HRS-5041 / Jiangsu Hengrui Pharma - LARVOL DELTA

Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=63 | Recruiting | Sponsor: Hansoh BioMedical R&D Company | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Trial completion date: Dec 2026 ➔ Jun 2027 | Trial primary completion date: Sep 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

HRS-5041, an androgen receptor (AR) degrader, in metastatic castration-resistant prostate cancer (mCRPC): a phase 1, multi-center, first-in-human study [WITHDRAWN] (ESMO 2025) - No abstract available

Clinical • First-in-human • Metastases • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR

A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Oral HRS-5041 in Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=63 | Not yet recruiting | Sponsor: Hansoh BioMedical R&D Company

New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: Atridia Pty Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Oral HRS-5041 in Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=25 | Not yet recruiting | Sponsor: Atridia Pty Ltd. | Initiation date: Mar 2025 ➔ Jun 2025

Trial initiation date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

HRS-5041-102: Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Atridia Pty Ltd. | Active, not recruiting ➔ Completed

Trial completion • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=25 | Not yet recruiting | Sponsor: Atridia Pty Ltd.

New P1 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

HRS-5041-102: Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Atridia Pty Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of HRS-2189 Combined HRS-5041 in Prostate Cancer (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Fudan University

Metastases • New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Hengrui Medicine’s 4 new cancer drugs approved for clinical trials, 3 of which are protein degraders [Google translation] (Sina Corp) - "On October 18, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Hengrui Medicine...has 4 new cancer drugs approved for multiple new clinical trial implied licenses. One of them is an anti-CTLA-4 monoclonal antibody new drug, and the other three are Class 1 new drugs for protein degradation therapy. These new drugs have been approved for clinical research on the treatment of malignant tumors with dual or triple drug combination therapy , which means that Hengrui Medicine has an important exploration direction in cancer treatment."

New trial • Oncology • Solid Tumor

HRS-5041-102: Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Atridia Pty Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Hengrui Medicine: HRS-1167 tablets, HRS-5041 tablets and SHR2554 tablets received drug clinical trial approval notice [Google translation] (Wallstreet.org) - "Hengrui Medicine announced that the company and its subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. recently received the 'Drug Clinical Trial Approval Notice' for HRS-1167 tablets, HRS-5041 tablets and SHR2554 tablets approved and issued by the National Medical Products Administration, and will conduct clinical trials in the near future. HRS-5041 tablets will be combined with HRS-1167 tablets, SHR2554 tablets, abiraterone acetate tablets (II) and docetaxel for clinical trials of advanced prostate cancer."

New trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer (clinicaltrials.gov) - P1/2 | N=100 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Metastases • New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Atridia Pty Ltd.

New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Metastases • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor