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Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06006104
Collaborator
(none)
49
Enrollment
1
Arm
13
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: HRS-4357 injection
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
49 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/II Clinical Study to Evaluate the Pharmacokinetics, Radiation Dosimetry, Safety and Preliminary Efficacy of HRS-4357 in Patients With PSMA Positive Advanced Prostate Cancer
Anticipated Study Start Date :
Sep 30, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Oct 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: HRS-4357 injection

Drug: HRS-4357 injection
HRS-4357 injection

Outcome Measures

Primary Outcome Measures

  1. Prog Dose limiting toxicity (DLT) [up to 9 months follow-up]

  2. recommended phase 2 dose (RP2D) [up to 9 months follow-up]

  3. recommended dosing cycle. [up to 9 months follow-up]

  4. PSA50 response rate [up to 12 weeks follow-up]

Secondary Outcome Measures

  1. Maximum plasma concentration (Cmax) [up to 6 weeks follow-up]

  2. time to maximum plasma concentration (Tmax) [up to 6 weeks follow-up]

  3. area under the plasma concentration-time curve (AUC) [up to 6 weeks follow-up]

  4. clearance (Cl) [up to 6 weeks follow-up]

  5. volume of distribution (Vz) [up to 6 weeks follow-up]

  6. terminal half-life (t1/2) [up to 6 weeks follow-up]

  7. cumulative urinary excretion of radioactive dose [up to 6 weeks follow-up]

  8. Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs; [up to 6 weeks follow-up]

  9. PSA90 response rate [up to 12 weeks follow-up]]

  10. time to PSA progression [up to 9 months follow-up]

  11. Overall Response Rate (ORR) [up to 20 months follow-up]

  12. Disease control Rate (DCR) [up to 20 months follow-up]

  13. Duration of Response (DoR) [up to 20 months follow-up]

  14. Radiographic Progression-free Survival (rPFS) [up to 9 months follow-up]

  15. Overall Survival (OS) [up to 20 months follow-up]

  16. Incidence and severity of AEs and SAEs [up to 20 months follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Voluntary participation in this clinical trial, understanding of the study procedures and being able to sign the informed consent form in writing;

  2. Male, age ≥18 years;

  3. ECOG score 0 - 1;

  4. Histologically and/or cytologically confirmed adenocarcinoma of the prostate;

Exclusion Criteria:

  1. Spinal cord compression with clinical symptoms, or clinical symptoms and/or imaging findings suggesting imminent spinal cord compression.

  2. 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.

  3. Active syphilis infection.

  4. Known hypersensitivity to components of the study drug or its analogues.

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:
NCT06006104
Other Study ID Numbers:
  • HRS-4357-101
First Posted:
Aug 23, 2023
Last Update Posted:
Aug 23, 2023
Last Verified:
Aug 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 Aug 23, 2023