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SafetyPhase 2NCT06858618

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

A Phase 2 study testing FCN-338 + Azacitidine and FCN-338 + erythromycin+ Ara-C in people with Safety and Antitumor Activity, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Safety, Antitumor Activity, PK Profile
What is being tested?
FCN-338 + Azacitidine and FCN-338 + erythromycin+ Ara-C
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteChina
Study dates
16 Aug 2023to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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:
  3. 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.
  4. Cohort B: Patients diagnosed with 1L fit AML according to the WHO 2016 criteria [excluding acute promyelocytic leukemia (APL) and BCR-ABL positive AML].
  5. 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
  6. Patients with diagnosis of APL or BCR-ABL-positive AML patients or a history of prior myeloproliferative disease (MPN).
  7. With known leukemic infiltration of the central nervous system.
  8. Have received allogeneic hematopoietic stem cell transplantation or overt immune cell therapy, or autologous hematopoietic stem cell transplantation within 1 year.
  9. Have active fungal, bacterial and/or viral infections including, but not limited to, active Human Immunodeficiency Virus (HIV), viral hepatitis B or C.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Union hospital tongjimedical college huzhong university of science and technology

    Wuhan

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate the Safety & Tolerability, Antitumor Activity, and Pharmacokinetics of FCN-338 in Combination With Azacitidine or Chemotherapy in Patients With Myeloid Neoplasms

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

Read the detailed description

Primary Objectives:1.To assess the safety and tolerability of FCN-338 in combination with AZA or chemotherapy in patients with myeloid neoplasms. 2. To explore the antitumor activity of FCN-338 combination therapy in patients with myeloid neoplasms.

Secondary Objectives: 1. To assess the pharmacokinetic profile of the FCN-338 combination therapy in patients with myeloid neoplasms.2. To assess the transfusion independence rate in patients with myeloid neoplasms.

There were 2 cohorts based on different combination therapies and different indications.

Cohort A is FCN-338 combined with AZA (75mg/m², SC, QD, D1-7) for the treatment in relapsed/refractory (R/R) acute myeloid leukemia (AML) patients.

Cohort B is FCN-338 combined with intensive chemotherapy for first line (1L) fit AML patients. During the induction phase, patients will be treated with erythromycin (60 mg/m², IV, QD , D1-3) and Ara-C (100 mg/m², IV, QD, D1-7). Patients achieving partial remission (PR) will repeat induction phase once, and patients who do not reach PR after first cycle of induction phase and those who do not achieve complete remission (CR)/Complete remission with incomplete hematological recovery (CRi)/morphologic leukemia-free state (MLFS) after two cycles of induction phase will receive other new antitumor treatments. Patients who achieve CR/CRi/MLFS will undergo consolidation phase with medium- to high-dose Ara-C (1 to 3 g/m²/12h, 6 doses) for 3 to 4 cycles, with the exact dose and number of cycles determined by investigator. Patients with intermediate- to high-risk according to the 2017 European Leukemia Net (ELN) stratification will undergo a total of 24 cycles of maintenance phase after completion of consolidation phase. Maintenance phase will consist of 24 cycles, FCN-338 in combination with AZA (50 mg/m², d1-5) for the first 12 cycles and FCN-338 alone for the rest 12 cycles. FCN-338 will be administered once daily (QD), D1-14 per cycle during induction phase, consolidation phase and maintenance phase.

Being tested
FCN-338 + Azacitidine, FCN-338 + erythromycin+ Ara-C
Keywords
BCL-2 inhibitor, Acute Myeloid Leukemia, safety, antitumor activity, PK profile
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FCN-338 + AzacitidineCombination product

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

  • FCN-338 + erythromycin+ Ara-CCombination 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

Study groups in NCT06858618
Study groupRoleWhat they receive
relapse/refractory (R/R) AMLExperimentalNot described
Receives: Combination Product: FCN-338 + Azacitidine
1L fit AMLExperimentalNot described
Receives: Combination Product: FCN-338 + erythromycin+ Ara-C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of DLT

    Incidence of DLT in DLT observation period

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

  2. Title: composite CR rate (CRc)

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

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

  3. Minimal residual disease (MRD) negative rate

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

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

Secondary outcomes (21)

  1. Transfusion Independence

    The proportion of independence on red blood cell (RBC) and platelet transfusions among those patients who were dependent on RBC and platelet transfusions at baseline.

