Clinical trials: sponsored by Jiangsu HengRui Medicine Co., Ltd.
Advanced Solid Tumors
A Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HRS-4508 Monotherapy in Patients With Advanced or Metastatic Solid Tumors
The study is being conducted to evaluate the efficacy and safety of HRS-4508 in subjects with advanced or metastatic solid tumors and explore the reasonable dosage of HRS-4508.
- Trial name
- NCT06598735
- Testing
- HRS-4508
- Where
- China
- Volunteers
- 290 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Abirritation in the ICU
A Trial of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in the Intensive Care Unit (ICU)
The purpose of this study is to evaluate the efficacy and safety of Tegileridine Fumarate lnjection for prolonged abirritation(48h to 72h) during mechanical ventilation in the ICU.
- Trial name
- NCT07372924
- Testing
- Tegileridine Fumarate lnjection, Remifentanil Hydrochloride for Injection
- Where
- 2 sites in China
- Volunteers
- 121 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Locally Advanced, Recurrent or Metastatic ESCC Patients Who Have Failed Prior PD-1/PD-L1 Inhibitors Combined With Platinum-based Chemotherapy
FH-006 Versus Investigator's Choice of Chemotherapy in Patients With Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma Who Have Failed Prior PD-1/PD-L1 Inhibitor Combined With Platinum-Based Chemotherapy.
The study compares the overall survival (OS) of FH-006 and the second-line chemotherapy selected by the investigators for treating esophageal squamous cell carcinoma patients.
- Trial name
- NCT07790380
- Testing
- FH-006, Paclitaxel, Docetaxel, Irinotecan
- Where
- China
- Volunteers
- 480 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Type 2 Diabetes
The Experiment of Noiiglutide Injection in Type 2 Diabetes Patients
This study aims to confirm that SHR20004 is more effective than placebo in controlling blood glucose in patients with type 2 diabetes. Evaluate the efficacy, safety, and pharmacokinetics of SHR20004 after 24 weeks of treatment.
- Trial name
- NCT06649773
- Testing
- Noiiglutide Injection
- Where
- China
- Volunteers
- 137 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
A Study to Estimate Effect of Formulation and Food on Relative Bioavailability of HRS-6209 in Healthy Participants
This is a phase 1, randomised, open-label, three-way, three-period, crossover relative bioavailability study to assess the pharmacokinetics of HRS-6209 capsules (old and new formulation) in healthy participants.
- Trial name
- NCT07610148
- Testing
- HRS-6209 Capsule (old formulation), HRS-6209 Capsule (new formulation)
- Where
- China
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab.
- Trial name
- NCT03980054
- Testing
- Pyrotinib
- Where
- China
- Volunteers
- 2,135 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Moderate to Severe Ulcerative Colitis
A Trial of HRS-7085 Tablets in Patients With Moderate to Severe Active Ulcerative Colitis
The study is being conducted to evaluate the safety, tolerability and pharmakokinetics of HRS-7085 in adults.
- Trial name
- NCT07760831
- Testing
- HRS-7085 tablets
- Where
- Moldova
- Volunteers
- 8 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.
- Trial name
- NCT05814354
- Testing
- SHR-A1811, Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel
- Where
- China
- Volunteers
- 551 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors
SHR-4602 for Injection in Subjects With HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors
This is an open-label, randomized, multi-center phase II study to evaluate the safety, tolerability, PK, and efficacy of SHR-4602 monotherapy in subjects with HER2-expressing or -mutated unresectable or metastatic solid tumors.
- Trial name
- NCT06516926
- Testing
- SHR-4602
- Where
- China
- Volunteers
- 11 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hypercholesterolemia and Hyperlipidemia
Study of SHR-1209 Administered by Single-site or Multiple-site Subcutaneous Injections in Healthy Volunteers
In order to improve the medication convenience and compliance of patients and facilitates in the long-term control of disease condition, it is planned to reduced the number of injections to one per administration.
- Trial name
- NCT06837077
- Testing
- SHR-1209 single-site subcutaneous injection, SHR-1209 multiple-site subcutaneous injections
- Where
- China
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Early-stage or Locally Advanced HER2-positive Breast Cancer
A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer
This study is a multicenter, randomized, open-label, parallel Phase III clinical trial. 650 early-stage or locally advanced breast cancer participants will be enrolled and randomly assigned to SHR-A1811 monotherapy group (trial…
- Trial name
- NCT07196774
- Testing
- SHR-A1811 for Injection, Docetaxel injection, Trastuzumab Injection
- Where
- 2 sites in China
- Volunteers
- 740 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
HER2 Expression / Amplification in Patients With Biliary Tract Cancer
Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
This study was to evaluate the efficacy and safety of SHR-A1811 in patients with locally advanced unresectable or recurrent metastatic BTC with HER2 expression / amplification who failed first-line or second-line systemic…
- Trial name
- NCT06413745
- Testing
- SHR-A1811
- Where
- China
- Volunteers
- 59 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
KRAS G12D-Mutant Advanced or Metastatic Pancreatic Cancer in the First-line Setting
HRS 4642 Injection Combined With AG Versus Placebo Combined With AG Therapy in First-Line Advanced or Metastatic Pancreatic Cancer
This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation. Patients were randomized 1:1 to receive either the experimental regimen HRS-4642 plus AG or the control regimen AG alone.
- Trial name
- NCT07232875
- Testing
- HRS-4642 + AG
- Where
- China
- Volunteers
- 588 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
This study aims to Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants with Residual Invasive Disease Following Neoadjuvant Therapy，This study will examine…
- Trial name
- NCT06126640
- Testing
- SHR-A1811, Trastuzumab Emtansine
- Where
- 2 sites in China
- Volunteers
- 1,615 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Solid Tumor
A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor
The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combination with other anti tumor therapy in subjects with solid tumor ; to evaluate HRS-4508 DLT, MTD and RP2D, to evaluate the incidence and…
- Trial name
- NCT07140393
- Testing
- HRS-4508+ Capecitabine, HRS-4508+ Trastuzumab, HRS-4508+ Trastuzumab+ Pertuzumab
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Advanced Gastroenteropancreatic Neuroendocrine Tumor
Gallium (68Ga) Edotreotide PET/CT for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors
This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium (68Ga) tracer.
- Trial name
- NCT06091748
- Testing
- 68Ga-DOTATOC
- Where
- China
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer
This is a study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HRS-6209 combined with other treatment regimens in breast cancer patients, and preliminarily observe its anti-tumor efficacy.
- Trial name
- NCT06974929
- Testing
- HRS-6209 Capsules, Letrozole Tablets, HRS-2189 Tablets
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Parkinson's Disease
A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations
The study is a multicenter, randomized, double-blind, double-dummy, active-controlled, Phase III clinical study. The aim of this trial is to evaluated the efficacy and assessed the safety of HRG2010 compared with a…
- Trial name
- NCT06596876
- Where
- China
- Volunteers
- 165 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Drug-drug Interaction,SHR3680
Drug-durg Interaction of SHR3680 With Digoxin, Rosuvastatin Calcium and Metformin Hydrochloride
The DDI study had been designed to investigate the effect of SHR3680 on the pharmacokinetics of digoxin, Rosuvastatin calcium and metformin hydrochloride.
- Trial name
- NCT04621669
- Testing
- SHR3680, digoxin, Rosuvastatin calcium
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
Phase I Study of HRS-3738 in Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-3738 in patients with recurrent and refractory Non-Hodgkin's lymphoma and multiple myeloma.
- Trial name
- NCT05363800
- Testing
- HRS-3738
- Where
- 3 sites in China
- Volunteers
- 74 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.