Who is sponsoring NCT07311694?

NCT07311694 is sponsored by Jiangsu HengRui Medicine Co., Ltd..

What drugs are being tested in NCT07311694?

Interventions in NCT07311694: HRS-4357 injection, Enzalutamide；Abiraterone.

Is NCT07311694 still recruiting?

NCT07311694 is currently recruiting now. Last updated 3 February 2026.

Last reviewed 2026-02-03 · How we verify

NCT07311694

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase III, Randomized, Open-Label, Multicenter Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

Recruiting now Phase 3 Last updated 3 February 2026

What this trial tests

Phase 3 trial testing HRS-4357 injection in PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer in 370 participants. Currently enrolling.

Timeline

2 February 2026

Primary endpoint
1 December 2027

1 December 2028

Quick facts

Lead sponsor	Jiangsu HengRui Medicine Co., Ltd.
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	370
Start date	2 February 2026
Primary completion	1 December 2027
Estimated completion	1 December 2028
Sites	1 location across China

Drugs / interventions tested

HRS-4357 injection — full drug profile →
Enzalutamide；Abiraterone

Conditions studied

PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer — all drugs for PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer →

Sponsor

Jiangsu HengRui Medicine Co., Ltd. — full company profile →

Who can join

18 and older, male only, with PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

radiographic progression-free survival (rPFS) assessed by the BIRC.
Time frame: From Baseline to primary completion date, about 24 months

Sponsor's own description

This study is a randomized, open-label, controlled, multicenter phase III clinical trial, which plans to randomly enroll 370 subjects with advanced metastatic castration-resistant prostate cancer (mCRPC). The efficacy of HRS-4357 versus novel androgen receptor pathway inhibitors (ARPI) in the treatment of PSMA-positive advanced metastatic castration-resistant prostate cancer (mCRPC) will be evaluated based on radiographic progression-free survival (rPFS) assessed by the BIRC.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of HRS-4357 injection

Trials testing the same drug.

NCT06006104 — Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer · Phase 1, PHASE2 · unknown

Other Jiangsu HengRui Medicine Co., Ltd. trials

Trials by the same sponsor.

NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07311694 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd.
Last refreshed: 3 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07311694.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing