NCT06006104

Brief Summary

The study is being conducted to evaluate the the safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy of HRS-4357 injection in adult patients with advanced prostate cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2023

Status
unknown

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

August 8, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 8, 2023

Last Update Submit

August 16, 2023

Conditions

Advanced Prostate Cancer

Outcome Measures

Primary Outcomes (4)

  • Prog Dose limiting toxicity (DLT)

    up to 9 months follow-up

  • recommended phase 2 dose (RP2D)

    up to 9 months follow-up

  • recommended dosing cycle.

    up to 9 months follow-up

  • PSA50 response rate

    up to 12 weeks follow-up

Secondary Outcomes (16)

  • Maximum plasma concentration (Cmax)

    up to 6 weeks follow-up

  • time to maximum plasma concentration (Tmax)

    up to 6 weeks follow-up

  • area under the plasma concentration-time curve (AUC)

    up to 6 weeks follow-up

  • clearance (Cl)

    up to 6 weeks follow-up

  • volume of distribution (Vz)

    up to 6 weeks follow-up

  • +11 more secondary outcomes

Study Arms (1)

HRS-4357 injection

EXPERIMENTAL
Drug: HRS-4357 injection

Interventions

HRS-4357 injectionDRUG

HRS-4357 injection

HRS-4357 injection

Eligibility Criteria

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

You may qualify if:

  • Voluntary participation in this clinical trial, understanding of the study procedures and being able to sign the informed consent form in writing;
  • Male, age ≥18 years;
  • ECOG score 0 - 1;
  • Histologically and/or cytologically confirmed adenocarcinoma of the prostate;

You may not qualify if:

  • Spinal cord compression with clinical symptoms, or clinical symptoms and/or imaging findings suggesting imminent spinal cord compression.
  • Severe urinary incontinence, hydronephrosis, severe micturition dysfunction, etc. Note: Subjects with bladder outflow obstruction or urinary incontinence that can be controlled by the best available standard of care (including pads, drainage, etc.) are eligible to participate in the study.
  • Active syphilis infection.
  • Known hypersensitivity to components of the study drug or its analogues.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Xueying Zheng

CONTACT

+0518-82342973xueying.zheng.xz17@hengrui.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 23, 2023

Study Start

September 30, 2023

Primary Completion

September 30, 2024

Study Completion

October 31, 2024

Last Updated

August 23, 2023

Record last verified: 2023-08