Actively Recruiting
Study of AXT-1003 in Subjects With Advanced Malignant Tumors.
Led by Axter Therapeutics (Beijing) Co., Ltd · Updated on 2026-01-28
78
Participants Needed
5
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I study of AXT-1003 to assess the safety, tolerability, and pharmacokinetics in patients with advanced malignancies.
CONDITIONS
Official Title
Study of AXT-1003 in Subjects With Advanced Malignant Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed/refractory non-Hodgkin lymphoma or locally advanced, unresectable, or metastatic solid tumors after standard therapies
- For dose expansion: relapsed/refractory peripheral T-cell lymphoma
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Measurable lesions per standard criteria (for dose expansion participants)
- Adequate organ and bone marrow function
- Completion of required washout period from prior therapies
- Use of highly effective contraception during study and for 3 months after
- Signed informed consent and agreement to comply with study requirements
You will not qualify if you...
- Diagnosis of precursor lymphoblastic leukemias/lymphomas or chronic lymphocytic leukemia/small lymphocytic lymphoma
- Central nervous system involvement
- Uncontrolled or significant heart disease
- Major surgery within 4 weeks before starting study drug
- Known or suspected allergy to AXT-1003 or its ingredients
- Inability to take oral medication or uncontrolled gastrointestinal conditions affecting drug absorption
- History of other cancers unless successfully treated and disease-free for 5 years
- Unresolved or unstable prior treatment-related toxicities
- Active infections needing treatment
- Hepatitis B or C infection with active virus
- HIV infection or active tuberculosis
- Pregnancy or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
2
Hunan Cancer Hosptial
Changsha, China
Actively Recruiting
3
Fujian Cancer Hospital
Fuzhou, China
Actively Recruiting
4
Sun Yat-Sen University Cancer Center
Guangzhou, China
Actively Recruiting
5
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
W
Wilson Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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