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- unecritinib (TQ-B3101) / Sino Biopharm
Safety, Efficacy, and Pharmacokinetics of Unecritinib (TQ-B3101) in Pediatric Patients with Relapsed/Refractory Anaplastic Lymphoma Kinase Positive Anaplastic Large Cell Lymphoma: A Phase I Study (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_6718;
Conclusion Unecritinib showed a good safety profile and promising efficacy in pediatric patients with R/R ALK+ ALCL. The RP2D of unecritinib is 300 mg BID for pediatric patients older than 10 years.
- unecritinib (TQ-B3101) / Sino Biopharm
Unecritinib in Patients with ROS1 Positive Advanced Non-Small Cell Lung Cancer: Updated Results from a Phase II Trial (20D) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_976;
P2
Conclusions : In this updated analysis with longer follow-up, unecritinib continued to show the clinical benefit and manageable toxicities in ROS1-positive advanced NSCLC patients. Further analysis of OS will be performed as survival data mature.
- || imatinib / Generic mfg., Xalkori (crizotinib) / Pfizer, unecritinib (TQ-B3101) / Sino Biopharm
PK/PD data, Preclinical, Journal: Simultaneous determination of unecritinib (TQ-B3101) and its active metabolite crizotinib in rat plasma by LC-MS/MS?An application to pharmacokinetic studies. (Pubmed Central) - Jun 9, 2024
The precision, accuracy and stabilities all met the acceptance criteria. The pharmacokinetic study indicated that TQ-B3101 was rapidly hydrolyzed to crizotinib with the elimination half-life of 1.11?h after a single gavage administration of 27?mg/kg to Sprague-Dawley rats, and the plasma exposure of TQ-B3101 was only 2.98% of that of crizotinib.
- TQ-B3101 / Sino Biopharm
Phase I Study of Tq-B3101 in Pediatric Patients with Relapsed/Refractory Anaplastic Lymphoma Kinase Positive Anaplastic Large Cell Lymphoma (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_4321;
P1/2, P1b,
Responses were durable and ongoing, and treatment was well tolerated. Further investigation is warranted to find the MTD and confirm the efficacy of TQ-B3101.
- TQ-B3101 / Sino Biopharm
The efficacy and safety of TQ-B3101 monotherapy in the first line treatment in patients with ROS1 positive non-small cell lung cancer (Club A [VIRTUAL]) - Feb 19, 2022 - Abstract #ELCC2022ELCC_223;
P2
Most common TRAEs were AST increased (73.9%), ALT increased (72.1%), emesis (63.1%), neutrophils count decrease (56.8%), leukocyte count decrease (52.3%), sinus bradycardia (52.3%), and diarrhea (43.2%). Conclusions For the first-line treatment of ROS1-positive locally advanced or metastatic NSCLC patients, TQ-B3101 showed the promising efficacy with a manageable safety profile, offering a new first-line therapeutic strategy.
- || TQ-B3101 / Sino Biopharm
PK/PD data, Journal: Population Pharmacokinetic Modeling and Simulation of TQ-B3101 to Inform Dosing in Pediatric Patients With Solid Tumors. (Pubmed Central) - Feb 5, 2022
The projected exposure of TQ-B3101M in virtual pediatric population following the body surface area tiered dosing regimen was similar to that in children pediatric patients after the recommended pediatric dose of crizotinib (280 mg/m2 twice daily), an analog of TQ-B3101M. A population pharmacokinetic model was developed to provide optimal dose of regimen for further development of TQ-B3101 in pediatric patients with anaplastic large cell lymphoma.
- || unecritinib (TQ-B3101) / Sino Biopharm
Trial completion, Trial completion date: A Pharmacokinetic Study of TQB3101 in Chinese Healthy Subjects (clinicaltrials.gov) - Jan 21, 2022
P1, N=16, Completed, Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A population pharmacokinetic model was developed to provide optimal dose of regimen for further development of TQ-B3101 in pediatric patients with anaplastic large cell lymphoma. Not yet recruiting --> Completed | Trial completion date: Dec 2021 --> Jul 2021
- || unecritinib (TQ-B3101) / Sino Biopharm
New P1 trial: A Pharmacokinetic Study of TQB3101 in Chinese Healthy Subjects (clinicaltrials.gov) - Mar 17, 2021
P1, N=16, Not yet recruiting, Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- ||| unecritinib (TQ-B3101) / Sino Biopharm
Enrollment open, Metastases: A Study of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor (clinicaltrials.gov) - Aug 17, 2020
P2, N=200, Recruiting, Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Not yet recruiting --> Completed | Trial completion date: Dec 2021 --> Jul 2021 Not yet recruiting --> Recruiting
- |||| unecritinib (TQ-B3101) / Sino Biopharm
New P2 trial, Metastases: A Study of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor (clinicaltrials.gov) - Jun 1, 2020
P2, N=200, Not yet recruiting, Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Xalkori (crizotinib) / Pfizer
[VIRTUAL] A phase I study to evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity of TQ-B3101. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_5648;
P2
Recommended phase II dose (RP2D) might be 300mg BID according longtime safety data. Further anti-tumor research in pts with ROS1+ is under going as multicenter clinical study in China.
- || unecritinib (TQ-B3101) / Sino Biopharm
New P2 trial: TQ-B3101-II-02: A Study of TQ-B3101 in Subjects With Relapsed or Refractory Anaplastic Large Cell Lymphoma (ALCL) (clinicaltrials.gov) - Mar 12, 2020
P2, N=30, Recruiting, Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- | unecritinib (TQ-B3101) / Sino Biopharm
Enrollment open: Safety and Efficacy Study of TQ-B3101 in Patients With ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - Aug 14, 2019
P2, N=111, Recruiting, Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Further anti-tumor research in pts with ROS1+ is under going as multicenter clinical study in China. Not yet recruiting --> Recruiting
- |||| unecritinib (TQ-B3101) / Sino Biopharm
New P2 trial: Safety and Efficacy Study of TQ-B3101 in Patients With ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - Jun 2, 2019
P2, N=111, Not yet recruiting, Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- unecritinib (TQ-B3101) / Sino Biopharm
Enrollment open, Trial initiation date, Metastases: A Phase I Study of TQ-B3101 on Tolerance and Pharmacokinetics (clinicaltrials.gov) - Sep 18, 2017
P1, N=20, Recruiting, Sponsor: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Feb 2017 --> Jul 2017
- | unecritinib (TQ-B3101) / Sino Biopharm
New P1 trial, Metastases: A Phase I Study of TQ-B3101 on Tolerance and Pharmacokinetics (clinicaltrials.gov) - Jan 12, 2017
P1, N=20, Not yet recruiting, Sponsor: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd