Clinical trials: sponsored by Betta Pharmaceuticals Co., Ltd.
Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC)
Study of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
Evaluate the safety and tolerability of BPI-572270 in adult patients with specific RAS mutant advanced solid tumors.
- Conditions
- Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors
- Trial name
- NCT07435038
- Testing
- BPI-572270
- Where
- 7 sites in Australia, China
- Volunteers
- 120 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
DDI (Drug-Drug Interaction)
Drug-Drug Interaction Study of Befotertinib Capsules in Healthy Participants.
This study adopts a single-center, open-label, same-subject sequential crossover clinical trial design, aiming to evaluate the effects of oral administration of rifampicin or itraconazole on the pharmacokinetic profiles of…
- Trial name
- NCT07809815
- Testing
- Befotertinib and rifampicin, Befotertinib and itraconazole
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Hepatic Impairment (HI)
Pharmacokinetic Study of Vorolanib Tablets in Trial Participants With Hepatic Impairment
This is a single-center, non-randomized, open-label, parallel-group, single-dose study designed to evaluate the safety and pharmacokinetic (PK) profile of vorolanib tablets in participants with hepatic impairment.
- Trial name
- NCT07809802
- Testing
- vorolanib
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
DDI (Drug-Drug Interaction)
Drug-Drug Interaction Study of Vorolanib Tablets in Healthy Participants
This study adopts a single-center, open-label, same-subject sequential crossover clinical trial design, aiming to evaluate the effects of oral administration of rifampicin or itraconazole on the pharmacokinetic profiles of…
- Trial name
- NCT07809789
- Testing
- vorolanib and rifampicin, vorolanib and itraconazole
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
NSCLC (Non-small Cell Lung Cancer)
Real World Study of Icotinib in Adjuvant Post Surgical Treatment for Stage IA2 High Risk to IB EGFR Mutant Non Small Cell Lung Cancer
This is a multicenter, retrospective, observational real-world study designed based on real-world data. Eligible medical institutions that meet standardized data quality requirements and have an adequate sample size will be…
- Trial name
- NCT07806604
- Testing
- Icotinib, Routine Observational
- Where
- 2 sites in China
- Volunteers
- 2,572 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non-Small Cell Lung Cancer With EGFR Mutation
A Phase I Study of CFT8919 in Patients With Advanced NSCLC
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of CFT8919 capsules in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying…
- Trial name
- NCT06641609
- Testing
- Dose-Escalation (Phase Ia) CFT8919 capsule, Dose-Expansion (Phase Ib) CFT8919 capsule, Cohort-Expansion (Phase Ic) CFT8919 capsule
- Where
- China
- Volunteers
- 166 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
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.
Solid Tumor, Non-Small Cell Lung Cancer
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
This is a multi-center, open-label, Phase I/II clinical study of MCLA-129 as monotherapy in patients with advanced solid tumors to evaluate the safety, pharmacokinetic characteristics and antitumor activity of MCLA-129.
- Conditions
- Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Colorectal Cancer
- Trial name
- NCT04930432
- Testing
- MCLA-129
- Where
- 87 sites in China
- Volunteers
- 400 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
NSCLC, Adjuvant Drug Therapy
Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI
Non-small cell lung cancer (NSCLC) accounts for over 85% of lung cancers. Approximately 30-40% of East Asian adenocarcinoma patients harbor EGFR mutations.
- Conditions
- NSCLC, Adjuvant Drug Therapy, EGFR
- Trial name
- NCT07181499
- Testing
- Befotertinib, Pemetrexed + Carboplatin
- Where
- 2 sites in China
- Volunteers
- 28 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non-Small Cell Lung Cancer, EGFR Gene Mutation
D-0316 Versus Icotinib in Patients With Locally Advanced or Metastatic EGFR Sensitising Mutation Positive NSCLC
To assess the efficacy and safety of D-0316 versus Icotinib, a standard of care epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), in patients with locally advanced or Metastatic Non Small Cell Lung Cancer…
- Trial name
- NCT04206072
- Testing
- D-0316 Capsule, Icotinib Hydrochloride Tablets
- Where
- 2 sites in China
- Volunteers
- 362 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non-Small Cell Lung Cancer
Study of MCLA-129 in the Treatment of Advanced Non-small Cell Lung Cancer with AGA and MET Amplification.
This is a multi-center, open-label, phase II clinical study of MCLA-129 as monotherapy in patients with advanced non-small cell lung cancer (NSCLC) with actionable gene alterations and MET amplification to evaluate the efficacy…
- Trial name
- NCT06885840
- Testing
- MCLA-129
- Where
- 20 sites in China
- Volunteers
- 100 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Advanced Solid Cancer
A Phase I Study of BPI-16350 in Patients with Advanced Solid Tumor
This was an open-label Phase I study. The primary objective of the study was to assess safety, tolerability, efficacy, and pharmacokinetic characteristics of BPI-16350 in different dose groups.
- Trial name
- NCT03791112
- Testing
- BPI-16350
- Where
- China
- Volunteers
- 54 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Advanced Solid Tumor
A Study of BPI-460372 in Advanced Solid Tumor Patients
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-460372 in solid tumor patients.
- Trial name
- NCT05789602
- Testing
- BPI-460372
- Where
- 11 sites in China
- Volunteers
- 82 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Advanced Solid Tumor, Lymphoma
A Phase 1 Study of BPI-371153 in Subjects with Advanced Solid Tumors or Relapsed/Refractory Lymphoma
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-371153, a PD-L1 Inhibitor, in patients with advanced solid tumors or…
- Conditions
- Advanced Solid Tumor, Lymphoma, NSCLC, HCC
- Trial name
- NCT05341557
- Testing
- BPI-371153
- Where
- 4 sites in China
- Volunteers
- 110 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non-Small Cell Lung Cancer
Befotertinib and Icotinib in Treatment-naive Patients With Advanced EGFR-Mutant Lung Cancer
This research study is studying a combination of two drugs as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation.
- Trial name
- NCT05007938
- Testing
- Icotinib, Befotertinib
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
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.
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, EGFR Sensitive Mutation
Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations
This multicenter, randomized, controlled, double-blind, double-simulated, Phase III study is designed to evaluate the efficacy and safety of Befotertinib compared with Icotinib as adjuvant treatment in EGFR-sensitive…
- Conditions
- Non-Small Cell Lung Cancer, EGFR Sensitive Mutation, Adjuvant Therapy
- Trial name
- NCT06041776
- Where
- 3 sites in China
- Volunteers
- 570 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non-Small Cell Lung Cancer、EGFR Sensitive Mutation
Study of MCLA-129 Combined With Befotertinib in the Treatment of Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation
To evaluate the safety and tolerance of MCLA-129 combined with Befotertinib in patients with advanced non-small cell lung cancer with EGFR-sensitive mutations.
- Trial name
- NCT06015568
- Testing
- MCLA-129: 1500mg or 2000mg IV Q2W, Befotertinib: 75 mg or 100 mg Po QD
- Where
- 3 sites in China
- Volunteers
- 172 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
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.