Clinical trials: sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.
Acute Ischemic Stroke AIS
A Phase II/III Clinical Study of SIM0811 in the Treatment of Acute Ischemic Stroke
The study will evaluate the efficacy and safety of SIM0811 in participants with acute ischemic stroke who are present within 4.5 to 24 hours since last known well. The main questions it aims to answer are: 1.
- Trial name
- NCT07903701
- Testing
- SIM0811 Dose Level A (Phase II), SIM0811 Dose Level B (Phase II), SIM0811 Dose Level C (Phase II)
- Volunteers
- 1,092 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Health, Subjective
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of SIM0811 Injection in Healthy Chinese Adult Participants
This study plans to set up 5 dose groups across 7 cohorts, including intravenous bolus plus infusion administration as well as intravenous bolus alone.
- Trial name
- NCT07345364
- Testing
- SIM0811
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Myelosuppression
A Phase III, Randomized, Double-blind, Multi-center Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer
The primary goal of this study is to evaluate the myelo-protective effect and safety of Trilaciclib in participants with limited stage small cell lung cancer (LS-SCLC) who are receiving concurrent chemo-radiotherapy.
- Trial name
- TRACER (NCT07881705)
- Testing
- Trilaciclib, Etoposide Injection, Carboplatin or Cisplatin Injection
- Where
- China
- Volunteers
- 106 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion
An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.
This research study is done to test the safety, effectiveness and pharmacokinetic characteristics of SIM1803-1A in patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations.
- Trial name
- NCT04671849
- Testing
- SIM1803-1A
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Relapsed or Refractory Multiple Myeloma
Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma
This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM).
- Trial name
- NCT06375044
- Testing
- SIM0500
- Where
- 16 sites in United States, China
- Volunteers
- 130 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Advanced Solid Tumors
Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Advanced Solid Tumors
This is a multicenter, open label, phase I trial to evaluate the safety and tolerability, pharmacokinetic/ pharmacodynamic characteristics and to assess the preliminary efficacy of SIM0348 as monotherapy or with sintilimab in…
- Trial name
- NCT05718219
- Testing
- SIM0348, SIM0348 + Sintilimab
- Where
- China
- Volunteers
- 49 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Neoplasms, Malignant
A Study of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
This study will evaluate the safety, of SIM0689 and how the body processes it, how it affects the body, and its early signs of activity against tumors when given alone to Adult Participants with Locally Advanced or Metastatic…
- Trial name
- NCT07660432
- Testing
- SIM0689 for Injection
- Where
- 6 sites in China
- Volunteers
- 472 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Locally Advanced or Metastatic Breast Cancer
A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)
This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+/HER2- locally advanced or…
- Trial name
- NCT06680921
- Testing
- SIM0270, Everolimus (Afinitor®), Exemestane tablets
- Where
- 57 sites in China
- Volunteers
- 482 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Histologically or Cytologically Confirmed Advanced Solid Tumors
A Phase I Study of SIM0532 in Adult Participants With Advanced Solid Tumors
an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of SIM0532 in participants with advanced solid tumors.
- Trial name
- NCT07749703
- Testing
- SIM0532 Tablets
- Where
- 6 sites in China
- Volunteers
- 346 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Advanced Solid Cancer
SIM0613 in Participants With Advanced Solid Tumors
This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic characteristics of SIM0613 in participants with locally advanced/ metastatic solid…
- Trial name
- SIM0613-101 (NCT07618260)
- Testing
- SIM0613
- Where
- China
- Volunteers
- 294 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Advanced Solid Tumors
Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors
This is an open-label, multicenter Phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0501 in participants with advanced solid tumors.
- Trial name
- NCT06331559
- Testing
- SIM0501 Tablets, SIM0501 in combination with olaparib
- Where
- China
- Volunteers
- 13 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Advanced Solid Tumours, Non-Small Cell Lung Cancer
First in Human Study of SIM0610 in Solid Tumors
This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic profile, and preliminary antitumor activity of SIM0610 in subjects with locally…
- Conditions
- Advanced Solid Tumours, Non-Small Cell Lung Cancer, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma
- Trial name
- SIM0610-101 (NCT07348211)
- Testing
- SIM0610 for Injection
- Where
- 7 sites in China
- Volunteers
- 260 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Healthy Adult Participants
An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants
This study is an open-label, fixed-sequence, two-period Phase 1 clinical trial in healthy adult Chinese participants with a total of 3 cohorts, 16-20 healthy adult Chinese participants are planned to be enrolled in each cohort.
- Trial name
- SIM0270-104 (NCT07357610)
- Testing
- SIM0270, itraconazole, Rifampin
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Refractory Metastatic Colorectal Cancer
A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer
The primary goal of Phase Ib Study is to evaluate the safety of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants.
- Trial name
- NCT07361003
- Testing
- Suvemcitug injection, trifluridine/tipiracil tablets
- Where
- 6 sites in China
- Volunteers
- 464 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Malignant Pleural Effusion
A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions
Malignant Pleural Effusion or Ascites is a common complication of malignant tumor, The objective of this study is to compare the efficacy of Endostar/cisplatin with placebo/cisplatin in patients with malignant pleural effusion or…
- Trial name
- NCT04914598
- Testing
- ENDOSTAR，cisplatin
- Where
- China
- Volunteers
- 290 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Advanced Solid Cancer
A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
This is an open-label,multicenter phase I study to evaluate the safety,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants with Locally Advanced/Metastatic Solid Tumors
- Trial name
- Solid Tumors (NCT07265921)
- Testing
- SIM0609 for injection, dose expansion of SIM0609 in CRC, dose expansion of SIM0609 in GC/GEJC cohort
- Where
- 6 sites in China
- Volunteers
- 232 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Atopic Dermatitis (AD)
A Phase 2 Study to Evaluate the Efficacy, Safety of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis
This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy, safety, and pharmacokinetics of SIM0278 in adult patients (18-75 years) with moderate to severe AD suitable for systemic…
- Trial name
- NCT07175233
- Testing
- SIM0278 injection
- Where
- 2 sites in China
- Volunteers
- 184 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Ovarian Cancer
A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer
The standard systemic treatment for ovarian cancer is platinum-based chemotherapy. However, majority of patients relapse and eventually progress to platinum resistance.
- Trial name
- NCT04908787
- Testing
- BD0801, Paclitaxel, Topotecan
- Where
- 55 sites in China
- Volunteers
- 421 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Healthy Volunteers
To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 in Chinese Healthy Subjects
This is a Phase 1, randomized, double-blind, placebo-controlled trial of SIM0278 in healthy subjects. The study will be conducted in 2 parts. Part 1 is single ascending dose study. Part 2 is multiple ascending dose study.
- Trial name
- NCT06022354
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Locally Advanced Solid Tumors
A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors
This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants with Locally Advanced/Metastatic Solid Tumors
- Trial name
- NCT07050459
- Testing
- SIM0686
- Where
- 10 sites in China
- Volunteers
- 220 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.