Sihuan Pharmaceutical 
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30 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
pirotinib (KBP-5209) / Sihuan Pharmaceutical
TRUMP, NCT03574402: Phase II Umbrella Study Directed by Next Generation Sequencing

Recruiting
2
400
RoW
Avitinib Maleate, AC0010, Afatinib, Giotrif, Crizotinib, Xalkori, X-396, ensartinib, Chidamide, Epidaza, Pyrotinib Maleate, SHR1258, AZD3759, Pirotinib, KBP-5209, Nimotuzumab, Pemetrexed, LY231514, Cisplatin, CDDP, Sintilimab, Gemcitabine, LY188011, Carboplatin, NSC 241240
Guangdong Association of Clinical Trials, Chinese Thoracic Oncology Group
Carcinoma, Non-Small-Cell Lung
12/22
12/24
PYTHON, NCT05885776: Preoperative Treatment of HR+/HER2+Breast Cancer With Pirotinib, Trastuzumab and AI Research

Recruiting
2
48
RoW
Pyrrolidine、trastuzumab、AI, OFS (OFS includes bilateral eggs Nest removal or GnRHa drugs)
Tianjin Medical University Cancer Institute and Hospital
Breast Cancer
03/24
09/25
KBP-5074 / Sihuan Pharmaceutical
Clarion-CKD, NCT04968184 / 2021-003636-88: Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (CKD)

Terminated
3
652
Europe, Canada, US, RoW
Placebo, KBP-5074
KBP Biosciences, KBP BioSciences PTE. Ltd.
Chronic Kidney Diseases
01/24
07/24
SLC-391 / SignalChem Lifesci
KEYNOTE-C62, NCT05860296: Testing Experimental Anti-cancer Drug SLC-391 with an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers

Recruiting
1/2
92
Canada, US
SLC-391, pembrolizumab, KEYTRUDA®
SignalChem Lifesciences Corporation, Merck Sharp & Dohme LLC
Lung Cancer, Nonsmall Cell, Lung Cancer Stage IV, Lung Cancer Metastatic
09/26
09/28
NCT05740917: To Evaluate the Phase I Clinical Study of XZB-0004 in Patients With AML and MDS

Not yet recruiting
1
82
RoW
XZB-0004
Xuanzhu Biopharmaceutical Co., Ltd.
AML, MDS
02/23
02/23
NCT03990454: Safety Study of SLC-391 in Subjects With Solid Tumors

Completed
1
35
Canada
SLC-391
SignalChem Lifesciences Corporation
Solid Tumor
06/23
06/23
NCT05772455: A Study of XZB-0004 in Patients With Solid Tumors

Recruiting
1
128
RoW
XZB-0004
Xuanzhu Biopharmaceutical Co., Ltd.
Advanced Solid Tumor, NSCLC
06/25
02/27
zifanocycline (KBP-7072) / Sihuan Pharmaceutical
NCT05507463: Study of KBP-7072 in Healthy Male and Female Subjects

Completed
1
56
US
KBP-7072, Placebo
KBP Biosciences, Parexel
Healthy Subjects
06/23
06/23
NG-350A / Akamis Bio
REVOLUTION, NCT04787991: Exploratory Platform Trial to Evaluate Immunotherapy Combinations With Chemotherapy for the Treatment of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

Active, not recruiting
1
45
US
Nivolumab (Cohort A), Opdivo, Ipilimumab (Cohort A, B and C), Yervoy, Hydroxychloroquine (HCQ) (Cohort B), Plaquenil, Nab-paclitaxel (nP) (Cohort A, B and C), Abraxane, Gemcitabine (gem) (Cohort A, B and C), Gemzar, NG350A (Cohort C)
Cancer Insight, LLC, Bristol-Myers Squibb, Cancer Research Institute, New York City, Akamis Bio
Metastatic Pancreatic Adenocarcinoma
10/24
01/25
FORTIFY, NCT05165433: Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours

Active, not recruiting
1
198
Europe, US
NG-350A plus Pembrolizumab, KEYTRUDA®
Akamis Bio, Merck Sharp & Dohme LLC
Epithelial Tumor, Metastatic Cancer
03/25
05/25
FORTRESS, NCT06459869: NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

Recruiting
1
30
Europe, US
NG-350A IV administration, Capecitabine oral administration, Radiotherapy
Akamis Bio
Locally Advanced Rectal Cancer (LARC)
02/26
01/29
Xuan Yue Ning (bireociclib) / Sihuan Pharmaceutical
BRIGHT-2, NCT05077449: A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer