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

  2. Time to remission

    Defined as the time from the first dose to the first observation of CR/CRi/MLFS

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

  3. Event-free survival

    Defined as the time from the first dose to induction failure or relapse or death from any cause (whichever occours first).

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

  4. Duration of remission

    Defined as the time from the first observation of CR/CRi/MLFS to tumor progression or death from any cause(whichever occours first).

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

  5. Overall survival

    Defined as the time from the first dose to death from any cause.

    Measured: 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

  6. Incidence of treatment-emergent adverse events(TEAEs) and treatment-related adverse events (TRAEs) [Safety and Tolerability]

    Safety will be evaluated by summarizing DLT, AE, changes in laboratory findings, and changes in vital signs. Adverse events will be summarized for the DLT observation period and the entire treatment period based on the DLT analysis set and the safety analysis set, respectively, and drug-related AEs, SAEs, AEs of toxicity grade ≥3, and AEs leading to discontinuation will be counted. The occurrence of DLT will be assessed specifically for the DLT analysis set.

    Measured: From the first dose to 30 days after the last dose or the initiation of new antitumor therapy (whichever occours first).

  7. Cmax of FCN-338

    Pharmacokinetics of FCN-338 by assesment of the maximum plasma concentration

    Measured: Up to 24 hours postdose

  8. AUC0-t of FCN-338

    Pharmacokinetics of FCN-338 by assesment of the Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration

    Measured: Up to 24 hours postdose

  9. AUC0-24 of FCN-338

    Pharmacokinetics of FCN-338 by assesment of the Area Under The Plasma Concentration Time Curve From Time 0 To The 24 hours postdose

    Measured: Up to 24 hours postdose

  10. AUC0-∞ of FCN-338

    Pharmacokinetics of FCN-338 by assesment of The Plasma Concentration Time Curve From Time 0 To Infinity

    Measured: Up to 24 hours postdose

  11. Tmax of FCN-338

    Pharmacokinetics of FCN-338 by assesment of Time To Maximum Observed Plasma Concentration

    Measured: Up to 24 hours postdose

  12. t1/2 of FCN-338

    Pharmacokinetics of FCN-338 by assesment of Terminal Half-life

    Measured: Up to 24 hours postdose

  13. CL/F of FCN-338

    Pharmacokinetics of FCN-338 by assesment of Apparent Clearance Of Drug From Plasma After Oral Administration

    Measured: Up to 24 hours postdose

  14. Vd/F of FCN-338

    Pharmacokinetics of FCN-338 by assesment of Apparent Volume Of Distribution

    Measured: Up to 24 hours postdose

  15. Css_max of FCN-338

    Pharmacokinetics of FCN-338 by assesment of Maximum Observed Plasma Concentration At Steady State

    Measured: Up to 24 hours postdose

  16. Css_av of FCN-338

    Pharmacokinetics of FCN-338 by assesment of the Average concentration At Steady State

    Measured: Up to 24 hours postdose

  17. AUCss of FCN-338

    Pharmacokinetics of FCN-338 by assesment of the Area Under The Plasma Concentration Time Curve within dosing interval At Steady State

    Measured: Up to 24 hours postdose

  18. DF of FCN-338

    Pharmacokinetics of FCN-338 by assesment of fluctuation

    Measured: Up to 24 hours postdose

  19. MRT

    Pharmacokinetics of FCN-338 by assesment of Mean residence time

    Measured: Up to 24 hours postdose

  20. Kel of FCN-338

    Pharmacokinetics of FCN-338 by assesment of the Terminal rate constant.

    Measured: Up to 24 hours postdose

  21. Css_min of FCN-338

    Pharmacokinetics of FCN-338 by assesment of Trough Concentration At Steady State

    Measured: Up to 24 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2025
  2. Study start16 Aug 2023
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06858618
Sponsor's protocol ID
FCN-338-II201
Status last verified
Jan 2025
First submitted
4 Feb 2025
Last updated
5 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FCN-338 + Azacitidine and FCN-338 + erythromycin+ Ara-C in people with Safety and Antitumor Activity, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of DLT (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06858618.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.

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