Testing AXT-1003 for advanced malignant tumors

An Open-label, Multicenter, Phase I Safety Study of AXT-1003 in Subjects With Advanced Malignant Tumors

This study is testing a new treatment called AXT-1003 to see if it is safe and effective for people with advanced cancers like non-Hodgkin lymphoma and solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Axter Therapeutics (Beijing) Co., Ltd (Industry-sponsored)
• Locations: 5 sites (Beijing and 4 other locations)
• Trial ID: NCT06484985 on ClinicalTrials.gov

What this trial studies

This Phase I study evaluates the safety, tolerability, and pharmacokinetics of AXT-1003 in patients with advanced malignancies, including non-Hodgkin lymphoma and advanced solid tumors. The study is multicenter and open-label, focusing on determining the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) while also exploring preliminary antitumor activity. Participants will receive AXT-1003 and will be monitored for safety and effectiveness.

Who should consider this trial

Good fit: Ideal candidates include patients with relapsed or refractory non-Hodgkin lymphoma or advanced solid tumors who have progressed after standard therapies or have no access to them.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced malignancies who have limited therapeutic alternatives.

How similar studies have performed: Other studies targeting similar malignancies with novel agents have shown promise, indicating potential for success with this approach.

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. 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).
2. Central nervous system infiltration.
3. Uncontrolled or significant cardiovascular disease.
4. Major surgery within 4 weeks before the first dose of study drug.
5. Known or suspected hypersensitivity to AXT-1003 or any of the excipients.
6. 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.
7. 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.
8. 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.
9. Active infection requiring systemic treatment.
10. Infection with hepatitis B virus with positive hepatitis B surface antigen, or hepatitis C virus with detectable anti-hepatitis C circulating viral RNA.
11. Subjects known to be infected with human immunodeficiency virus and active tuberculosis.
12. Females who are pregnant or breastfeeding.

Where this trial is running

Beijing and 4 other locations

• Beijing Cancer Hospital — Beijing, China (Recruiting)
• Hunan Cancer Hosptial — Changsha, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, China (Recruiting)
• Sun Yat-Sen University Cancer Center — Guangzhou, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Wilson Wang

Conditions Non-Hodgkin Lymphoma; Advanced Solid Tumor; AXT-1003; EZH2; Phase I; Advanced malignancies