Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT05426369
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18-75 years (inclusive), voluntary participation with signed informed consent and commitment to protocol-defined visits.
2. Body Weight: ≥40 kg.
3. Diagnosis: Histopathologically/cytopathologically confirmed malignant solid tumors or lymphoma.
4. Phase Ia: Platelet (PLT) \& Treatment Status:
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1. PLT \<75×10⁹/L during prior chemotherapy cycle;
2. Receiving mono/combination chemotherapy (may include targeted/immunotherapy). 5.Phase Ib: Stratified Requirements:
* Group A (1st-line CIT prophylaxis/therapy):
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1. PLT \<50×10⁹/L, or
2. 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: 0-2. 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.
Exclusion Criteria:
1. Pregnancy/Lactation: Pregnant or breastfeeding females.
2. Hypersensitivity: Known allergy to protein-based drugs (e.g., recombinant proteins, mAbs) or excipients of the investigational product.
3. Active Infection: Acute infection requiring IV antibiotics without clinical control.
4. 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
5. Anticoagulant Use: Anticoagulants/antiplatelet drugs ≤5 half-lives pre-dose or needed during study (aspirin washout ≥7 days).
6. Non-Chemotherapy Thrombocytopenia (within 6 months/unresolved):
1\) 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05426369
Study Brief:
Protocol Section:
NCT05426369