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

NCT06484985 | Recruiting Phase 1

• 1 other identifier: AXT1003-1102
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Non-Hodgkin Lymphoma; Advanced Solid Tumor

Keywords

AXT-1003; EZH2; Phase I; Advanced malignancies

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Overall response rates (ORR)

  Up to 3 years

• Duration of response(DOR)

  Up to 3 years

• Progression free survival (PFS)

  Up to 3 years

• Time to response (TTR)

  Up to 3 years

• Disease control rate (DCR)

  Up to 3 years

Study Arms (1)

AXT-1003

EXPERIMENTAL

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

Interventions

AXT-1003 DRUG

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

AXT-1003

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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: 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.
• Adequate organ and bone marrow functions.
• The adequate washout period for prior therapy .
• Subjects 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.

You may not qualify if:

• 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).
• 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 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.
• 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.
• Subjects known to be infected with human immunodeficiency virus and active tuberculosis.
• Females who are pregnant or breastfeeding.

Sponsors & Collaborators

• Axter Therapeutics (Beijing) Co., Ltd: lead

Study Sites (5)

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

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Qian Gao

  Axter Therapeutics (Beijing) Co., Ltd

  STUDY DIRECTOR

Central Study Contacts

Wilson Wang

CONTACT

+86 10 65120010; wilson.wang@axtertx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: September 4, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)