Study Overview
Shanghai GOBROAD Cancer Hospital is currently conducting an open-label, multicenter, Phase I safety study evaluating AXT-1003 capsules in patients with advanced malignancies. The trial has received approval from the National Medical Products Administration and the Ethics Committee of Shanghai GOBROAD Cancer Hospital. Enrollment is open to eligible patients on a voluntary basis.
AXT-1003 is a novel, orally administered, non-SAM-competitive small-molecule inhibitor that selectively targets EZH2, an epigenetic regulator implicated in the growth and survival of several cancer types. By modulating EZH2 activity, AXT-1003 aims to restore normal gene-expression patterns and suppress tumor progression.
Tumor Types Under Study
The trial is enrolling patients with relapsed or refractory non-Hodgkin lymphoma and selected advanced solid tumors, including but not limited to:
- Advanced triple-negative breast cancer (TNBC)
- Advanced lung cancer (LC)
- Advanced urothelial carcinoma (UC)
- Advanced soft tissue sarcoma (STS)
- Metastatic castration-resistant prostate cancer (CRPC)
- Recurrent ovarian cancer
- Other advanced solid tumors as determined by the study protocol
Key Inclusion Criteria
Patients must meet the following main criteria to be considered for enrollment:
- Pathologically confirmed relapsed or refractory non-Hodgkin lymphoma, or an advanced solid tumor among the eligible tumor types listed above
- Age 18 years or older, of any sex
- Adequate organ and bone marrow function, including absolute neutrophil count (ANC) ≥ 1.5 × 10²/L, hemoglobin (Hb) ≥ 9.0 g/dL, and platelets (PLT) ≥ 100 × 10²/L
- Good overall performance status, as assessed by the investigator
Key Exclusion Criteria
Patients with any of the following conditions are generally not eligible:
- Known central nervous system metastases
- Uncontrolled or clinically significant cardiovascular disease, including unstable hypertension (systolic blood pressure > 160 mmHg or diastolic > 100 mmHg) or hypotension (systolic < 90 mmHg or diastolic < 50 mmHg on two consecutive readings) despite medical therapy
- Active infection
- Active hepatitis B infection (HBsAg positive) or hepatitis C infection (HCV antibody positive with detectable HCV RNA)
- Known HIV infection or active tuberculosis
- Inability to swallow oral medication, malabsorption syndrome, or other uncontrolled gastrointestinal conditions (such as nausea, diarrhea, or vomiting) that could affect AXT-1003 absorption
- Pregnancy or breastfeeding
Eligibility Confirmation
Whether a patient meets all inclusion and exclusion criteria will be determined by comprehensive medical evaluation and investigator assessment. The information above is a summary; final eligibility depends on the full screening procedures defined in the study protocol.
How to Express Interest
International patients and caregivers who may be interested in this trial can reach MedTourChina's central coordination team for a preliminary eligibility discussion and referral to the study team at Shanghai GOBROAD Cancer Hospital.
MedTourChina Central Line
📞 Phone / WhatsApp: +86 17742026990
✉ Email: info@healthtourchina.net
🌐 Online: Request a Consultation
Please include the trial name (AXT-1003 Phase I), the tumor type, and a brief treatment history when contacting us. MedTourChina will facilitate communication with the hospital's clinical trial office and help arrange medical-record review, eligibility screening, and visit logistics.
About Shanghai GOBROAD Cancer Hospital
Shanghai GOBROAD Cancer Hospital, part of GOBROAD Medical Group, is a specialized oncology center with an active clinical-trials program spanning hematologic malignancies and solid tumors. The hospital partners with leading academic institutions and biotechnology companies to provide eligible patients access to emerging therapies in a regulated, patient-centered environment.