HS-20093 plus HRS-5041 for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, phase Ib multicenter study administers escalating doses of HS-20093 in combination with HRS-5041 to define safety, tolerability, and pharmacokinetics. HS-20093 is a fully human IgG1 antibody-drug conjugate directed at B7-H3, while HRS-5041 is a PROTAC designed to degrade the androgen receptor. Eligible participants are men with metastatic castration-resistant prostate cancer who progressed after at least one novel hormonal therapy, have ECOG performance status 0–1, and an estimated life expectancy of at least 12 weeks. Key exclusions include prior B7-H3 targeted therapy or AR PROTAC exposure, recent cytotoxic or investigational agents within 21 days, brain metastases, and unresolved toxicities greater than Grade 2.

Why it matters

Who can join: the full rules

Inclusion 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).

Exclusion Criteria:

* 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 21 days prior to the first scheduled dose of HS-20093+HRS-5041. d. brain metastases.
* 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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.