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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05942001
Collaborator
(none)
100
Enrollment
1
Arm
25.8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
HRS-5041 single armHRS-5041 single arm
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
Anticipated Study Start Date :
Jul 7, 2023
Anticipated Primary Completion Date :
Aug 31, 2025
Anticipated Study Completion Date :
Aug 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: HRS-5041

Drug: HRS-5041
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.

Outcome Measures

Primary Outcome Measures

  1. Dose-limiting toxicity (DLT) [Up to 28 days]

  2. Maximum tolerated dose (MTD) [Up to 28 days]

  3. Recommended Phase 2 Dose (RP2D) of HRS-5041 [Up to 28 days]

Secondary Outcome Measures

  1. Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria [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) [12 weeks]

  3. Pharmacokinetics - Maximum plasma concentration (Cmax) [12 weeks]

  4. Pharmacokinetics - Time to Cmax (Tmax) [12 weeks]

  5. Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50) [24 months]

  6. PSA Progression Free Survival (PFS) [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) [24 months]

  8. Radiographic progression free survival (rPFS) [24 months]

  9. Overall survival (OS) [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Able and willing to provide a written informed consent.

  2. Age 18-80 years old, gender unlimited.

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

  4. Predicted survival ≥12 weeks.

  5. Histological or cytological confirmed adenocarcinoma of the prostate.

  6. Patients progressed on taxane chemotherapy and at least one prior secondary hormonal therapy.

Exclusion Criteria:

  1. Prior treatment with an androgen receptor (AR) degrader.

  2. Plan to receive any other antitumor therapy during this trial.

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

  4. Patients with known brain metastases.

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05942001
Other Study ID Numbers:
  • HRS-5041-101
First Posted:
Jul 12, 2023
Last Update Posted:
Jul 12, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Jul 12, 2023