HS-20089 at recommended dose.
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.
Eligibility Criteria
You may qualify if:
- 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.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose.
- Have a life expectancy of at least 12 weeks.
- Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent until 6 months after the last dose; male subjects must agree to use barrier contraception (i.e. condoms) from signing the informed consent to 6 months after the last dose.
- Female subjects must have a negative pregnancy test within 7 days prior to the first dose (for subjects with tumor related abnormal elevation of human chorionic gonadotropin \[HCG\], an ultrasound of uterus and appendages should be performed within 7 days prior to the first dose to rule out pregnancy), or demonstrate no risk for pregnancy.
- Subject must be voluntarily enrolled in this clinical trial, be able to understand the study procedures and to sign written informed consent.
You may not qualify if:
- Have received or is currently receiving the following treatment:
- 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.
- Major surgery (such as craniotomy, thoracotomy or laparotomy, etc.) within 4 weeks prior to the first dose of study treatment.
- Use of strong inhibitors or inducers of CYP3A4, CYP2D6, P-gp, or BCRP, or sensitive substrates of CYP3A4, CYP2D6, P-gp, or BCRP with narrow therapeutic window within 7 days prior to the first dose of study drug; or in need of continuing treatment with these drugs during the study.
- Current use of drugs known to prolong the QT interval or potentially cause torsades de pointes; or need to continue these medications during the study.
- Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events (CTCAE version 5.0) due to prior anti-tumor therapy (except alopecia and residual neurotoxicity).
- Presence of pleural/abdominal effusion requiring clinical intervention.
- Known history of prior malignancy.
- Evidence of brain metastasis, unless meeting all of the following criteria:
- Asymptomatic; medically stable for at least four weeks prior to the first dose;
- No steroid treatment required for at least two weeks prior to the first dose;
- No stereotactic radiation therapy, whole brain radiotherapy, and/or neurosurgical resection within 4 weeks prior to the first dose;
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Anhui Provincial Cancer Hospital
Hefei, Anfei, China
Lingying Wu
Beijing, Beijing Municipality, 100020, China
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing University cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangzhou, Guangdong, China
Guangxi Cancer Hospital
Nanning, Guangxi, China
Hainan General Hospital
Haikou, Hainan, China
The fourth Hospital of Heibei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer University
Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hosipital
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
The first Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Tianjin Medical University cancer institute & Hospital
Tianjin, Tianjin Municipality, China
Affiliated Cancer Hospital of Xinjiang Medical University
Xinjiang, Xinjiang, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hanzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lingying Wu, MD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2023
First Posted
August 28, 2023
Study Start
December 18, 2023
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2027
Last Updated
August 29, 2024
Record last verified: 2024-08