This is an open-label, non-randomized clinical study to evaluate the pharmacokinetic (PK) profiles, safety, tolerability and preliminary efficacy of oral abexinostat monotherapy in patients with non-Hodgkin's lymphoma who have failed standard of care, and thereby to determine the pharmacokinetic (PK) parameters, the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) of the oral monotherapy of abexinostat.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Histologically confirmed diagnosis o f non Hodgkin's lymphoma
* Patients with non-Hodgkin's lymphoma who have either failed standard of care or are intolerant/unapplicable to therapy;
* Subject who has no growth factor supportive therapy, transfusion of blood or blood products within 14 days before the enrollment test
* The patient is capable and willing to accept the follow up according to the protocol and signed or provided the ICF signed by the legal representative
* Contraceptive measures , definition of women of childbearing age and contraceptive requirements
Exclusion Criteria:
* Subjects who have received anti tumor therapy and have not recovered from previous toxicity reactions ( toxicity reactions unrecovered to grade 1 as per NCI CTCAE 5.0
* Subjects who received major surgery (excluding diagnostic biopsy)within 28 days prior to the first dose.
* Subjects who received autologous stem cell transplantation within 3 months or allogeneic stem cell transplantation within 6 months prior to the first dose with active graft versus host response at screening
* Subjects with use of prohibited medication within 7 days or less than 5 half lives prior to the first dose (whichever is shorter), see prohibited medication list
* Participated in other interventional clinical trial within 1 month or 5 half life periods prior to the first dose (whichever is longer), except for non intervention clinical trials
* Evidence suggests that there may be human immunodeficiency virus (HIV) infection , or hepatitis C (HCV) hepatitis virus infection PCR RNA positive);
* Uncontrolled systemic infection or infection requiring intravenous injection of antibiotics
* Lymphoma with central nervous system (CNS) involvement
* Subjects with concurrent other malignant tumors in addition to the studied tumor within 2 years prior to the first dosing , except for the controlled skin basal cell carcinoma , cervical carcinoma in situ, ductal carcinoma in situ , and papillary thyroid carcinoma
* Subject is known to be allergic to the components of abexinostat
* Pregnant and lactating subjects
* Upon the investigator's judgment , the subject has any disease or medical condition that is unstable or may affect safety or study compliance , such as uncontrolled hypertension,uncontrolled diabetes, active bleeding , etc.
Primary outcome measure(s)
Measure AUC at Different Dose Level — Up to 6 month Measure Area under the plasma concentration versus time curve (AUC) levels at different dose level
Measure Cmax at Different Dose Level — Up to 6 month Measure Peak Plasma Concentration (Cmax at different dose level
Determine the maximum tolerated dose — Up to 6 month Determine the maximum tolerated dose based on observed dose-limiting toxicity at different dose levels
Trial sites (4)
Facility
City
Region
Status
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
China
Zhejiang Cancer Hospital
Hangzhou
China
Tianjin Medical University General Hospital
Tianjin
China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
China
More Xynomic Pharmaceuticals, Inc. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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