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Trial Title:
Study of AXT-1003 in Subjects With Advanced Malignant Tumors.
NCT ID:
NCT06484985
Condition:
Non-Hodgkin Lymphoma
Advanced Solid Tumor
Conditions: Official terms:
Lymphoma, Non-Hodgkin
Neoplasms
Conditions: Keywords:
AXT-1003
EZH2
Phase I
Advanced malignancies
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AXT-1003
Description:
AXT-1003 capsule is administered orally daily, until disease progression or intolerable
toxicity.
Arm group label:
AXT-1003
Summary:
This is a Phase I study of AXT-1003 to assess the safety, tolerability, and
pharmacokinetics in patients with advanced malignancies.
Detailed description:
AXT1003-1102 is a multicenter, open-label, Phase I safety study of AXT-1003 in patients
with advanced malignancies. It is designed to observe the safety of AXT-1003 in patients
with advanced malignancies, determine the maximum tolerated dose (MTD) and recommended
Phase 2 dose (RP2D), evaluate the pharmacokinetic profile, and explore the preliminary
antitumor activity.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. For Ia dose escalation part only:
R/R NHL: Locally histopathological diagnosis of relapsed/refractory non-Hodgkin
lymphoma (R/R NHL), who have progressed or been intolerant after the available
standard therapies, or have no access to the standard therapies.
Advanced solid tumors: Locally histopathological diagnosis of locally advanced
unresectable and metastatic solid tumors,The above subjects have progressed or been
intolerant after the available standard therapies, or have no access to the standard
therapies.
For Ib dose expansion part only: Subjects with relapsed/refractory peripheral T-cell
lymphoma (R/R PTCL)
2. Eastern Cooperative Oncology Group (ECOG) performance status scale 0 to 1.
3. Have a life expectancy of at least 3 months.
4. For Ib dose expansion part and not mandatory for Ia dose escalation part: Subjects
with R/R NHL must have measurable lesions as defined by Lugano 2014 criteria.
Subjects with advanced solid tumors must have measurable or evaluable lesions as
defined by RECIST 1.1.
5. Adequate organ and bone marrow functions.
6. The adequate washout period for prior therapy .
7. Subjects must use a highly effective contraception method throughout the study and
for 3 months after discontinuation of the study drug.
8. Signed ICF and willing to comply with all the requirements in the protocol.
Exclusion Criteria:
1. Received treatment with compounds with the same mechanism of action (EZH2 inhibitor,
EZH1/EZH2 inhibitor etc.).
2. Diagnosis of precursor B-cell lymphoblastic leukemia/lymphoma, precursor T-cell
lymphoblastic leukemia/lymphoma, precursor NK cell lymphoblastic leukemia/lymphoma.
Diagnosis of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL).
3. Central nervous system infiltration.
4. Uncontrolled or significant cardiovascular disease.
5. Major surgery within 4 weeks before the first dose of study drug.
6. Known or suspected hypersensitivity to AXT-1003 or any of the excipients.
7. Inability to take oral medication, or malabsorption syndrome or any other
uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that
might impair the bioavailability of AXT-1003.
8. History of other malignancies prior to enrollment; except for subjects with basal
cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ,
or other carcinomas in situ who have undergone possible curative treatment and do
not have disease recurrence within 5 years since starting the treatment.
9. Any prior treatment-related clinically significant toxicities that have not resolved
to Grade ≤ 1 or prior treatment-related toxicities that are clinically unstable and
clinically significant at time of enrollment.
10. Active infection requiring systemic treatment.
11. Infection with hepatitis B virus with positive hepatitis B surface antigen, or
hepatitis C virus with detectable anti-hepatitis C circulating viral RNA.
12. Subjects known to be infected with human immunodeficiency virus and active
tuberculosis.
13. Females who are pregnant or breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Facility:
Name:
Hunan Cancer Hosptial
Address:
City:
Changsha
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Start date:
September 4, 2024
Completion date:
September 2027
Lead sponsor:
Agency:
Axter Therapeutics (Beijing) Co., Ltd
Agency class:
Industry
Source:
Axter Therapeutics (Beijing) Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06484985
