Clinical trials: Ensartinib
Solid Advanced Tumor
Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors.
This is a multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of the anti-EGFR/c-Met bispecific antibody MCLA-129 in combination with Ensartinib hydrochloride in…
- Trial name
- NCT07448116
- Testing
- MCLA-129, Ensartinib
- Where
- China
- Volunteers
- 164 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non-Small Cell Lung Cancer, ALK Gene Rearrangement Positive
Expanded Access to Ensartinib for Participants With ALK+ NSCLC
This is an open-label, multicenter, intermediate-sized expanded access treatment protocol to the existing IND 111,695 for ensartinib (X-396).
- Trial name
- NCT04146571
- Testing
- Ensartinib
- Where
- 4 sites in United States
- Sponsor
- Xcovery Holdings, Inc.
Non-small Cell Lung Cancer
Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer
This double-blind, randomized, placebo-controlled, multicenter, Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell…
- Trial name
- NCT05341583
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 202 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non-small Cell Lung Cancer
eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no…
- Trial name
- NCT02767804
- Testing
- X-396 (ensartinib), crizotinib
- Where
- 72 sites in United States, Argentina and 18 more
- Volunteers
- 290 people
- Sponsor
- Xcovery Holdings, Inc.
Lung Cancer, Nonsmall Cell, Brain Metastases
X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases
To assess efficacy and safety of oral X-396 (Ensartinib) capsule in Chinese ALK-positive NSCLC patients with brain metastases, eligible patients will be enrolled with objective responses being primary outcome measures.
- Trial name
- NCT04415320
- Testing
- X-396(Ensartinib)
- Where
- China
- Volunteers
- 37 people
- 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.
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.
Advanced Solid Tumors, Non-small Cell Lung Cancer
Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer
This is the first human study to use X-396 (ensartinib), a drug being developed for treatment of advanced cancers. The initial purpose of the study is to determine the largest amount of X-396 that can be safely given to humans…
- Trial name
- NCT01625234
- Testing
- Phase I: X-396 (ensartinib), Phase II: X-396 (ensartinib)
- Where
- 14 sites in United States
- Volunteers
- 131 people
- Sponsor
- Xcovery Holdings, Inc.
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.
Solid Tumor, Non-Small Cell Lung Cancer Metastatic
Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK
This study is aimed to determine the maximum tolerated dose of ensartinib, an oral ALK inhibitor in Chinese patients with ALK-positive non-small cell lung cancer
- Trial name
- NCT02959619
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 48 people
- 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.
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.