Clinical trials: Ensartinib
ALK-positive, Locally Advanced or Metastatic (TNM Stage IIIB-IV) Non-small Cell Lung Cancer That Has Developed Resistance to Prior Treatment With Lorlatinib
Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive NSCLC
ALK TKIs, particularly second- and third-generation ALK TKIs, have significantly improved progression-free survival (PFS) in patients with advanced ALK-positive non-small cell lung cancer (NSCLC).
- Trial name
- NCT07671560
- Testing
- Combined group of ensatinib and arotinib
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Qiming Wang
Bioequivalency
A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions
This is an open-label, Phase I single dose 2-part, crossover bioequivalence study under fasted conditions. The trial is designed to evaluate the pharmacokinetic parameters between single doses of 100mg ensartinib capsules…
- Trial name
- NCT05665283
- Testing
- Ensartinib Hydrochloride
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Xcovery Holdings, Inc.
ALK-POSITIVE NSCLC
The Absorption, Metabolism and Excretion of [14C]Ensartinib in Human
This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of [14C] Ensartinib in healthy Chinese male subjects.
- Trial name
- NCT03804541
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Healthy
A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers
The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib.
- Trial name
- NCT06492525
- Testing
- Ensartinib, Rifampicin, Itraconazole
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non-Small Cell Lung Cancer
A Study to Investigate the Food Effect on the Pharmacokinetics of Ensartinib Capsules in Chinese Healthy Volunteers.
The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules.
- Trial name
- NCT03510611
- Testing
- Ensartinib with fed or fasting
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Lung Cancer
Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers
The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers.
- Trial name
- NCT03536481
- Testing
- ensartinib capsules (test product), ensartinib capsules (reference product)
- Where
- China
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.