A Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese Patients

An Open-Label, Non-Randomized Clinical Study to Evaluate Pharmacokinetic (PK) Profiles, Safety, and Tolerability of Abexinostat Monotherapy in Patients With Non-Hodgkin's Lymphoma Who Have Failed Standard of Care

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non Hodgkin Lymphoma
• Intervention / Treatment: Drug: Abexinostat

Detailed Description

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.

Three (3) dose groups are pre-set to include 40 mg BID, 60 mg BID and 80 mg BID,respectively.The pre-set dose group is subject to change during the study and the actual dosage increment is determined by the Data safety Monitoring Committee (DSMC). A total of 12-16 subjects in the RP2D dose group will be required to accept PK blood sampling for the analysis of PK profiles and parameters. The patients will continue treatment until the occurrence of a DLT event, disease progression, intolerant toxicity, withdrawal of ICF, treatment discontinuation determined by the investigator, lost to follow-up, death, or termination of the study, (whichever occurs first).

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100021
    • Cancer Hospital Chinese Academy of Medical Sciences
  • Hangzhou, China, 310022
    • Zhejiang Cancer Hospital
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Xuzhou, China, 221006
    • The Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dosing Cohorts; Three (3) dose cohorts are pre-set to include 40 mg BID, 60 mg BID and 80 mg BID,respectively.The pre-set dose group is subject to change during the study and the actual dosage increment is determined by the Data safety Monitoring Committee (DSMC).	Drug: Abexinostat; Abexinostat Tosylate Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure AUC at Different Dose Level	Measure Area under the plasma concentration versus time curve (AUC) levels at different dose level	Up to 6 month
Measure Cmax at Different Dose Level	Measure Peak Plasma Concentration (Cmax at different dose level	Up to 6 month
Determine the maximum tolerated dose	Determine the maximum tolerated dose based on observed dose-limiting toxicity at different dose levels	Up to 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure Objective Response Rate	Measure objective response rate in % at the RP2D in patients with non-Hodgkin's lymphoma who have failed standard of care	Up to 12 Month
Measure Duration of Response	Measure duration of response in months at the RP2D in patients with non-Hodgkin's lymphoma who have failed standard of care	Up to 12 Month

Collaborators and Investigators

• Sponsor: Xynomic Pharmaceuticals, Inc.
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Yuankai Shi, M.D.; Prof, Cancer Hospital Chinese Academy of Medical Science

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Actual): December 30, 2024
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Histone Deacetylase Inhibitors; Abexinostat
• Other Study ID Numbers: XYN-609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No