Clinical trials: sponsored by Betta Pharmaceuticals Co., Ltd.
Non-Small Cell Lung Cancer
X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
The main purpose of the study is to evaluate safety and efficacy of X-396(Ensartinib) capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between…
- Trial name
- NCT03215693
- Testing
- X-396 capsule
- Where
- 4 sites in China
- Volunteers
- 152 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Breast Cancer
A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer
This is a phase III clinical trial to evaluate the efficacy and safety of BPI-16350 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative locally…
- Trial name
- NCT05433480
- Testing
- BPI-16350, Fulvestrant
- Where
- 64 sites in China
- Volunteers
- 274 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Solid Tumor
BPB-101 in Subjects With Metastatic or Locally Advanced Solid Tumors
This is a multi-center, open-label, Phase I/II clinical study of BPB-101 as monotherapy in patients with advanced solid tumors to evaluate the safety, pharmacokinetic characteristics and antitumor activity of BPB-101.
- Trial name
- NCT05869240
- Testing
- BPB-101
- Where
- 4 sites in China
- Volunteers
- 388 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Healthy
A Food-Effect Study of BPI-16350 in Healthy Subjects
This study is intended to quantify the effect of food on the pharmacokinetics of BPI-16350. Subjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose of BPI-16350 on Day 1 in Period 1 and on Day…
- Trial name
- NCT05316259
- Testing
- BPI-16350
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Solid Tumor, Renal Cell Carcinoma
A Study of BPI-452080 in Subjects With Solid Tumors
This open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors
- Conditions
- Solid Tumor, Renal Cell Carcinoma, Von Hippel-Lindau Disease
- Trial name
- NCT05843305
- Testing
- BPI-452080
- Where
- 5 sites in China
- Volunteers
- 87 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Solid Tumor, Non-small Cell Lung Cancer
Phase 1 Study of BPI-442096 in Advanced Solid Tumor Patients
A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BPI-442096, a SHP2 inhibitor, in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer
- Trial name
- NCT05369312
- Testing
- BPI-442096
- Where
- 5 sites in China
- Volunteers
- 230 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Advanced Solid Tumor
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-21668
This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-21668 in solid tumor patients.
- Trial name
- NCT05341570
- Testing
- BPI-21668
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non-small Cell Lung Cancer
A Phase 1/2 Study of BPI-361175 in Subjects With Advanced Solid Tumors
This is a phase I/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of BPI-361175 tablets in patients with advanced solid tumors including advanced Non-small cell Lung cancer…
- Trial name
- NCT05329298
- Testing
- BPI-361175
- Where
- 8 sites in China
- Volunteers
- 90 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Malignant Neoplasms, Metastatic Cancer
A Phase 1，Open-label Study of BPI-421286 in Subjects With Advanced Solid Tumors
Evaluate the safety and tolerability of BPI-421286 in adult subjects with advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with advanced solid tumors.
- Trial name
- NCT05315180
- Testing
- BPI-421286
- Where
- 5 sites in China
- Volunteers
- 80 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Metastasis, Neoplasm
A Phase 1 Study of BPI-28592 in Subjects With Advanced Solid Tumors
This is an open-labe Phase I study of BPI-28592 for the treatment of patients with solid tumors
- Trial name
- NCT05302843
- Testing
- BPI-28592
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non-small Cell Lung Cancer
Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation
Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage IIA-IIIA…
- Trial name
- ICAPE (NCT02044328)
- Testing
- Icotinib
- Where
- China
- Volunteers
- 79 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Solid Tumors
Safety and Pharmacokinetics of BPI-9016M in Patients With Advanced Solid Tumors
BPI-9016M is a novel, highly potent and selective small-molecule inhibitor of c-Met/Axl kinase. In preclinical studies, it demonstrated strong activity in vitro and in vivo against c-Met/Axl kinase and its downstream signaling…
- Trial name
- NCT02478866
- Testing
- BPI-9016M
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non-small Cell Lung Cancer
Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC
The main objective of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics of BPI-9016M in patients with c-Met-dysregulated advanced NSCLC.
- Trial name
- NCT02929290
- Testing
- BPI-9016M
- Where
- 7 sites in China
- Volunteers
- 80 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non-small Cell Lung Cancer
Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation
Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage II-IIIA non-small…
- Trial name
- EVIDENCE (NCT02448797)
- Testing
- Icotinib, Chemotherapy
- Where
- 8 sites in China
- Volunteers
- 320 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Acute Myeloid Leukemia Leukemia
A Study of MRX2843 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
Patients will receive oral MRX2843 for 28 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations.
- Trial name
- NCT04946890
- Testing
- MRX2843
- Where
- China
- Volunteers
- 104 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Advanced or Metastatic Non-small Cell Lung
The Absorption, Metabolism and Excretion of [14C]D-0316 in Human
This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of [14C] D-0316 in healthy Chinese male subjects.
- Trial name
- NCT04464551
- Testing
- [14C]D-0316 suspension
- Where
- China
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
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, ROS1 Gene Rearrangement
X-396 Capsule in Advanced NSCLC Patients With ROS1 Gene Rearrangement
To assess treatment effectiveness and safety of oral X-396 capsule (Ensartinib) administered to Chinese patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a c-ROS Oncogene (ROS1)…
- Trial name
- NCT03608007
- Testing
- X-396 Capsule
- Where
- China
- Volunteers
- 69 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non Small Cell Lung Cancer, Brain Metastases
A Study to Determine the Efficiency For Brain Metastasis NSCLC Patients Treated With Icotinib Alone or Combined With Radiation Therapy
The purpose of this study is to evaluate the efficacy of icotinib alone or in combination with radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. The primary endpoint is overall survival .
- Trial name
- SMART (NCT04058704)
- Testing
- Icotinib, SRS/WBRT/HA-WBRT/SMART
- Where
- China
- Volunteers
- 296 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.