drugset / Trial / NCT03125746
A Study of LXI-15029 in Patients With Advanced Malignant Solid Tumors
Non-randomizedSingle-groupOpen-labelTreatment
Summary
1\. To evaluate the safety and tolerability of LXI-15029 in Chinese patients with advanced malignant solid tumors in monotherapy period, including confirmation of the maximum tolerated dose (MTD) of monotherapy. 2.To evaluate the safety and tolerability of LXI-15029 in Chinese postmenopausal patients with metastatic or locally advanced breast cancer with estrogen receptor (+) and human epidermal growth factor receptor 2 (-) in combined with Exemestane period , including confirmation of the maximum tolerated dose(MTD) of the combined therapy with Exemestane.
Timeline
- Start
- 2017-06-12
- Primary completion
- 2021-10-28
- Completion
- 2021-10-28
Publications
- Wang J, Gui L, Mu Y, Wang J, Chi Y, Liu Z, Li Q, Xu B. Phase I dose escalation study and pilot efficacy analysis of LXI-15029, a novel mTOR dual inhibitor, in Chinese subjects with advanced malignant solid tumors. BMC Cancer. 2023 Dec 6;23(1):1200. doi: 10.1186/s12885-023-11578-8.
- Zhang Q, Zhang Y, Chen Y, Qian J, Zhang X, Yu K. A Novel mTORC1/2 Inhibitor (MTI-31) Inhibits Tumor Growth, Epithelial-Mesenchymal Transition, Metastases, and Improves Antitumor Immunity in Preclinical Models of Lung Cancer. Clin Cancer Res. 2019 Jun 15;25(12):3630-3642. doi: 10.1158/1078-0432.CCR-18-2548. Epub 2019 Feb 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Exemestane | Small molecule | 25 mg | — |
| Subject | MTI-31 | Small molecule | 10 mg | Oral |
| Subject | MTI-31 | Small molecule | 20 mg | Oral |
| Subject | MTI-31 | Small molecule | 40 mg | Oral |
| Subject | MTI-31 | Small molecule | 60 mg | Oral |
| Subject | MTI-31 | Small molecule | 80 mg | Oral |
| Subject | MTI-31 | Small molecule | 110 mg | Oral |
| Subject | MTI-31 | Small molecule | 150 mg | Oral |