Actively Recruiting
HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer
Led by Hansoh BioMedical R&D Company · Updated on 2024-08-29
460
Participants Needed
28
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years or older (≥18 years).
- Diagnosed with recurrent or metastatic ovarian cancer, endometrial cancer, or other solid tumors.
- Have at least one target lesion measurable by RECIST 1.1; patients with only brain and/or bone lesions are not eligible.
- Provide tumor tissue from a recent biopsy or archival tissue obtained within 2 years before the first dose.
- Eastern Cooperative Oncology Group Performance Status score of 0 to 1 without deterioration within 2 weeks before first dose.
- Life expectancy of at least 12 weeks.
- Female participants of childbearing potential agree to use contraception and not breastfeed from consent until 6 months after last dose; male participants agree to use barrier contraception during this period.
- Negative pregnancy test within 7 days prior to first dose or no risk of pregnancy.
- Able to voluntarily enroll and sign informed consent.
You will not qualify if you...
- Previous or current treatment with B7-H4-targeted therapies.
- Received cytotoxic chemotherapy, investigational drugs, anti-tumor traditional Chinese medicines, or other anti-tumor drugs within 14 days before first dose or require them during the study.
- Received macromolecular antitumor drugs (including immunotherapy) within 28 days before first dose.
- Received locoregional radiation therapy within 2 weeks or extensive radiation (>30% bone marrow irradiation or wide-field) within 4 weeks before first dose.
- Major surgery within 4 weeks before first dose.
- Use of strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers, or sensitive substrates within 7 days before first dose or require during study.
- Use of drugs known to prolong QT interval or cause torsades de pointes currently or during study.
- Presence of grade ≥2 toxicities from prior anti-tumor therapy (excluding alopecia and residual neurotoxicity).
- Presence of pleural or abdominal effusion requiring intervention.
- History of prior malignancy.
- Evidence of brain metastasis unless asymptomatic, stable for 4 weeks, no steroids for 2 weeks, no recent brain radiation or surgery, no history of hemorrhage, and presence of other measurable lesions.
- Inadequate bone marrow, liver, or kidney function.
- Cardiological abnormalities or severe uncontrolled cardiovascular disorders.
- Serious or poorly controlled diabetes or hypertension.
- Significant bleeding or thromboembolic events recently.
- Serious infections within 4 weeks prior to first dose.
- Recent or chronic systemic glucocorticoid use, immunodeficiency, or organ transplantation.
- Active infections like hepatitis B, C, tuberculosis, syphilis, or HIV.
- Severe liver conditions or moderate/severe lung diseases affecting treatment.
- History of severe neurological or psychiatric disorders.
- Pregnancy, breastfeeding, or intent to become pregnant during study.
- Recent live vaccinations within 4 weeks.
- Recent allergies or severe hypersensitivity to study drug components.
- Unlikely to comply with study procedures or safety concerns as judged by investigator.
- Any condition compromising safety or study assessments per investigator judgment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Anhui Provincial Cancer Hospital
Hefei, Anfei, China
Actively Recruiting
2
Lingying Wu
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
3
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
4
Chongqing University cancer Hospital
Chongqing, Chongqing Municipality, China
Suspended
5
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
6
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangzhou, Guangdong, China
Actively Recruiting
7
Guangxi Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
8
Hainan General Hospital
Haikou, Hainan, China
Actively Recruiting
9
The fourth Hospital of Heibei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
10
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
11
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
12
Hubei Cancer University
Wuhan, Hubei, China
Actively Recruiting
13
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
14
Hunan Cancer Hosipital
Changsha, Hunan, China
Actively Recruiting
15
Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
16
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Actively Recruiting
17
Jilin Cancer Hospital
Changchun, Jilin, China
Actively Recruiting
18
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Suspended
19
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Actively Recruiting
20
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
21
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Actively Recruiting
22
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
23
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Actively Recruiting
24
The first Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Actively Recruiting
25
Tianjin Medical University cancer institute & Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
26
Affiliated Cancer Hospital of Xinjiang Medical University
Xinjiang, Xinjiang, China
Actively Recruiting
27
Yunnan Cancer Hospital
Kunming, Yunnan, China
Actively Recruiting
28
Zhejiang Cancer Hospital
Hanzhou, Zhejiang, China
Actively Recruiting
Research Team
L
Lingying Wu, MD
CONTACT
D
Dawei Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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