BridgeMD
New treatment option for Non-Hodgkin Lymphoma
Official title Study of AXT-1003 in Subjects With Advanced Malignant Tumors.
ClinicalTrials.gov ID: NCT06484985
What this study is testing
What is AXT-1003?
AXT-1003 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase I study of AXT-1003 to assess the safety, tolerability, and pharmacokinetics in patients with advanced malignancies.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For Ia dose escalation part only: R/R NHL: Locally histopathological diagnosis of relapsed/refractory non-Hodgkin lymphoma (R/R NHL), who have...
- 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: people with R/R NHL must have measurable lesions as defined by Lugano 2014...
- Adequate organ and bone marrow functions.
You likely can't join if
- Diagnosis of precursor B-cell lymphoblastic leukemia/lymphoma, precursor T-cell lymphoblastic leukemia/lymphoma, precursor NK cell lymphoblastic...
- 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 other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or...
See the full eligibility criteria
- 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...
- 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: people with R/R NHL must have measurable lesions as defined by Lugano 2014 criteria. people with advanced solid tumors must have measurable or...
- Adequate organ and bone marrow functions.
- The adequate washout period for prior therapy .
- people must use a highly effective contraception method throughout the study and for 3 months after discontinuation of the study drug.
- Signed ICF and willing to comply with all the requirements in the protocol.
- 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...
- 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 other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of AXT-1003.
- History of other malignancies prior to enrollment; except for people with basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or other carcinomas in situ who have undergone...
- 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.
- Active infection requiring systemic treatment.
- Infection with hepatitis B virus with positive hepatitis B surface antigen, or hepatitis C virus with detectable anti-hepatitis C circulating viral RNA.
- people known to be infected with human immunodeficiency virus and active tuberculosis.
- Females who are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changsha, China
- Fuzhou, China
- Guangzhou, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Changsha, China; Fuzhou, China; Guangzhou, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.