Active, not recruiting
3
300
RoW
XZP-3287+Fulvestrant, Placebo + Fulvestrant
Xuanzhu Biopharmaceutical Co., Ltd.
Advanced Breast Cancer
02/24
11/29
NCT05257395: A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer

Active, not recruiting
3
397
RoW
XZP-3287+ Letrozole/Anastrozole, Placebo + Letrozole/Anastrozole
Xuanzhu Biopharmaceutical Co., Ltd.
Advanced Breast Cancer
12/25
09/30
BRIGHT-1, NCT04539496: A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors

Active, not recruiting
1/2
402
RoW
XZP-3287, XZP-3287;Letrozole;Anastrozole;Fulvestrant
Sihuan Pharmaceutical Holdings Group Ltd.
Metastasis Solid Tumors, Advanced Breast Cancer
07/23
12/25
NCT04951765: Effect of Food on the Pharmacokinetics of XZP-3287 in Healthy Subjects

Recruiting
1
24
RoW
XZP-3287
Xuanzhu Biopharmaceutical Co., Ltd.
Healthy
08/21
12/21
NCT04951713: Effect of Clarithromycin and Rifampicin on the Pharmacokinetics of XZP-3287 in Healthy Subjects

Recruiting
1
60
RoW
XZP-3287 combined with clarithromycin, XZP-3287 combined with rifampicin
Xuanzhu Biopharmaceutical Co., Ltd.
Healthy
09/21
12/21
NCT05478109: A Clinical Trial of XZP-3287 for Material Balance

Not yet recruiting
1
10
RoW
[14C]XZP-3287
Xuanzhu Biopharmaceutical Co., Ltd.
Healthy Male Subjects
01/23
01/23
XZP-5955 / Sihuan Pharmaceutical
NCT04996121: A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors

Recruiting
1/2
360
RoW
XZP-5955 tablets
Xuanzhu Biopharmaceutical Co., Ltd.
Locally Advanced or Metastatic Solid Tumors, Locally Advanced or Metastatic Non-small Cell Lung Cancer
09/25
06/27
dexitinib (XZP-3621) / Sihuan Pharmaceutical
NCT05204628: A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib

Not yet recruiting
3
238
RoW
XZP-3621, Crizotinib
Xuanzhu Biopharmaceutical Co., Ltd.
Non-small Cell Lung Cancer
05/25
07/25
NCT05482087: A Study of XZP-3621 in Chinese Patients With ALK Positive NSCLC

Not yet recruiting
2
190
RoW
XZP-3621
Xuanzhu Biopharmaceutical Co., Ltd.
ALK-positive NSCLC
05/25
07/25
NCT05034120: Food Effect and Mass Balance Study of XZP-3621 Tablets

Completed
1
34
RoW
XZP-3621
Xuanzhu Biopharmaceutical Co., Ltd.
Healthy
03/22
03/22
NCT05055232: A Phase I Study of XZP-3621 in Chinese Patients With ALK or ROS1 Rearrangement Non-small Cell Lung Cancer

Recruiting
1
120
RoW
XZP-3621
Xuanzhu Biopharmaceutical Co., Ltd.
ROS1 Rearrangement Non-small Cell Lung Cancer, ALK Rearrangement Non-small Cell Lung Cancer
03/23
09/23
NCT05586568: Drug-drug Interaction Study of XZP-3621 Tablet

Not yet recruiting
1
72
RoW
XZP-3621 tablet and itraconazole oral liquid (for Arm1), XZP-3621 tablet and Rifampicin capsules (For Arm 2), XZP-3621 tablet and esomeprazole tablet (For Arm3)
Xuanzhu Biopharmaceutical Co., Ltd.
Healthy Subjects
04/23
08/23
NCT05836805: A Study of the Absorption, Metabolism and Excretion of [14C]XZP-3621 in Human

Not yet recruiting
1
6
RoW
[14C]XZP-3621
Xuanzhu Biopharmaceutical Co., Ltd.
Healthy Volunteers
08/23
09/23
XZP-6019 / Sihuan Pharmaceutical
NCT05063968: A Clinical Trial of XZP-6019 Tablets in Healthy Subjects

Not yet recruiting
1
120
RoW
XZP-6019 tablet, Placebo
Xuanzhu Biopharmaceutical Co., Ltd.
Non-alcoholic Fatty Liver Disease
09/22
09/22
XZP-5809 / Sihuan Pharmaceutical
NCT04622072: XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer

Terminated
1/2
21
RoW
XZP-5809-TT1 Tablet
Sihuan Pharmaceutical Holdings Group Ltd.
Non Small Cell Lung Cancer
05/21
04/22
anaprazole / Sihuan Pharmaceutical
NCT07010107: A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.

