FCN-338 in Combination With Azacitidine or Chemotherapy in Myeloid Neoplasms

NCT06858618 | Active Not Recruiting Phase 2

• 1 other identifier: FCN-338-II201
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2, open-label, multicenter study to safety \& tolerability, antitumor activity, and pharmacokinetics of FCN-338 in Combination with szacitidine (AZA) or chemotherapy(erythromycin, cytarabine(Ara-C)) in Patients with myeloid neoplasms

Conditions

Safety; Antitumor Activity; PK Profile

Keywords

BCL-2 inhibitor; Acute Myeloid Leukemia; safety; antitumor activity; PK profile

Outcome Measures

Primary Outcomes (3)

• Incidence of DLT

  Incidence of DLT in DLT observation period

  At the end of Cycle 1 (each cycle is 28 days)

• Title: composite CR rate (CRc)

  The proportion of CR, CRi and MLFS patients in the efficacy analysis set (EAS)

  From the first dose to the end of maintenance phase, assessed up to 30 months

• Minimal residual disease (MRD) negative rate

  The proportion of AML patients with CR/CRi/MLFS who were negative for MRD.

  From the first dose to the end of maintenance phase, assessed up to 30 months

Secondary Outcomes (21)

• Transfusion Independence

  From the first dose to the end of maintenance phase, assessed up to 30 months

• Time to remission

  From the first dose to the first observation of CR/CRi/MLFS, assessed up to 2 months

• Event-free survival

  From the first dose to induction failure or relapse or death from any cause (whichever occours first), assessed up to 54 months

• Duration of remission

  From the first observation of CR/CRi/MLFS to tumor progression or death from any cause(whichever occours first), assessed up to 54 months

• Overall survival

  From the first dose to 30 days after the last dose or the initiation of new antitumor therapy (whichever occours first), assessed up to 30 months

Study Arms (2)

relapse/refractory (R/R) AML

EXPERIMENTAL

Combination Product: FCN-338 + Azacitidine

1L fit AML

EXPERIMENTAL

Combination Product: FCN-338 + erythromycin+ Ara-C

Interventions

FCN-338 + Azacitidine COMBINATION_PRODUCT

FCN-338 (400 or 600 mg, PO, QD, D1-28) combined with azacitidine (75mg/m², SC, QD, D1-7), 28 days/cycle

relapse/refractory (R/R) AML

FCN-338 + erythromycin+ Ara-C COMBINATION_PRODUCT

Induction phase: FCN-338(600 mg, QD, D1-14) , erythromycin (60 mg/m², IV, QD , D1-3) and Ara-C (100 mg/m², IV, QD, D1-7) for 1 to 2 cycles. Consolidation phase: FCN-338(600 mg, QD, D1-14) ,Ara-C (1 to 3 g/m²/12h, 6 doses) for 3 to 4 cycles Maintenance phase:FCN-338(600 mg, QD, D1-14) , azacitidine (50 mg/m², SC, QD, D1-5) for the first 12 cycles and FCN-338 (600 mg, QD, D1-14) alone for the rest 12 cycles

1L fit AML

Eligibility Criteria

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

Inclusive Criteria 1. Age ≥18 years. 2. Cohort A: Patients diagnosed with R/RAML (≥5% blasts in the bone marrow) according to the WHO 2016 criteria \[excluding acute promyelocytic leukemia (APL) and BCR-ABL positive AML\], meeting any of the following definitions: 1\) Relapsed AML: Reappearance of leukemic cells in peripheral blood or ≥5% blasts in bone marrow after complete remission (CR, CRi) (excluding other causes such as bone marrow regeneration after consolidation treatment) or infiltration of leukemic cells outside the marrow; 2) Refractory AML: Ineffective after two cycles of standard treatment; Relapsed within 12 months after CR followed by consolidation treatment; Relapsed after 12 months but ineffective with standard chemotherapy; Relapsed two or more times; With persistent extramedullary leukemia. 3\. Cohort B: Patients diagnosed with 1L fit AML according to the WHO 2016 criteria \[excluding acute promyelocytic leukemia (APL) and BCR-ABL positive AML\]. 4\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 5. Expected survival time ≥ 3 months. 6. Adequate bone marrow and organ function. Exclusive Criteria 1. Patients with diagnosis of APL or BCR-ABL-positive AML patients or a history of prior myeloproliferative disease (MPN). 2. With known leukemic infiltration of the central nervous system. 3. Have received allogeneic hematopoietic stem cell transplantation or overt immune cell therapy, or autologous hematopoietic stem cell transplantation within 1 year. 4. Have active fungal, bacterial and/or viral infections including, but not limited to, active Human Immunodeficiency Virus (HIV), viral hepatitis B or C.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.: lead
• Beijing Fosun Pharmaceutical Technology Development Co., Ltd.: collaborator

Study Sites (1)

Union hospital tongjimedical college huzhong university of science and technology

Wuhan, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: March 5, 2025
• Study Start: August 16, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)