Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HS-20093, HRS-5041.
- Who it may be relevant to
- Registry conditions: Advanced Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase Ib Study to Explore the Safety, Tolerability, and Pharmacokinetics of HS-20093 Combination With HRS-5041 in Patients With Advanced Prostate Cancer
Overview
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.
Interventions
- Drug HS-20093
Intravenous (IV) administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression. - Drug HRS-5041
HRS-5041 was given oral administration, QD, at a 21-day cycle.
Primary outcome measures
- To determine the maximum tolerated dose (MTD) or Maximum Administrated dose (MAD) [Time frame: 21 days from administration of the first dose (C1D1) in the dose escalation phase， assessed up to 24 months]
Secondary outcome measures (10)
- To evaluate the incidence and severity of adverse events (AEs) [Time frame: From the first dose(C1D1) up to 30 days after the last dose of HRS-5041 or 90 days after the last dose of HS-20093 (whichever is later)]
- To evaluate the maximum plasma concentration (Cmax) [Time frame: up to approximately 24 months]
- To evaluate the Time to reach maximum plasma concentration (Tmax) [Time frame: up to approximately 24 months]
- To evaluate the Area under plasma concentration versus time curve from zero to last sampling time (AUC) [Time frame: up to approximately 24 months]
- To evaluate the immunogenicity of HS-20093 [Time frame: up to approximately 24 months]
- To evaluate the ORR determined by investigators [Time frame: up to approximately 24 months]
- To evaluate the Disease control rate (DCR) determined by investigators according to RECIST 1.1 and PCWG3 [Time frame: up to approximately 24 months]
- To evaluate the Duration of response (DoR) determined by investigators according to RECIST 1.1 and PCWG3 [Time frame: up to approximately 24 months]
- To evaluate the Prostate-specific Cancer Antigen (PSA) response rate（PSA30,PSA50,PSA90） [Time frame: up to approximately 24 months]
- To evaluate the Time to PSA progression [Time frame: up to approximately 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT07115446 · HS-20093-107