Health TrialsbyHealthPanel

A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer

ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-80
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

This is a phase II, multicentre clinical study investigating HS-20093 or SHR2554 in combination with a Novel Hormonal Agent (NHA) for advanced prostate cancer. The trial comprises two cohorts.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in this clinical study, understand the research procedures, and are able to provide written informed consent.

Aged 18 to 80 years (inclusive), male.

ECOG performance status of 0 or 1.

Expected survival time ≥12 weeks.

Disqualifiers

Known hypersensitivity or intolerance to the investigational drug(s) or their excipients.

Adverse events from prior anti-tumor therapy have not recovered to Grade ≤1 as per CTCAE v5.0.

Administration of estrogen, progesterone, or 5-alpha reductase inhibitors within 28 days prior to enrollment.

Administration of herbal medicines known to have anti-prostate cancer or PSA-lowering effects within 14 days prior to enrollment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HS-20093 for Injection

    Drug

    HS-20093 for injection.

  • SHR3680 Tablet

    Drug

    SHR3680 tablet.

  • Abiraterone Tablet

    Drug

    Abiraterone tablet.

  • SHR2554 Tablet

    Drug

    SHR2554 tablet.

  • Enzalutamide Tablet

    Drug

    Enzalutamide tablet.

  • Darotamine Capsule

    Drug

    Darotamine capsule.

Treatment groups

218 Participants
are divided into 2 treatment groups
Group A: Cohort 1 GroupExperimental treatment 3 interventions
Group B: Cohort 2 GroupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Cohort 1: 6-month undetectable Prostate Specific Antigen (PSA) rate.

Time frame
6 months.
2

Cohort 2: Prostate Specific Antigen (PSA) response rate.

Time frame
About 2 years.
3

Cohort 2: Adverse events (AEs).

Time frame
About 2 years.
4

Cohort 2: Dose-limiting toxicity (DLT).

Time frame
About 28 days.

Secondary outcomes

1

Radiographic Progression-Free Survival (rPFS).

Time frame
About 2 years.
2

Time to Prostate Specific Antigen (PSA) progression.

Time frame
About 2 years.
3

Time to Next Symptomatic Skeletal Event (SSE).

Time frame
About 2 years.
4

Time to Next Antineoplastic Therapy (TTNT).

Time frame
About 2 years.

Other outcomes

Sponsors and contacts

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

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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