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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • HS-20093

    Drug

    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.

  • HRS-5041

    Drug

    HRS-5041 was given oral administration, QD, at a 21-day cycle.

Treatment groups

63 Participants
are divided into 1 treatment group
Group A: HS-20093+HRS-5041Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

To determine the maximum tolerated dose (MTD) or Maximum Administrated dose (MAD)

Number of participants with dose limiting toxicity

Time frame
21 days from administration of the first dose (C1D1) in the dose escalation phase， assessed up to 24 months

Secondary outcomes

1

To evaluate the 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 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(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)
2

To evaluate the maximum plasma concentration (Cmax)

Cmax will be obtained following administration of the first dose of HS-20093 during the first cycle

Time frame
up to approximately 24 months
3

To evaluate the Time to reach maximum plasma concentration (Tmax)

Tmax will be obtained following administration of the first dose of HS-20093 during the first cycle

Time frame
up to approximately 24 months
4

To evaluate the Area under plasma concentration versus time curve from zero to last sampling time (AUC)

Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration was no less than the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule

Time frame
up to approximately 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hansoh BioMedical R&D Company

Lead sponsor

Source ClinicalTrials.gov
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