NCT05426369进行中（未招募）1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Preliminary Efficacy and Pharmacokinetics of SCB-219M in the Patients With Chemotherapy-induced Thrombocytopenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Dose escalation: Occurrence of DLT.
研究概览
简要总结
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Preliminary Efficacy and Pharmacokinetics of SCB-219M in the patients with chemotherapy-induced thrombocytopenia (CIT)
详细描述
The purpose of this trial is to evaluate the safety, tolerability, immunogenicity, and PK characteristics of single and multiple subcutaneous injections of SCB-219M for CIT, explore the MTD and BED, and preliminarily observe and evaluate efficacy. The trial is divided into a dose escalation phase (Ia) and an expansion phase (Ib).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years (inclusive), voluntary participation with signed informed consent and commitment to protocol-defined visits.
- •Body Weight: ≥40 kg.
- •Diagnosis: Histopathologically/cytopathologically confirmed malignant solid tumors or lymphoma.
- •Phase Ia: Platelet (PLT) & Treatment Status:
- •PLT <75×10⁹/L during prior chemotherapy cycle;
- •Receiving mono/combination chemotherapy (may include targeted/immunotherapy). 5.Phase Ib: Stratified Requirements:
- •Group A (1st-line CIT prophylaxis/therapy):
- •PLT <50×10⁹/L, or
- •PLT 50-75×10⁹/L. • Group B (2nd-line CIT therapy/refractory cases): Second-line CIT treatment for refractory or treated CIT patients who failed first-line therapy (rhTPO/IL-11) with platelet count <50×10⁹/L 6.Refractory/Treated CIT Definition:
- •Platelet count remains <50×10⁹/L or increases by <20×10⁹/L within 14 days after completing first-line CIT therapy (e.g., rhTPO or rhIL-11), with baseline PLT <50×10⁹/L at enrollment.
- •7.Toxicity Resolution: Prior anti-tumor toxicity ≤ Grade 2 (CTCAE v5.0) at enrollment (alopecia/vitiligo/subjective symptoms excluded).
- •8.ECOG PS: 0-
- •9.Life Expectancy: ≥3 months (investigator-assessed). 10.Baseline Laboratory (Pre-dose):
- •a) Creatinine ≤1.5×ULN; CrCl >40 mL/min;
- •b) PT/APTT/INR 80-120% of normal range;
- •c) ANC ≥1.5×10⁹/L;
- •d) Hemoglobin ≥70 g/L;
- •e) Albumin ≥25 g/L. 11.Liver Function:
- •a) ALT/AST ≤3×ULN (≤5×ULN if liver metastasis);
- •b) Total bilirubin ≤2.0×ULN (Gilbert's syndrome/asymptomatic cholelithiasis exempted).
- •12.Contraception:
- •Fertile subjects must use ≥1 method:
- •o Absolute abstinence;
- •Double-barrier (condom + spermicidal diaphragm);
- •IUD/hormonal contraceptives (oral/implant/patch/injection);
- •Hysterectomy/bilateral salpingectomy/tubal ligation (females or partners);
- •Vasectomy/azoospermia (males or partners).
- •Females: Negative serum β-HCG within 28 days;
- •Males: No sperm donation from first dose to 180 days post-last dose.
排除标准
- •Pregnancy/Lactation: Pregnant or breastfeeding females.
- •Hypersensitivity: Known allergy to protein-based drugs (e.g., recombinant proteins, mAbs) or excipients of the investigational product.
- •Active Infection: Acute infection requiring IV antibiotics without clinical control.
- •Prior Thrombopoietic Agents:
- •Group A: Use within specified windows pre-SCB-219M:
- •o Trilaciclib: ≤3 weeks
- •o Romiplostim: ≤2 weeks
- •o TPO-RAs (e.g., eltrombopag), rhTPO, IL-11, or platelet transfusion: ≤10 days
- •Group B: Use within:
- •o Romiplostim/rhTPO/IL-11: ≤7 days
- •o TPO-RAs/platelet transfusion: ≤3 days
- •Anticoagulant Use: Anticoagulants/antiplatelet drugs ≤5 half-lives pre-dose or needed during study (aspirin washout ≥7 days).
- •Non-Chemotherapy Thrombocytopenia (within 6 months/unresolved):
- •Clinically significant non-chemotherapy-induced thrombocytopenia (e.g., EDTA-dependent pseudothrombocytopenia) 2) Hematologic malignancies (excluding lymphoma; e.g., leukemia) 3) Multiple myeloma 7.Bleeding Events (within 2 weeks pre-screening):
- •Group A: ≥Grade 2 (WHO Bleeding Scale)
- •Group B: ≥Grade 3 (WHO Bleeding Scale) 8.Non-CIT Thrombocytopenia Etiologies: 1) Primary immune thrombocytopenia (pITP) 2) Bone marrow failure (e.g., aplastic anemia, Fanconi anemia) 3) Myeloproliferative disorders/MDS 4) Hypersplenism secondary to hematologic/autoimmune diseases 9.Splenectomy/Splenic Effects: Splenic metastasis affecting hematopoiesis; splenectomy/splenic artery embolization ≤12 weeks pre-enrollment.
