Study of AXT-1003 in Subjects with Advanced Malignant Tumors.

Last updated: March 21, 2025
Sponsor: Axter Therapeutics (Beijing) Co., Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Non-hodgkin's Lymphoma

White Cell Disorders

Marginal Zone Lymphoma

Treatment

AXT-1003

Clinical Study ID

NCT06484985
AXT1003-1102
  • Ages > 18
  • All Genders

Study Summary

This is a Phase I study of AXT-1003 to assess the safety, tolerability, and pharmacokinetics in patients with advanced malignancies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. For Ia dose escalation part only: R/R NHL: Locally histopathological diagnosis of relapsed/refractory non-Hodgkinlymphoma (R/R NHL), who have progressed or been intolerant after the availablestandard therapies, or have no access to the standard therapies. Advanced solid tumors: Locally histopathological diagnosis of locally advancedunresectable and metastatic solid tumors,The above subjects have progressed or beenintolerant after the available standard therapies, or have no access to the standardtherapies. For Ib dose expansion part only: Subjects with relapsed/refractory peripheral T-celllymphoma (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: Subjectswith R/R NHL must have measurable lesions as defined by Lugano 2014 criteria.Subjects with advanced solid tumors must have measurable or evaluable lesions asdefined 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 andfor 3 months after discontinuation of the study drug.

  8. Signed ICF and willing to comply with all the requirements in the protocol.

Exclusion

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-celllymphoblastic 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 otheruncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) thatmight impair the bioavailability of AXT-1003.

  8. History of other malignancies prior to enrollment; except for subjects with basalcell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ,or other carcinomas in situ who have undergone possible curative treatment and donot have disease recurrence within 5 years since starting the treatment.

  9. Any prior treatment-related clinically significant toxicities that have not resolvedto Grade ≤ 1 or prior treatment-related toxicities that are clinically unstable andclinically significant at time of enrollment.

  10. Active infection requiring systemic treatment.

  11. Infection with hepatitis B virus with positive hepatitis B surface antigen, orhepatitis C virus with detectable anti-hepatitis C circulating viral RNA.

  12. Subjects known to be infected with human immunodeficiency virus and activetuberculosis.

  13. Females who are pregnant or breastfeeding.

Study Design

Total Participants: 78
Treatment Group(s): 1
Primary Treatment: AXT-1003
Phase: 1
Study Start date:
September 04, 2024
Estimated Completion Date:
September 30, 2027

Study 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.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing,
    China

    Active - Recruiting

  • Hunan Cancer Hosptial

    Changsha,
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou,
    China

    Site Not Available

  • Sun Yat-Sen University Cancer Center

    Guangzhou,
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai,
    China

    Active - Recruiting

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