Not yet recruiting
3
500
RoW
Anaprazole + Rabeprazole placebo, Rabeprazole + Anaprazole placebo
Xuanzhu Biopharmaceutical Co., Ltd.
Reflux Esophagitis (RE)
04/26
08/26
NCT05604261: A Study of Anaprazole Sodium Enteric-coated Tablets in the Treatment of Reflux Esophagitis

Not yet recruiting
2
156
RoW
Anaprazole sodium 40 mg, Anaprazole sodium 60 mg, Rabeprazole sodium 20 mg
Xuanzhu Biopharmaceutical Co., Ltd.
Reflux Esophagitis, Gastroesophageal Reflux, Esophagitis, Esophageal Motility Disorders, Deglutition Disorders, Esophageal Diseases, Gastrointestinal Diseases
07/23
03/24
XZP-5610 / Sihuan Pharmaceutical
NCT04913090: A Phase I Clinical Trial of XZP-5610 Tablets in Healthy Subjects

Recruiting
1
112
RoW
XZP-5610 Tablet (for Part A), 5610, Placebo to match XZP-5610 Tablet (for Part A), 5610 Placebo, XZP-5610 Tablet (for Part B), Placebo to match XZP-5610 Tablet (for Part B), XZP-5610 Tablet （for "Part C1"）, XZP-5610 Tablet for "Part C2"
Xuanzhu Biopharmaceutical Co., Ltd.
Nonalcoholic Steatohepatitis (NASH)
03/22
03/22
XZP-KM257 / Sihuan Pharmaceutical
NCT05320874: A Study of KM257 in Patients With Advanced HER2-positive or Expressing Solid Tumors.

Not yet recruiting
1
232
RoW
KM257 Bispecific antibody
Xuanzhu Biopharmaceutical Co., Ltd.
Advanced Solid Tumor
06/24
11/26
KM-501 / Sihuan Pharmaceutical
No trials found
XZP-P107 / Sihuan Pharmaceutical
No trials found
KM254-ADC / Sihuan Pharmaceutical
No trials found
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
pirotinib (KBP-5209) / Sihuan Pharmaceutical
TRUMP, NCT03574402: Phase II Umbrella Study Directed by Next Generation Sequencing

Recruiting
2
400
RoW
Avitinib Maleate, AC0010, Afatinib, Giotrif, Crizotinib, Xalkori, X-396, ensartinib, Chidamide, Epidaza, Pyrotinib Maleate, SHR1258, AZD3759, Pirotinib, KBP-5209, Nimotuzumab, Pemetrexed, LY231514, Cisplatin, CDDP, Sintilimab, Gemcitabine, LY188011, Carboplatin, NSC 241240
Guangdong Association of Clinical Trials, Chinese Thoracic Oncology Group
Carcinoma, Non-Small-Cell Lung
12/22
12/24
PYTHON, NCT05885776: Preoperative Treatment of HR+/HER2+Breast Cancer With Pirotinib, Trastuzumab and AI Research

Recruiting
2
48
RoW
Pyrrolidine、trastuzumab、AI, OFS (OFS includes bilateral eggs Nest removal or GnRHa drugs)
Tianjin Medical University Cancer Institute and Hospital
Breast Cancer
03/24
09/25
KBP-5074 / Sihuan Pharmaceutical
Clarion-CKD, NCT04968184 / 2021-003636-88: Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (CKD)

Terminated
3
652
Europe, Canada, US, RoW
Placebo, KBP-5074
KBP Biosciences, KBP BioSciences PTE. Ltd.
Chronic Kidney Diseases
01/24
07/24
SLC-391 / SignalChem Lifesci
KEYNOTE-C62, NCT05860296: Testing Experimental Anti-cancer Drug SLC-391 with an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers

Recruiting
1/2
92
Canada, US
SLC-391, pembrolizumab, KEYTRUDA®
SignalChem Lifesciences Corporation, Merck Sharp & Dohme LLC
Lung Cancer, Nonsmall Cell, Lung Cancer Stage IV, Lung Cancer Metastatic
09/26
09/28
NCT05740917: To Evaluate the Phase I Clinical Study of XZB-0004 in Patients With AML and MDS

