Study of HRS-5041 in Patients With Metastatic Castration... | NCT05942001

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

NCT05942001

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Status

Recruiting

Last Update Posted

Feb 19, 2025Actual

Enrollment

100Estimated

Phase

Phase 1

Conditions

Advanced Prostate Cancer

Interventions

HRS-5041

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 3, 2023Actual

Primary Completion Date

Aug 31, 2025Estimated

Completion Date

Aug 31, 2025Estimated

First Submitted Date

Jul 5, 2023

First Submission Date that Met QC Criteria

Jul 5, 2023

First Posted Date

Jul 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2025

Last Update Posted Date

Feb 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HRS-5041	Experimental		Drug: HRS-5041

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	HRS-5041

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose-limiting toxicity (DLT)		Up to 28 days
Maximum tolerated dose (MTD)		Up to 28 days
Recommended Phase 2 Dose (RP2D) of HRS-5041		Up to 28 days

Secondary Outcomes

Measure	Description	Time Frame
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
Pharmacokinetics - Area under the plasma concentration time curve (AUC)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Suyu Fan	Contact	+0518-81220121		suyu.fan@hengrui.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Jiaotong University School of Medicine, Renji Hospital	Recruiting	Shanghai	Shanghai Municipality		China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided