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NCT Number: NCT05942001

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Wei Xue, Doctor

CONTACT

[email protected]

021-58752345

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Histological or cytological confirmed adenocarcinoma of the prostate.
  • Patients progressed on taxane chemotherapy and at least one prior secondary hormonal therapy.

Exclusion criteria

  • 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.
  • Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness.

Treatment and study plan

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.

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

  5. Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)

    Time frame: 24 months

  6. PSA Progression Free Survival (PFS)

    Time frame: 24 months

  7. Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

    Time frame: 24 months

  8. Radiographic progression free survival (rPFS)

    Time frame: 24 months

  9. Overall survival (OS)

    Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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