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New treatment option for Advanced Prostate Cancer
Official title Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer
ClinicalTrials.gov ID: NCT07115446
What this study is testing
What is HS-20093?
HS-20093 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. HRS-5041 is a Proteolysis Targeting Chimeras (PROTAC) targeting androgen receptors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Men greater than or equal to 18 years.
- Voluntarily to participate, Signed and dated Informed Consent Form.
- Patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after at least one type of novel hormonal therapy (standard...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1.
- Estimated life expectancy ≥ 12 weeks.
You likely can't join if
- Treatment with any of the following: a. Previous or current treatment with B7-H3 targeted therapy. b. Previous treatment with AR PROTAC. c. Any...
- Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
- History of other primary malignancies.
- Inadequate bone marrow reserve or organ dysfunction.
- Severe, uncontrolled or active cardiovascular diseases.
- Severe or uncontrolled diabetes.
See the full eligibility criteria
- Men greater than or equal to 18 years.
- Voluntarily to participate, Signed and dated Informed Consent Form.
- Patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after at least one type of novel hormonal therapy (standard treatment).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1.
- Estimated life expectancy ≥ 12 weeks.
- Men should use adequate contraceptive measures throughout the study, up to 3 months after the last dose of HRS-5041 or 4.5 months after the last dose of HS-20093 (whichever is later).
- Treatment with any of the following: a. Previous or current treatment with B7-H3 targeted therapy. b. Previous treatment with AR PROTAC. c. Any cytotoxic chemotherapy, investigational agents and anticancer drugs within...
- Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
- History of other primary malignancies.
- Inadequate bone marrow reserve or organ dysfunction.
- Severe, uncontrolled or active cardiovascular diseases.
- Severe or uncontrolled diabetes.
- The presence of active infectious diseases.
- Any known or suspected interstitial lung disease.
- History of serious neuropathy or mental disorders.
- History of severe hypersensitivity reaction, severe infusion reaction.
- Hypersensitivity to any ingredient of HS-20093.
- Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.
- Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.