Not yet recruiting
1
82
RoW
XZB-0004
Xuanzhu Biopharmaceutical Co., Ltd.
AML, MDS
02/23
02/23
NCT03990454: Safety Study of SLC-391 in Subjects With Solid Tumors

Completed
1
35
Canada
SLC-391
SignalChem Lifesciences Corporation
Solid Tumor
06/23
06/23
NCT05772455: A Study of XZB-0004 in Patients With Solid Tumors

Recruiting
1
128
RoW
XZB-0004
Xuanzhu Biopharmaceutical Co., Ltd.
Advanced Solid Tumor, NSCLC
06/25
02/27
zifanocycline (KBP-7072) / Sihuan Pharmaceutical
NCT05507463: Study of KBP-7072 in Healthy Male and Female Subjects

Completed
1
56
US
KBP-7072, Placebo
KBP Biosciences, Parexel
Healthy Subjects
06/23
06/23
NG-350A / Akamis Bio
REVOLUTION, NCT04787991: Exploratory Platform Trial to Evaluate Immunotherapy Combinations With Chemotherapy for the Treatment of Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

Active, not recruiting
1
45
US
Nivolumab (Cohort A), Opdivo, Ipilimumab (Cohort A, B and C), Yervoy, Hydroxychloroquine (HCQ) (Cohort B), Plaquenil, Nab-paclitaxel (nP) (Cohort A, B and C), Abraxane, Gemcitabine (gem) (Cohort A, B and C), Gemzar, NG350A (Cohort C)
Cancer Insight, LLC, Bristol-Myers Squibb, Cancer Research Institute, New York City, Akamis Bio
Metastatic Pancreatic Adenocarcinoma
10/24
01/25
FORTIFY, NCT05165433: Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours

Active, not recruiting
1
198
Europe, US
NG-350A plus Pembrolizumab, KEYTRUDA®
Akamis Bio, Merck Sharp & Dohme LLC
Epithelial Tumor, Metastatic Cancer
03/25
05/25
FORTRESS, NCT06459869: NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

Recruiting
1
30
Europe, US
NG-350A IV administration, Capecitabine oral administration, Radiotherapy
Akamis Bio
Locally Advanced Rectal Cancer (LARC)
02/26
01/29
Xuan Yue Ning (bireociclib) / Sihuan Pharmaceutical
BRIGHT-2, NCT05077449: A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer

Active, not recruiting
3
300
RoW
XZP-3287+Fulvestrant, Placebo + Fulvestrant
Xuanzhu Biopharmaceutical Co., Ltd.
Advanced Breast Cancer
02/24
11/29
NCT05257395: A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer

Active, not recruiting
3
397
RoW
XZP-3287+ Letrozole/Anastrozole, Placebo + Letrozole/Anastrozole
Xuanzhu Biopharmaceutical Co., Ltd.
Advanced Breast Cancer
12/25
09/30
BRIGHT-1, NCT04539496: A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors

Active, not recruiting
1/2
402
RoW
XZP-3287, XZP-3287;Letrozole;Anastrozole;Fulvestrant
Sihuan Pharmaceutical Holdings Group Ltd.
Metastasis Solid Tumors, Advanced Breast Cancer
07/23
12/25
NCT04951765: Effect of Food on the Pharmacokinetics of XZP-3287 in Healthy Subjects

Recruiting
1
24
RoW
XZP-3287
Xuanzhu Biopharmaceutical Co., Ltd.
Healthy
08/21
12/21
NCT04951713: Effect of Clarithromycin and Rifampicin on the Pharmacokinetics of XZP-3287 in Healthy Subjects

Recruiting
1
60
RoW
XZP-3287 combined with clarithromycin, XZP-3287 combined with rifampicin
Xuanzhu Biopharmaceutical Co., Ltd.
Healthy
09/21
12/21
NCT05478109: A Clinical Trial of XZP-3287 for Material Balance

Not yet recruiting
1
10
RoW
[14C]XZP-3287
Xuanzhu Biopharmaceutical Co., Ltd.
Healthy Male Subjects
01/23
01/23
XZP-5955 / Sihuan Pharmaceutical
NCT04996121: A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors

Recruiting
1/2
360
RoW
XZP-5955 tablets
Xuanzhu Biopharmaceutical Co., Ltd.
Locally Advanced or Metastatic Solid Tumors, Locally Advanced or Metastatic Non-small Cell Lung Cancer
09/25
06/27
dexitinib (XZP-3621) / Sihuan Pharmaceutical
NCT05204628: A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib

