Phosphatidylinositol 3-kinase family inhibitors, mTORC1 inhibitors(Mammalian target of Rapamycin (mTORC1) inhibitors), mTORC2 inhibitors(mTOR Complex 2 inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Advanced cancerAdvanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Foreland Pharma Co Ltd

Active Organization

Foreland Pharma Co Ltd

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

RegulationSpecial Review Project (CN)

Clinical Trials associated with FP-208

CTR20180683 / CompletedPhase 1

评估FP-208单药治疗晚期实体肿瘤患者的安全性、耐受性、药代动力学特征和初步疗效的开放性、剂量递增I期临床研究

[Translation] An open-label, dose-escalation Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of FP-208 monotherapy in patients with advanced solid tumors

主要目的是评估FP-208治疗晚期实体肿瘤患者的安全性和药代动力学特征，次要目的是初步评估抗肿瘤活性，并探索生物标志物pS6药物和疗效的关系。

[Translation]

The primary objective is to evaluate the safety and pharmacokinetic characteristics of FP-208 in the treatment of patients with advanced solid tumors. The secondary objective is to preliminarily evaluate the anti-tumor activity and explore the relationship between the biomarker pS6 drug and efficacy.

Start Date16 Jan 2019

Sponsor / Collaborator

Foreland Pharma Co Ltd

100 Clinical Results associated with FP-208

100 Translational Medicine associated with FP-208

100 Patents (Medical) associated with FP-208

Literatures (Medical) associated with FP-208

01 Mar 2020·BioanalysisQ4 · MEDICINE

UHPLC–MS/MS Method to Determine FP-208 in Human Plasma and its Application to a Pharmacokinetic Study

Q4 · MEDICINE

Article

Author: Wang, Huanhuan ; Zhao, Qian ; Jiang, Ji ; Hu, Pei ; Wang, Zhanqing ; Wang, Teng ; Du, Zhenjian

Aim: FP-208 is a novel and effective small-molecule inhibitor blocking the mammalian target of rapamycin complex-1/mammalian target of rapamycin complex-2/PI3Ka. To investigate the pharmacokinetic profile of FP-208, a rapid and reliable analytical method was needed to be established to determine FP-208 in the plasma of patients with solid tumors. Materials & methods: FP208 was separated on a charged surface hybrid (CSH) C18 column (2.1 mm × 50 mm, 1.7 μm) after the plasma samples were purified using a protein precipitation method. Detection was performed on an AB Sciex 5500 mass spectrometer in the positive electrospray ionization mode. The established method was validated according to the bioanalytical guidelines. Conclusion: For the first time, the developed and validated method was successfully applied in the first-in-human study for FP-208 in patients with solid tumors after oral administration (Number: CTR20180683).

100 Deals associated with FP-208

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced cancer	Phase 1	CN	Foreland Pharma Co Ltd	16 Jan 2019
Advanced Malignant Solid Neoplasm	Phase 1	CN	Foreland Pharma Co Ltd	16 Jan 2019

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