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

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

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

Study Overview

• Status: Recruiting
• Conditions: Non-Hodgkin Lymphoma; Advanced Solid Tumor
• Intervention / Treatment: Drug: AXT-1003

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wilson Wang; Phone Number: +86 10 65120010; Email: wilson.wang@axtertx.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: AXT-1003; Dose Escalation: Part A: Level 1 (Starting Dose) Oral AXT-1003 5 mg BID; Level 2 Oral AXT-1003 10mg BID; Level 3 Oral AXT-1003 15mg BID ; Level 4 Oral AXT-1003 20mg BID; Level 5 Oral AXT-1003 25mg BID; Level 6 Oral AXT-1003 30mg BID; Level 7 Oral AXT-1003 35mg BID; Level 8 Oral AXT-1003 40mg BID; Dose Escalation: Part B: Oral AXT-1003 2.5mg QD, 10mg BID; Dose Expansion: 1 or 2 cohorts at the dose levels selected from dose escalation part

Drug: AXT-1003; AXT-1003 capsule is administered orally daily, until disease progression or intolerable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Dose-Limiting Toxicity (DLT) (Dose Escalation)	Dose Escalation only: to characterize the dose limiting toxicities (DLTs) of AXT-1003.	Up to 28 days
Number of Participants with Adverse Events (AEs)	Laboratory test ,ECG, vital signs, physical examination	Baseline up to 30 days after the last dose of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rates (ORR)	ORR is defined as the proportion of subjects with a CR or PR.	Up to 3 years
Duration of response(DOR)	DOR is defined as the time from the initial objective response to progression of disease (PD) or death after the response, whichever occurs first.	Up to 3 years
Time to response (TTR)	Time to response is defined as the time from first dose of study treatment to the first objective tumor response.	Up to 3 years
Disease control rate (DCR)	Disease control rate is defined as the proportion of subjects with a CR, PR, or stable disease(SD).	Up to 3 years
Maximum observed concentration (Cmax) of AXT-1003	Pharmacokinetics of AXT-1003	Up to 15 days
Time of maximum observed concentration (tmax) of AXT-1003	Pharmacokinetics of AXT-1003	Up to 15 days
Minimum observed concentration (Cmin) of AXT-1003	Pharmacokinetics of AXT-1003	Up to 15 days
Terminal elimination half-life (t1/2) of AXT-1003	Pharmacokinetics of AXT-1003	Up to 15 days
Total body clearance (CL/F) of AXT-1003	Pharmacokinetics of AXT-1003	Up to 15 days
Progression free survival (PFS)	Progression-free survival is defined as the time from the first dose of study treatment to the first PD or death for any reason in the absence of documented PD, whichever occurs first.	Up to 3 years
Area under the curve from the time of dosing to the time of the last measurable concentration (AUCtau) of AXT-1003	Pharmacokinetics of AXT-1003	Up to 15 days

Collaborators and Investigators

• Sponsor: Axter Therapeutics (Beijing) Co., Ltd
• Investigators: Study Director: Qian Gao, Axter Therapeutics (Beijing) Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Phase I; Advanced malignancies; EZH2; AXT-1003
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: AXT1003-1102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No