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MTOR Inhibitors

WXFL10030390 continuous oral dosing (0.1 mg once a day)

WXFL10030390 continuous oral dosing (0.2 mg once a day)

WXFL10030390 continuous oral dosing (0.4 mg once a day)

WXFL10030390 continuous oral dosing (0.7 mg once a day)

WXFL10030390 continuous oral dosing (1.1 mg once a day)

WXFL10030390 continuous oral dosing (1.4 mg once a day)

WXFL10030390 continuous oral dosing (1.7 mg once a day)

WXFL10030390 is a tablet in the form of 0.1mg and 0.5mg, oral, once a day.

WXFL10030390

Jin Li, Doctor

WXFL10030390 (WX390) is a novel oral small molecular that inhibits phosphoinositide-3 kinase (PI3K) and mammalian target of rapamycin (mTOR) and has demonstrated potent inhibitory effects on multiple human tumor xenografts. The first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of WX390 at single dose and multiple doses.

This study will be an open-lable, phase Ⅰ study and will evaluate the safety and pharmacokinetics of WX390 after a single administration followed by a 28-day continuous course of therapy; evaluate the safety and preliminary efficacy in an open-lable administration of WX390 at the MTD.

A Study of WXFL10030390 in Patients With Advanced Solid Tumors or Lymphoma

A Phase Ⅰ Study of PI3K/mTOR Dual Inhibitor WXFL10030390 to Evaluate the Safety, Tolerability and Pharmacokinetics in Patients With Advanced Solid Tumors or Lymphoma

The safety and tolerability of WXFL10030390 will be evaluated based on adverse events data. Other safety parameters include physical examination, clinical laboratory tests including coagulation function, renal function, hepatic function, blood glucose and blood lipid.

Cmax will be determined for an oral administration of WXFL10030390 tablets.

tmax will be determined for an oral administration of WXFL10030390 tablets.

AUC will be determined for an oral administration of WXFL10030390 tablets.

t½ will be determined for an oral administration of WXFL10030390 tablets.

The recommended phase 2 dose (RP2D) of WXFL10030390 will be determined based on pharmacokinetics, safety and tolerability, as well as preliminary efficacy.

The sum of complete responses (CR) + partial responses (PR) + stable disease (SD) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) or Lugano 2014 criteria

Defined as complete response \[CR\] + partial response \[PR\]) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) or Lugano 2014 criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of WXFL10030390 in Patients With Advanced Solid Tumors or Lymphoma	NCT03730142	Advanced Cancer	WXFL10030390	18 Years - 75 Years	Shanghai Jiatan Pharmatech Co., Ltd
A Study of WXFL10030390 in Patients With Advanced Solid Tumors or Lymphoma	NCT03730142	Advanced Cancer	WXFL10030390	18 Years - 75 Years	Shanghai Jiatan Pharmatech Co., Ltd

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