Phase
Condition
Non-hodgkin's Lymphoma
White Cell Disorders
Marginal Zone Lymphoma
Treatment
AXT-1003
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For Ia dose escalation part only: R/R NHL: Locally histopathological diagnosis of relapsed/refractory non-Hodgkinlymphoma (R/R NHL), who have progressed or been intolerant after the availablestandard therapies, or have no access to the standard therapies. Advanced solid tumors: Locally histopathological diagnosis of locally advancedunresectable and metastatic solid tumors,The above subjects have progressed or beenintolerant after the available standard therapies, or have no access to the standardtherapies. For Ib dose expansion part only: Subjects with relapsed/refractory peripheral T-celllymphoma (R/R PTCL)
Eastern Cooperative Oncology Group (ECOG) performance status scale 0 to 1.
Have a life expectancy of at least 3 months.
For Ib dose expansion part and not mandatory for Ia dose escalation part: Subjectswith R/R NHL must have measurable lesions as defined by Lugano 2014 criteria.Subjects with advanced solid tumors must have measurable or evaluable lesions asdefined by RECIST 1.1.
Adequate organ and bone marrow functions.
The adequate washout period for prior therapy .
Subjects must use a highly effective contraception method throughout the study andfor 3 months after discontinuation of the study drug.
Signed ICF and willing to comply with all the requirements in the protocol.
Exclusion
Exclusion Criteria:
Received treatment with compounds with the same mechanism of action (EZH2 inhibitor,EZH1/EZH2 inhibitor etc.).
Diagnosis of precursor B-cell lymphoblastic leukemia/lymphoma, precursor T-celllymphoblastic leukemia/lymphoma, precursor NK cell lymphoblastic leukemia/lymphoma.Diagnosis of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL).
Central nervous system infiltration.
Uncontrolled or significant cardiovascular disease.
Major surgery within 4 weeks before the first dose of study drug.
Known or suspected hypersensitivity to AXT-1003 or any of the excipients.
Inability to take oral medication, or malabsorption syndrome or any otheruncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) thatmight impair the bioavailability of AXT-1003.
History of other malignancies prior to enrollment; except for subjects with basalcell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ,or other carcinomas in situ who have undergone possible curative treatment and donot have disease recurrence within 5 years since starting the treatment.
Any prior treatment-related clinically significant toxicities that have not resolvedto Grade ≤ 1 or prior treatment-related toxicities that are clinically unstable andclinically significant at time of enrollment.
Active infection requiring systemic treatment.
Infection with hepatitis B virus with positive hepatitis B surface antigen, orhepatitis C virus with detectable anti-hepatitis C circulating viral RNA.
Subjects known to be infected with human immunodeficiency virus and activetuberculosis.
Females who are pregnant or breastfeeding.
Study Design
Study Description
Connect with a study center
Beijing Cancer Hospital
Beijing,
ChinaActive - Recruiting
Hunan Cancer Hosptial
Changsha,
ChinaSite Not Available
Fujian Cancer Hospital
Fuzhou,
ChinaSite Not Available
Sun Yat-Sen University Cancer Center
Guangzhou,
ChinaSite Not Available
Fudan University Shanghai Cancer Center
Shanghai,
ChinaActive - Recruiting
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