What is HS-20089 studying for ovarian and endometrial cancer?

HS-20089 is being studied to evaluate its effects in patients with recurrent or metastatic ovarian and endometrial cancer. Researchers want to understand the drug's safety, how it acts in the body, and its ability to affect tumor growth. The trial is sponsored by Hansoh BioMedical R&D Company to explore new treatment options for these cancers.

Who may be eligible for this ovarian and endometrial cancer clinical trial?

Adults aged 18 years or older diagnosed with recurrent or metastatic ovarian cancer, endometrial cancer, or other solid tumors may be eligible. Participants should have measurable tumor lesions and a good performance status. They must not be pregnant and need to agree to use contraception if applicable. Please review eligibility criteria for more details.

Is there any cost to participate in this ovarian and endometrial cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal expenses such as travel may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06014190

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

Led by Hansoh BioMedical R&D Company · Updated on 2024-08-29

460

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating HS-20089, an investigational antibody-drug conjugate, in patients with recurrent or metastatic ovarian cancer and endometrial cancer. This phase 2, open-label, multi-center study aims to assess the drugs effectiveness, safety, how the body processes it, and its immune response. The study includes patients with different types of ovarian and endometrial cancers, some of whom have already undergone standard platinum-based chemotherapy treatments. The study has two parts phase 2a and phase 2b. In phase 2a, patients are divided into cohorts based on their cancer type and prior treatments. Some patients are randomly assigned to receive HS-20089 at doses of 4.8 mgkg or 5.8 mgkg every three weeks, while others receive 5.8 mgkg. In phase 2b, patients receive HS-20089 at a recommended dose determined by earlier research. Treatment continues until disease progression or other criteria for stopping treatment are met. Participants will have tumor assessments using RECIST 1.1 criteria at regular intervals to measure response to the treatment. Researchers will monitor safety by tracking side effects and immune reactions, and measure how the drug is processed in the body. The main outcome is the objective response rate over up to 24 months. Additional measurements include progression-free survival, overall survival, and disease control rate. Participants are followed from the first dose until disease progression or withdrawal from the study.

CONDITIONS

Brief Title

HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer

Who Can Participate

Age: 18Years +

All Genders

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 (excluding only brain and/or bone lesions).
Provide tumor tissue from a recent biopsy or archival tissue within 2 years.
Eastern Cooperative Oncology Group Performance Status score of 0 to 1 with no recent decline.
Life expectancy of at least 12 weeks.
Female participants of childbearing potential agree to use contraception and avoid breastfeeding from consent until 6 months after last dose; male participants agree to use barrier contraception.
Negative pregnancy test within 7 days before first dose or no risk of pregnancy.
Able to understand and voluntarily sign informed consent.

You will not qualify if you...

Have received or are currently receiving 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 need to continue these drugs during the study.
Received macromolecular antitumor drugs (including immunotherapy) within 28 days before first dose.
Had locoregional radiation within 2 weeks, or extensive bone marrow/wide-field radiation within 4 weeks before first dose.
Major surgery within 4 weeks before first dose.
Use of strong enzyme inhibitors/inducers or drugs prolonging QT interval within 7 days before first dose or need to continue them during study.
Grade 2 or higher toxicities from prior anti-tumor therapy (except alopecia and residual neurotoxicity).
Presence of pleural or abdominal effusion needing clinical intervention.
History of prior malignancy.
Brain metastasis unless asymptomatic, stable, off steroids, no recent brain radiation or surgery, no hemorrhage history, and have other measurable lesions.
Inadequate bone marrow, liver, or kidney function.
Cardiological abnormalities or severe uncontrolled cardiovascular disorders.
Serious or uncontrolled diabetes or hypertension.
Significant bleeding or thromboembolic events recently.
Serious infections within 4 weeks before first dose.
Recent or ongoing systemic glucocorticoid therapy or immunodeficiency.
Active infectious diseases such as hepatitis B, C, tuberculosis, syphilis, or HIV.
Severe liver conditions.
Moderate or severe lung diseases affecting pulmonary toxicity detection or respiratory function.
Severe neurological or psychiatric disorders.
Pregnant or breastfeeding women or those intending pregnancy during the study.
Recent live attenuated vaccination within 4 weeks before first dose.
Severe allergies, infusion reactions, or hypersensitivity to HS-20089.
Unlikely to comply with study procedures or safety concerns as judged by investigator.

Research Team

Lingying Wu, MD

Dawei Wu

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

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria