ARTEMIS-003: HS-20093 in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) and Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
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. The objectives of this study are to investigate the anti-tumor activity, safety and pharmacokinetics of HS-20093 in Chinese patients with metastasis Castration Resistant Prostate Cancer.
This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) of HS-20093 as a monotherapy in subjects with metastasis castration resistant prostate cancers (mCRPC) and other solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women greater than or equal to 18 years.
Locally advanced or metastatic solid tumors confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable.
At least one measurable lesion in accordance with RECIST 1.1.
Agree to provide fresh archival tumor tissue.
Disqualifiers
Patients with BRCA and ATM mutation.
Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity
History of other primary malignancies.
Inadequate bone marrow reserve or organ dysfunction.
Trial design
Design model
Single group
Treatments tested in this trial
HS-20093
DrugIntravenous (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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: HS-20093Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR) determined by investigators
Cohort 1(mCRPC): Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3 (PCWG3) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\]. Cohort 2(Other advanced solid tumors)：Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\].
Time frame
From the first dose up to disease progression or withdrawal from study, which ever came first, assessed up to 24 monthsSecondary outcomes
1
Incidence and severity of adverse events (AEs).
AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0\]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc.
Time frame
From the first dose through 90 days post end of treatment.2
Observed maximum plasma concentration (Cmax) of HS-20093.
Cmax will be obtained following administration of the first dose of HS-20093 during the first cycle.
Time frame
From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days)3
Time to reach maximum plasma concentration (Tmax) of HS-20093 following the first dose.
Tmax will be obtained following administration of the first dose of HS-20093 during the first cycle.
Time frame
From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).4
Terminal half-life (T1/2) of HS-20093 following the first dose.
Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.
Time frame
From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).Sponsors and contacts
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Source ClinicalTrials.gov