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

NCT03730142 | Completed Phase 1

• 1 other identifier: JYA0101
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Cancer

Keywords

phosphoinositide-3 kinase (PI3K); mammalian target of rapamycin (mTOR)

Outcome Measures

Primary Outcomes (1)

• Adverse Events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0

  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.

  From first dose to within 30 days after the last dose

Secondary Outcomes (7)

• Maximum plasma concentration (Cmax)

  28 days

• Time to reach plasma Cmax (tmax)

  28 days

• Area under the plasma concentration-time curve (AUC)

  28 days

• Terminal elimination half-life (t½)

  28 days

• Recommended study Phase II dose (RP2D)

  Up to 1 year

Study Arms (1)

WXFL10030390 tablet

EXPERIMENTAL

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)

Drug: WXFL10030390

Interventions

WXFL10030390 DRUG

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

Also known as: WX390

WXFL10030390 tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 and ≤75 years of age
• Histological or cytological confirmed advanced solid tumor or lymphoma, standard regimen failed or no standard regimen available
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Life expectancy of more than 3 months
• At least one measurable lesion according to RECIST 1.1 or Lugano 2014
• Adequate organic function: Absolute neutrophil count (ANC) ≥2.0×109/L，PLT≥100×109/L，Hb≥9g/L hepatic function:TBIL≤1.5×upper limit of normal (ULN)，Alanine aminotransferase (ALT) ≤2.5×ULN，aspartate aminotransferase (AST) ≤2.5×ULN; renal function:Cr≤1.5×ULN and\>50ml/min; coagulation function: APTT≤1.5 ×ULN，PT≤1.5 ×ULN, INR≤1.5 ×ULN; GLU\<7mmol/L and HbA1C\<7%; TG≤1.5×ULN，CHOL≤1.5×ULN
• Subjects who have the fertility should agree to use reliable contraceptive methods during this study and subsequently at least 12 weeks after the last administration; for female subjects, the blood pregnancy test should be negative within 7 days prior to the enrollment
• Signed and dated informed consent

You may not qualify if:

• Anti-cancer therapy within 4 weeks prior to the initiation of investigational treatment
• Surgery within 4 weeks prior to the initiation of study treatment
• Use of strong inducers or inhibitors of CYP3A4 within 1 weeks before the first dose of study treatment. See Appendix 5 for a list of such medications
• Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment
• Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for alopecia)
• Patients with clinical symptomatic brain metastases, spinal compression, meningitis carcinomatosa or other evidence that shows uncontrolled brain or spinal metastases
• Previous treatment with PI3K/mTOR inhibitors
• Patients who once or being suffer Interstitial lung disease
• Evidence of ongoing or active infection
• History of human immunodeficiency virus (HIV) infection
• History of hepatitis B or C infection
• Clinically significant cardiovascular disease, including but not limited to acute coronary syndrome, congestive heart-failure, cerebral stroke within 6 months prior to enrollment, New York Heart Association Class ≥II cardiac functional grading or left ventricular ejection fraction (LVEF) \< 50%
• Inability to take medication orally
• Severe gastrointestinal disease leading to diarrhea
• Diabetics receiving insulin treatment

Sponsors & Collaborators

• Shanghai Jiatan Pharmatech Co., Ltd: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Hereditary Sensory and Autonomic Neuropathies

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Jin Li, Doctor

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: November 5, 2018
• Study Start: October 25, 2018
• Primary Completion: July 25, 2020
• Study Completion: July 25, 2020
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)