Clinical trial · Interventional
Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer
A Phase Ib Study to Explore the Safety, Tolerability, and Pharmacokinetics of HS-20093 Combination With HRS-5041 in Patients With Advanced Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. This is a phase Ib, open-label, multi-center study to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-20093 combination with HRS-5041 in patients with advanced prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS-5041 | Drug | — | UNRESOLVED |
| HS-20093 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HS-20093+HRS-5041
- description
- Participants will receive HS-20093 at RP2D and HRS-5041 at Dose1 or Dose2.
- interventionNames
- Drug: HS-20093
- Drug: HRS-5041
Primary outcomes (1)
- measure
- To determine the maximum tolerated dose (MTD) or Maximum Administrated dose (MAD)
- timeFrame
- 21 days from administration of the first dose (C1D1) in the dose escalation phase， assessed up to 24 months
- description
- Number of participants with dose limiting toxicity
Secondary outcomes (10)
- measure
- To evaluate the incidence and severity of adverse events (AEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available