A Phase 1/2 Study of ESG206 in Patients With Primary Immune Thrombocytopenia

NCT06853444 | Recruiting Phase 1 DMC

• 1 other identifier: ESG206-ITP-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, open-label Phase1/2 study aimed at evaluating the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamics (PD), immunogenicity, and preliminary efficacy of ESG206. The study will be conducted in patients with primary immune thrombocytopenia.

Conditions

Immune Thrombocytopenia (ITP)

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events

  Treatment-emergent adverse events (TEAEs) were defined as: Any adverse event (AE) that happens after treatment initiation, or AE that was present at time of treatment initiation but worsened after treatment initiation, or AE that was present and resolved prior to treatment and reappeared after treatment initiation after the start of study drug through 28 days after the last dose of study drug or the last post-treatment follow-up. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events.

  Up to 24 weeks.

• Confirmed response rate

  Confirmed response is defined as a platelet count of equal or above 50 G/L at two (or more) consecutive assessments at least 7 days apart, in the absence of: Rescue treatment for ≥4 weeks prior to the assessment of the platelet count, and New immune thrombocytopenia (ITP) treatment before reaching a confirmed response.

  Between Week 1 Day 1 and Week 25 Day 1

Secondary Outcomes (16)

• AUC0-inf

  up to Week 25

• Cmax

  up to Week 25

• Tmax

  up to Week 25

• T1/2

  up to Week 25

• Response rate at each timepoint

  Between Week 1 Day 1 and Week 25 Day 1

Study Arms (4)

ESG206 dose level 1

EXPERIMENTAL

ESG206 will be administered intravenously at dose level 1.

Drug: ESG206

ESG206 dose level 2

EXPERIMENTAL

ESG206 will be administered intravenously at dose level 2.

Drug: ESG206

ESG206 dose level 3

EXPERIMENTAL

ESG206 will be administered intravenously at dose level 3.

Drug: ESG206

ESG206 dose level 4

EXPERIMENTAL

ESG206 will be administered intravenously at dose level 4.

Drug: ESG206

Interventions

ESG206 DRUG

Administered via intravenous (IV) infusion

Also known as: ESG206-2

ESG206 dose level 1

Eligibility Criteria

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

You may qualify if:

• \. Willing and able to provide written informed consent for this trial.
• \. Male or female, age ≥ 18 years on the day of signing the informed consent form.
• \. Diagnosed with primary immune thrombocytopenia (ITP), and having received treatment of corticosteroids ± intravenous immunoglobulin (IVIG) in the past.
• \. At the time of the last ITP treatment, loss of response, insufficient response, no response or intolerance occurred.
• \. At screening, Platelet Count revealed \< 30 \* 10\^9/L twice (with an interval of at least 24 hours between the two tests).
• \. Subjects must have adequate organ function.
• \. The World Health Organization (WHO) bleeding scale is 0-1.
• \. Fertile men and women of reproductive age must agree to use effective contraception from the time they sign the informed consent until 180 days after the last dose of the trial drug. Women of reproductive age include premenopausal women and women within 2 years after menopause. Women who are fertile must have a pregnancy test within 7 days before the trial drug is first given and the result should be negative.

You may not qualify if:

• \. Diagnosed with secondary immune thrombocytopenia, or there is evidence that the patient has a secondary cause of immune thrombocytopenia, or the patient has multiple immune cytopenias.
• \. Previously received B-cell depletion therapy (e.g., rituximab, Ianalumab, etc.).
• \. Received platelet transfusion or whole blood transfusion, plasma exchange, or any other rescue treatment within 14 days before the first administration of the trial drug.
• \. Participated in other investigational drug clinical studies within 4 weeks before the first administration of the investigational drug or within 5 half-lives of the investigational drug received (whichever is longer).
• \. Underwent splenectomy within 12 weeks before the first administration of the investigational drug.
• \. Received traditional Chinese medicine treatment with definite platelet-raising effects within 1 week before the first administration of the trial drug.
• \. Underwent major surgery within 4 weeks before the first administration of the investigational drug or needs to undergo major elective surgery during the study period.
• \. Patients with current or previous life-threatening bleeding related to thrombocytopenia.
• \. Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant therapy (e.g., warfarin, clopidogrel, or new oral anticoagulants), except for low-dose acetylsalicylate (≤150 mg/day).
• \. Patients with deep vein thrombosis or arterial thrombosis within 6 months before enrollment, and/or with risk factors for hereditary thrombophilia.
• \. Patients with a history of severe cardiovascular and pulmonary diseases.
• \. Patients with uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
• \. Patients with human immunodeficiency virus (HIV) infection, or active hepatitis B or C, or liver cirrhosis.
• \. Patients who received live or attenuated live vaccines within 4 weeks before the first administration of the investigational drug.
• \. Patients with a history of or current malignant tumors, except for cured non-melanoma skin cancer, carcinoma in situ (e.g., cervical cancer, breast cancer, bladder cancer, prostate cancer), and cancers that have been in complete remission for at least 3 years without evidence of recurrence.

Sponsors & Collaborators

• Shanghai Escugen Biotechnology Co., Ltd: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Ming Hou, PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyan Xing, PhD

CONTACT

86 21 5855 6098; [email protected]

Ming Hou, PhD

CONTACT

86 531 82169867

Study Design

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

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)