- •10.Uncontrolled Cardiovascular Disease:
- •NYHA Class III/IV heart failure
- •Pro-thrombotic conditions (e.g., atrial fibrillation, unstable angina)
- •QTc >470 ms (>480 ms with bundle branch block)
- •Myocardial infarction ≤6 months (Note: Pacemaker/ICD users with normal function eligible) 11.Thrombotic/Coagulation Disorders:
- •Coagulopathies
- •Arterial/venous thrombosis ≤3 months (excluding PICC-related thrombosis)
- •Transient ischemic attack ≤3 months 12.Major Procedures/Radiotherapy: Major surgery/radiotherapy ≤4 weeks pre-dose (except toxicity ≤Grade 2 [CTCAE v5.0], alopecia/vitiligo permitted).
- •13.CNS Metastases: Active/untreated CNS or leptomeningeal metastases (asymptomatic brain metastases allowed).
- •14.Uncontrolled Hypertension: Resting SBP ≥160 mmHg and/or DBP ≥100 mmHg (two measurements, 2h apart).
- •15.Active Infections:
- •HIV seropositivity
- •Active HBV (HBsAg+ andHBV DNA >LLOQ)
- •Active HCV (anti-HCV+ andHCV RNA >LLOQ) 16.Live Vaccines: Live attenuated vaccines ≤4 weeks pre-dose (COVID-19 vaccines permitted except Ad5-vectored type [requires investigator assessment]).
- •17.Concurrent Clinical Trials: Participation in other drug/device trials ≤4 weeks pre-dose or planned during study.
- •18.Investigator's Discretion: Poor compliance or other factors deemed unsuitable for the study.
研究组 & 干预措施
Dose Escalation
Experimental
For single dose escalation, the dose level will be 2µg/kg -15 µg/kg.
干预措施: Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein (Biological)
Dose Expansion - Group A: First-line CIT treatment / Prophylactic administration for CIT (as needed)
Experimental
The dose level is recommended to be the bioeffective dose obtained from dose escalation and administered once weekly (group A) , with a total of no more than 4 administrations within 70 days after the first dose.
干预措施: Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein (Biological)
Dose Expansion - Group B: Previously treated or refractory CIT
Experimental
The dose level is recommended to be the bioeffective dose obtained from dose escalation and administered once weekly ( group B ), with a total of no more than 4 administrations within 70 days after the first dose.
干预措施: Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein (Biological)
结局指标
主要结局
Dose escalation: Occurrence of DLT.
时间窗: Occurrence of DLT from enrollment to day 21.
Occurrence of DLT
Dose escalation: Frequency of DLT.
时间窗: Frequency of DLT from enrollment to day 21.
Frequency of DLT
Dose escalation and Dose expansion:Occurrence of AE.
时间窗: 28 days after the last administration of SCB-219M
number, frequency,and charaterization of AEs
次要结局
- Dose escalation: Cmax(up to 21 days after treatment)
- Dose escalation: Cmax/D(up to 21 days after treatment)
- Dose escalation: tmax(up to 21 days after treatment)
- Dose escalation: AUC0-24h(up to 21 days after treatment)
- Dose escalation: AUC0-last(up to 21 days after treatment)
- Dose escalation: AUC0-inf(up to 21 days after treatment)
- Dose escalation: t1/2(up to 21 days after treatment)
- Dose escalation: CL/F(up to 21 days after treatment)
- Dose escalation: Vz/F(up to 21 days after treatment)
- Dose escalation: λz(up to 21 days after treatment)
- Dose escalation: Preliminary efficacy assessment.The percentage of subjects requiring platelet infusion and the frequency of infusion during the DLT observation period.(up to 28 days after administration)
- Dose escalation: Preliminary efficacy assessment.(up to 28 days after administration)
- Dose expansion:：PK parameters of SCB-219M were established after repeated abdominal subcutaneous injections.(up to 168 hours after the last treatment)
- Dose expansion: Preliminary efficacy assessment.(Within 7, 14, 21, and 28 calendar days post-administration)
- Dose expansion: ：Platelet response onset time (days), duration of platelet effect maintenance (days), and overall response rate (%).(28 days after the last administration of SCB-219M)
研究者
研究点 (1)
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