RecruitingPhase 2NCT06014190

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

Sponsor

Hansoh BioMedical R&D Company

Enrollment

460 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Endometrial Cancer Primary Peritoneal Cancer Fallopian Tube Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an experimental drug called HS-20089 for people with recurrent or metastatic ovarian cancer, endometrial (uterine) cancer, or other solid tumors. The study is evaluating how safe it is and how well it works. **You may be eligible if...** - You are 18 or older - You have confirmed recurrent or metastatic ovarian or endometrial cancer, or another solid tumor - You have at least one measurable tumor that is not located only in the brain or bones - You are in good health (ECOG 0–1) with no rapid decline in the past 2 weeks - You have a life expectancy of at least 12 weeks - A recent tumor biopsy or archival tumor sample is available **You may NOT be eligible if...** - You have only brain or bone lesions as your measurable disease - Your overall health has declined rapidly in the 2 weeks before enrollment - You are pregnant or breastfeeding - You are unwilling to use contraception during and after treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHS-20089

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.

Locations(28)

Anhui Provincial Cancer Hospital

Hefei, Anfei, China

Lingying Wu

Beijing, Beijing Municipality, 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

View Full Details on ClinicalTrials.gov

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NCT06014190

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