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

NCT04024696 | Active Not Recruiting Phase 1

• 1 other identifier: XYN-609
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Measure Objective Response Rate

  Up to 12 Month

• Measure Duration of Response

  Up to 12 Month

Study Arms (1)

Dosing Cohorts

EXPERIMENTAL

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

Interventions

Abexinostat DRUG

Abexinostat Tosylate Tablets

Dosing Cohorts

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xynomic Pharmaceuticals, Inc.: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (4)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Zhejiang Cancer Hospital

Hangzhou, 310022, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, 221006, China

Location

Related Publications (1)

• Gui L, Xie Z, Qin Y, Liu P, Yang J, Chen X, Li Z, Tao R, Shi Y. Safety, pharmacokinetics, and efficacy of abexinostat, an novel histone deacetylase inhibitor, in Chinese patients with relapsed/refractory B cell non-Hodgkin lymphoma: a Phase 1 study. BMC Cancer. 2025 May 30;25(1):967. doi: 10.1186/s12885-025-14370-y.

  PMID: 40442628 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

abexinostat

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yuankai Shi, M.D.; Prof

  Cancer Hospital Chinese Academy of Medical Science

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Cohort 1: 40 mg BID Cohort 2: 60 mg BID Cohort 3: 80 mg BID

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 18, 2019
• Study Start: January 8, 2020
• Primary Completion: December 30, 2024
• Study Completion: November 30, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)