2025-521852-45-00招募中2 期
An Open-Label, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PTX-100 Monotherapy in Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma.
Prescient Therapeutics Limited6 个研究点 分布在 2 个国家目标入组 25 人开始时间: 2025年12月8日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
To determine the efficacy of PTX-100
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Phase 2b
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Adult patient ≥18 years of age
- •Has an ECOG PS of 0 to
- •Life expectancy of 3 months or greater
- •Has adequate bone marrow function as defined below: • Absolute neutrophil count (ANC) ≥ 1.0×109/L (without growth factors). • Platelet count ≥ 50×109/L • Hemoglobin ≥ 8.0 g/dL (without erythroid stimulating agents)
- •Has adequate hepatic function as defined below: •Total bilirubin ≤ 1.5 × upper limit of normal (ULN)(Patients with Gilbert’s Syndrome or hepatic involvement may be eligible at the Investigator’s discretion in consultation with the Medical Monitor if < 3 × ULN) and Alanine aminotransferase ≤ 2.5×ULN • Aspartate aminotransferase ≤ 2.5×ULN
- •Has adequate Renal function as defined below: • Creatinine Calculated or estimated creatinine clearance of ≥ 50 mL/min by Cockcroft-Gault
- •Has adequate coagulation function as defined below: • INR < 1.5 ULN • Activated partial thromboplastin time ≤ 1.5 ULN
- •Patient is capable of giving adequate signed informed consent
- •Have a confirmed diagnosis of CTCL with histological confirmation of: a. Mycosis fungoides (MF) OR b. Sezary syndrome (SS) c. Other CTCL subtypes may be permitted after discussion with the medical monitor. NOTE: Histopathology confirmation of CTCL is based on ISCL/EORTC criteria
- •Patients must have greater than or equal to Stage IB disease for MF/SS subtypes. For non MF/non SS subtypes, must have at least T2 disease based on ISCL/EORTC criteria and consideration for inclusion into the study must first be discussed with the medical monitor. (ref: Olsen EA et al. Blood 140 (5); 2022)
- •Has received and failed (or intolerant of) at least 2 prior lines of prior systemic therapy for their disease. Systemic therapies can include any of the following: INF-α, chemotherapy agent such as methotrexate, histone deacetylase inhibitors, antibody drug conjugates, monoclonal antibodies or a prior investigational agent.
- •Has measurable disease defined by at least one of the following, within 28 days prior to start of study treatment: a. Skin lesions evaluable by mSWAT >0 (Refer to Revised International Working Group [Olsen 2022]) OR b. Atypical and/or malignant lymphocytes quantifiable by flow cytometry or morphology in blood based on Olsen 2022 staging criteria OR c. Extracutaneous disease measurable by Lugano Criteria
- •On a stable dose of systemic corticosteroid (≤10 mg prednisone or equivalent) are permitted. Participants on a stable dose of topical corticosteroids are permitted.
- •Washout period- must be 2 weeks (4 weeks for monoclonal antibodies) or 5 -half-lives (whichever is longer) since any prior anti-cancer therapy
- •Must be human T-cell lymphotropic virus type 1 (HTLV1) negative.
排除标准
- •Patients with known central nervous system involvement
- •Has a known psychiatric disorder that would interfere with compliance with the requirements of the study.
- •Is a consumer of illicit or recreational drugs or has a recent history (within the last year) of drug or alcohol abuse or dependence that in the judgment of the Investigator, would interfere with compliance with the requirements of the study
- •Significant cardiovascular disease including any of the following: a. Myocardial infarction within 6 months prior to signing informed consent. b. Uncontrolled angina within 3 months prior to signing informed consent. c. Congestive heart failure; New York Heart Association (NYHA) class III or IV, or a history of congestive heart failure NYHA class III or IV. d. QT interval corrected by the Fridericia correction formula (QTcF) >470 msec at screening. e. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes). f. History of Mobitz II second-degree or third-degree heart block. g. Uncontrolled hypertension as indicated by a resting systolic blood pressure >160 mm Hg or diastolic blood pressure >90 mm Hg at screening.
- •A history of, or concurrent interstitial lung disease or severely impaired lung function.
- •Active viral, bacterial, fungal infection or other serious infection requiring ongoing systemic treatment. Routine antimicrobial prophylaxis is permitted.
- •Medical history of another malignant tumor within the past 3 years. Exceptions are patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ who have undergone curative therapy with no evidence of disease.
- •On an immunomodulatory drug for concomitant or intercurrent conditions or who have received any of these agents within 4 weeks of baseline.
- •Patients with active viral (any etiology) hepatitis are excluded. However, patients with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti-hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV deoxyribose nucleic acid titer < 1000 cps/mL or 200 IU/mL) may be eligible and should be discussed with the Medical Monitor. Patients with a history of hepatitis C virus infection who have completed curative antiviral treatment and have a viral load below the limit of quantification may be eligible and should be discussed with the Medical Monitor.
- •A history or current evidence of any condition, laboratory abnormality or other circumstance that might confound the results of the study or interfere with patient participation for the full duration of the study
- •Prior allogeneic or autologous hematopoietic transplantation
结局指标
主要结局
Objective response rate (ORR)
Objective response rate (ORR)
次要结局
- Further Efficacy: - Skin response as per Modified Severity-Weighted Assessment Tool (mSWAT) - Progression-free survival (PFS) - Duration of response (DOR) - Time to response (TTR) - Complete response rate (CRR) - Overall survival (OS) - Time to next (systemic) treatment (TTNT)
- Safety and Tolerability - Incidence, severity and nature of adverse events (AEs) - Changes from Baseline in vital signs, electrocardiogram (ECG), clinical laboratory values and Eastern Cooperative Oncology Group (ECOG) performance status (PS)
- PK: - PK parameters including: Cmax Tmax, Cmin, AUCtau, AUClast, AUCinf, kel, half-life (t1/2), total body CLss, Vzss, Cmax ratio (Rac-Cmax), and AUC Ratio (Rac-AUC) - Population PK model development (NCM) from data of Phase 2a and Phase 2b data - Population and individual patient PK parameters estimation
研究者
Dr Marissa Lim
Scientific
Prescient Therapeutics Limited
研究点 (6)
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