Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer
ConditionAdvanced Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorHansoh BioMedical R&D Company
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HS-20093
- HRS-5041
Treatment groups
63 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov