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Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

ConditionAdvanced Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-80
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

The purpose of this study is to assess the safety, tolerability and preliminary efficacy of HRS-5041 in men with progressive metastatic castration resistant prostate cancer. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of HRS-5041 in phase II study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide a written informed consent.

Age 18-80 years old, gender unlimited.

The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 ~ 1.

Predicted survival ≥12 weeks.

Disqualifiers

Prior treatment with an androgen receptor (AR) degrader.

Plan to receive any other antitumor therapy during this trial.

Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study.

Patients with known brain metastases.

Trial design

Design model

Single group

Treatments tested in this trial

  • HRS-5041

    Drug

    HRS-5041 was given oral administration, qd, at a 28-day cycle. Patients may continue to use HRS-5041 until disease progression or unacceptable toxicity occurs.

  • Docetaxel injection

    Drug

    Docetaxel injection.

  • Abiraterone acetate tablets

    Drug

    Abiraterone Acetate tablets.

  • Prednisone Acetate Tablets

    Drug

    Prednisone Acetate tablets.

  • Enzalutamide Soft Capsules

    Drug

    Enzalutamide Soft capsules.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: HRS-5041Experimental treatment 1 intervention
Group B: Docetaxel Injection + Prednisone Acetate Tablets groupActive comparator 2 interventions
Group C: Abiraterone Acetate Tablets + Prednisone Acetate Tablets groupActive comparator 2 interventions
Group D: Enzalutamide Soft Capsules groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Time frame
Up to 28 days
2

Maximum tolerated dose (MTD)

Time frame
Up to 28 days
3

Recommended Phase 2 Dose (RP2D) of HRS-5041

Time frame
Up to 28 days

Secondary outcomes

1

Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria

Time frame
From the time of consent at screening until 30 days after the subject discontinues study treatment, up to 2 years
2

Pharmacokinetics - Area under the plasma concentration time curve (AUC)

Time frame
12 weeks
3

Pharmacokinetics - Maximum plasma concentration (Cmax)

Time frame
12 weeks
4

Pharmacokinetics - Time to Cmax (Tmax)

Time frame
12 weeks

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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