Not yet recruiting
3
238
RoW
XZP-3621, Crizotinib
Xuanzhu Biopharmaceutical Co., Ltd.
Non-small Cell Lung Cancer
05/25
07/25
NCT05482087: A Study of XZP-3621 in Chinese Patients With ALK Positive NSCLC

Not yet recruiting
2
190
RoW
XZP-3621
Xuanzhu Biopharmaceutical Co., Ltd.
ALK-positive NSCLC
05/25
07/25
NCT05034120: Food Effect and Mass Balance Study of XZP-3621 Tablets

Completed
1
34
RoW
XZP-3621
Xuanzhu Biopharmaceutical Co., Ltd.
Healthy
03/22
03/22
NCT05055232: A Phase I Study of XZP-3621 in Chinese Patients With ALK or ROS1 Rearrangement Non-small Cell Lung Cancer

Recruiting
1
120
RoW
XZP-3621
Xuanzhu Biopharmaceutical Co., Ltd.
ROS1 Rearrangement Non-small Cell Lung Cancer, ALK Rearrangement Non-small Cell Lung Cancer
03/23
09/23
NCT05586568: Drug-drug Interaction Study of XZP-3621 Tablet

Not yet recruiting
1
72
RoW
XZP-3621 tablet and itraconazole oral liquid (for Arm1), XZP-3621 tablet and Rifampicin capsules (For Arm 2), XZP-3621 tablet and esomeprazole tablet (For Arm3)
Xuanzhu Biopharmaceutical Co., Ltd.
Healthy Subjects
04/23
08/23
NCT05836805: A Study of the Absorption, Metabolism and Excretion of [14C]XZP-3621 in Human

Not yet recruiting
1
6
RoW
[14C]XZP-3621
Xuanzhu Biopharmaceutical Co., Ltd.
Healthy Volunteers
08/23
09/23
XZP-6019 / Sihuan Pharmaceutical
NCT05063968: A Clinical Trial of XZP-6019 Tablets in Healthy Subjects

Not yet recruiting
1
120
RoW
XZP-6019 tablet, Placebo
Xuanzhu Biopharmaceutical Co., Ltd.
Non-alcoholic Fatty Liver Disease
09/22
09/22
XZP-5809 / Sihuan Pharmaceutical
NCT04622072: XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer

Terminated
1/2
21
RoW
XZP-5809-TT1 Tablet
Sihuan Pharmaceutical Holdings Group Ltd.
Non Small Cell Lung Cancer
05/21
04/22
anaprazole / Sihuan Pharmaceutical
NCT07010107: A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.

Not yet recruiting
3
500
RoW
Anaprazole + Rabeprazole placebo, Rabeprazole + Anaprazole placebo
Xuanzhu Biopharmaceutical Co., Ltd.
Reflux Esophagitis (RE)
04/26
08/26
NCT05604261: A Study of Anaprazole Sodium Enteric-coated Tablets in the Treatment of Reflux Esophagitis

Not yet recruiting
2
156
RoW
Anaprazole sodium 40 mg, Anaprazole sodium 60 mg, Rabeprazole sodium 20 mg
Xuanzhu Biopharmaceutical Co., Ltd.
Reflux Esophagitis, Gastroesophageal Reflux, Esophagitis, Esophageal Motility Disorders, Deglutition Disorders, Esophageal Diseases, Gastrointestinal Diseases
07/23
03/24
XZP-5610 / Sihuan Pharmaceutical
NCT04913090: A Phase I Clinical Trial of XZP-5610 Tablets in Healthy Subjects

Recruiting
1
112
RoW
XZP-5610 Tablet (for Part A), 5610, Placebo to match XZP-5610 Tablet (for Part A), 5610 Placebo, XZP-5610 Tablet (for Part B), Placebo to match XZP-5610 Tablet (for Part B), XZP-5610 Tablet （for "Part C1"）, XZP-5610 Tablet for "Part C2"
Xuanzhu Biopharmaceutical Co., Ltd.
Nonalcoholic Steatohepatitis (NASH)
03/22
03/22
XZP-KM257 / Sihuan Pharmaceutical
NCT05320874: A Study of KM257 in Patients With Advanced HER2-positive or Expressing Solid Tumors.

Not yet recruiting
1
232
RoW
KM257 Bispecific antibody
Xuanzhu Biopharmaceutical Co., Ltd.
Advanced Solid Tumor
06/24
11/26
KM-501 / Sihuan Pharmaceutical
No trials found
XZP-P107 / Sihuan Pharmaceutical
No trials found
KM254-ADC / Sihuan Pharmaceutical
No trials found

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