NCT05942001

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

August 3, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Completed
Last Updated

August 31, 2026

Status Verified

August 1, 2026

Enrollment Period

3.1 years

First QC Date

July 5, 2023

Last Update Submit

August 27, 2026

Conditions

Advanced Prostate Cancer

Outcome Measures

Primary Outcomes (3)

  • 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 (9)

  • 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)

    12 weeks

  • Pharmacokinetics - Maximum plasma concentration (Cmax)

    12 weeks

  • Pharmacokinetics - Time to Cmax (Tmax)

    12 weeks

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

    24 months

  • +4 more secondary outcomes

Study Arms (4)

HRS-5041

EXPERIMENTAL
Drug: HRS-5041

Docetaxel Injection + Prednisone Acetate Tablets group

ACTIVE COMPARATOR
Drug: Docetaxel injectionDrug: Prednisone Acetate Tablets

Abiraterone Acetate Tablets + Prednisone Acetate Tablets group

ACTIVE COMPARATOR
Drug: Abiraterone acetate tabletsDrug: Prednisone Acetate Tablets

Enzalutamide Soft Capsules group

ACTIVE COMPARATOR
Drug: Enzalutamide Soft Capsules

Interventions

HRS-5041DRUG

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
Docetaxel injectionDRUG

Docetaxel injection.

Docetaxel Injection + Prednisone Acetate Tablets group
Abiraterone acetate tabletsDRUG

Abiraterone Acetate tablets.

Abiraterone Acetate Tablets + Prednisone Acetate Tablets group
Prednisone Acetate TabletsDRUG

Prednisone Acetate tablets.

Abiraterone Acetate Tablets + Prednisone Acetate Tablets groupDocetaxel Injection + Prednisone Acetate Tablets group
Enzalutamide Soft CapsulesDRUG

Enzalutamide Soft capsules.

Enzalutamide Soft Capsules group

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

DocetaxelAbiraterone AcetatePrednisone

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediolsPregnadienesPregnanes

Central Study Contacts

Suyu Fan

CONTACT

+0518-81220121suyu.fan@hengrui.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: HRS-5041 single arm
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2023

First Posted

July 12, 2023

Study Start

August 3, 2023

Primary Completion

September 1, 2026

Study Completion

September 1, 2026

Last Updated

August 31, 2026

Record last verified: 2026-08

Locations

CN(1)