Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera

NCT07232290 | Recruiting Phase 2

• 1 other identifier: FM-PV-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This trial adopts an open, randomized, parallel controlled, multicenter clinical trial design planning to enroll patients with polycythemia vera who are resistant/intolerant to hydroxyurea or interferon。The study divided into two stages: dose exploration stage: three dose groups are tentatively set, with three subjects in each group, totaling nine subjects in each group; Dose extension stage: Based on the safety, efficacy, and pharmacokinetic results of the comprehensive dose exploration stage, 2-3 dose groups are planned to be selected for dose extension trials.

Conditions

Polycythemia Vera (PV)

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects who achieved HCT control

  Achieve HCT\<45% without undergoing venous bloodletting or apheresis treatmen

  At the end of the 28th week

Secondary Outcomes (5)

• The proportion of subjects who achieved complete hematological remission

  week 28 and 52

• The duration of HCT control

  The time elapsed from the date when HCT control was first recorded from the start of Day 29 treatment to the date when HCT increased to >= 45%

• Changes in the total symptom score of MPN-SAF TSS scale

  week 16, 28, 40, and 52

• Proportion of subjects who did not experience thrombosis or bleeding events

  week 28 and 52

• Changes in gene mutation burden relative to baseline

  week 28 and 52

Study Arms (4)

Dose exploration stage group 1

EXPERIMENTAL

Flonoltinib 75mg

Drug: Flonoltinib 75mg

Dose exploration stage group 2

EXPERIMENTAL

Flonoltinib 100mg

Drug: Flonoltinib 100mg

Dose exploration stage group 3

EXPERIMENTAL

Flonoltinib 125mg

Drug: Flonoltinib 125mg

Extended Phase Dose Group

EXPERIMENTAL

Based on the safety, efficacy, and pharmacokinetic results of the comprehensive dose exploration stage，Flonoltinib xxmg，QD

Drug: Extended Phase Dose Group

Interventions

Flonoltinib 75mg DRUG

Flonoltinib Maleate Tablet 75mg, oral administration, once daily, given on an empty stomach for 8 consecutive weeks of treatment.

Dose exploration stage group 1

Flonoltinib 100mg DRUG

Flonoltinib Maleate Tablet 100mg, oral administration, once daily, given on an empty stomach for 8 consecutive weeks of treatment.

Dose exploration stage group 2

Flonoltinib 125mg DRUG

Flonoltinib Maleate Tablet 125mg, oral administration, once daily, given on an empty stomach for 8 consecutive weeks of treatment.

Dose exploration stage group 3

Extended Phase Dose Group DRUG

Based on the safety, efficacy, and pharmacokinetic results of the comprehensive dose exploration stage

Extended Phase Dose Group

Eligibility Criteria

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

You may qualify if:

• Age \>= 18 years old and gender not limited when signing the informed consent form;
• Diagnosed as PV according to WHO standards (2016 edition), and resistant/intolerant to hydroxyurea or interferon treatment (refer to attachments 1 and 2);
• When screening, the peripheral blood primitive cells are 0%;
• Meet any of the following criteria and achieve HCT\<= 45% before randomization/enrollment:
• )At least 2 venous bloodletting and/or apheresis treatments have been performed within 24 weeks prior to screening, with a minimum interval of 4 weeks between each treatment, and at least 1 treatment has occurred within 16 weeks prior to screening; 2)At least one venous bloodletting and/or apheresis treatment has been performed within the 16 weeks and HCT\>45% at the time of screening; 5.When screening, laboratory test indicators meet the following criteria: neutrophil count \>= 1.0 × 10 \^ 9/L, platelet count \>= 100 × 10 \^ 9/L and \<= 1000 × 10 \^ 9/L; ALT and AST\<= 2.5 × ULN; TBIL\<=2.0×ULN; Serum creatinine \<= 1.5 × ULN; 6.ECOG 0-2 points; 7.Can understand and voluntarily sign an informed consent form.

You may not qualify if:

• Individuals with allergies or suspected allergies to the test drug and its excipients;
• In addition to PV, any other myeloproliferative neoplasms (MPN), including post polycythemia vera myelofibrosis (PPV-MF), may also be present;
• Any active infections that require systemic treatment (oral, intravenous, subcutaneous, intramuscular, etc.) during screening;
• Patients with swallowing difficulties, chronic diarrhea, or oral absorption disorders are included in the screening process;
• Patients with basic diseases that are difficult to control in combination with drug treatment during screening, including but not limited to: diabetes, hypertension , peripheral neuropathy ;
• Screening for individuals who have experienced congestive heart failure (NYHA class III or above), unstable angina, myocardial infarction, cerebrovascular accidents with functional impairment, or require treatment for arrhythmia within the past 6 months;
• Individuals with QTcF\>450 ms (male) and QTcF\>470 ms (female) on electrocardiogram during screening;
• Individuals who have experienced active tuberculosis infection within the past year prior to screening, or those whose tuberculosis related test results indicate latent infection during screening;
• Patients who have undergone splenectomy or splenic radiotherapy in the past;
• When screening, any of the following situations exist: a) Hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) is positive, and HBV-DNA detection is positive or above the upper limit of normal value; b) HCV antibody positive and HCV-RNA detection positive; c) Positive for anti Treponema pallidum antibody (TP Ab) and positive for Treponema pallidum non-specific antibody (PRP or TRUST) detection; d) Positive for Human Immunodeficiency Virus Antibody (HIV Ab);
• Individuals with epilepsy or mental illnesses requiring medication during screening (excluding insomnia);
• Individuals who have suffered from other malignant tumors within the past 5 years prior to the first administration (excluding cured carcinoma in situ and basal cell carcinoma of the skin);
• Patients with congenital or acquired bleeding disorders or active thrombotic disorders during screening;
• Combining other serious diseases during screening may affect patient safety or compliance, according to researchers;
• Within 2 weeks prior to trial administration or within 5 half lives (whichever is longer), any therapeutic PV drugs have been used, including hydroxyurea, recombinant interferon - α (long-acting recombinant interferon - α treatment needs to be discontinued for 4 weeks), JAK inhibitors (such as Ruxolitinib), 32P (needs to be discontinued for 8 weeks), Busulfan, etc;

Sponsors & Collaborators

• Chengdu Zenitar Biomedical Technology Co., Ltd: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Polycythemia Vera

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders

Study Officials

• Lei Zhang, Doctor

  Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)

  PRINCIPAL INVESTIGATOR

• Ting Niu, Doctor

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Wei Yang, Doctor

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fangmei Wang

CONTACT

+8613808086495; fangmei.wang@zenitar.cn

Liangkun Sun

CONTACT

+8615885742617; liangkunsun@zenitar.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: November 18, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)