A Phase 2 Study of HS-20089 for Injection in Patients With Recurrent or Metastatic Ovarian Cancer and Endometrial Cancer

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Lingying Wu
RECRUITING
Beijing
Peking University Cancer Hospital
RECRUITING
Beijing
Jilin Cancer Hospital
RECRUITING
Changchun
Hunan Cancer Hosipital
RECRUITING
Changsha
Xiangya Hospital of Central South University
RECRUITING
Changsha
Chongqing University cancer Hospital
SUSPENDED
Chongqing
The Second Hospital of Dalian Medical University
SUSPENDED
Dalian
Fujian Cancer Hospital
RECRUITING
Fuzhou
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
RECRUITING
Guangzhou
Hainan General Hospital
RECRUITING
Haikou
Zhejiang Cancer Hospital
RECRUITING
Hanzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Anhui Provincial Cancer Hospital
RECRUITING
Hefei
Cancer Hospital of Shandong First Medical University
RECRUITING
Jinan
Yunnan Cancer Hospital
RECRUITING
Kunming
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
Guangxi Cancer Hospital
RECRUITING
Nanning
Obstetrics & Gynecology Hospital of Fudan University
RECRUITING
Shanghai
Liaoning Cancer Hospital
RECRUITING
Shenyang
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
The fourth Hospital of Heibei Medical University
RECRUITING
Shijiazhuang
Shanxi Cancer Hospital
RECRUITING
Taiyuan
Tianjin Medical University cancer institute & Hospital
RECRUITING
Tianjin
Hubei Cancer University
RECRUITING
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
The first Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi’an
Affiliated Cancer Hospital of Xinjiang Medical University
RECRUITING
Xinjiang
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Lingying Wu, MD
wulingying@csco.org.cn
010-87788996
Backup
Dawei Wu
cancergcp@163.com
010-87788495
Time Frame
Start Date: 2023-12-18
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 460
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Hansoh BioMedical R&D Company

This content was sourced from clinicaltrials.gov

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