NCT06854276尚未招募2 期
A Randomized, Open-Label, Active-Controlled, Multicenter Phase II/III Clinical Study to Evaluate the Safety and Efficacy of SSS06 in the Treatment of Chemotherapy-Induced Anemia in Patients with Non-Myeloid Malignancies
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Events (NCI-CTCAE V5.0).
研究概览
简要总结
This study employs a multicenter, randomized, open-label, positive drug-controlled, multiple ascending dose clinical trial design to comprehensively evaluate the safety, tolerability, immunogenicity, and pharmacokinetic characteristics of SSS06 injection in patients with chemotherapy-induced anemia from non-myeloid malignancies, while also exploring its potential efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged ≥18 years at the time of signing the informed consent.
- •Histologically or cytologically confirmed diagnosis of non-myeloid malignancies.
- •Chemotherapy-induced anemia defined as hemoglobin (Hb) ≤100 g/L at screening, with a documented decrease in Hb of ≥10 g/L post chemotherapy initiation, as judged by the investigator.
- •Serum ferritin ≥50 ng/mL and transferrin saturation (TSAT) ≥10% at screening.
- •Body weight ≥40 kg at screening.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or 2 at screening.
- •Expected survival ≥6 months.
- •Planned to receive at least 8 weeks of myelosuppressive chemotherapy starting from Day 1 of the study.
- •Childbearing women must agree to use reliable contraception and have no plans to conceive or donate eggs from the start of study drug administration until 6 months post-last dose. Men must agree to use reliable contraception and have no plans to father a child or donate sperm from the start of study drug administration until 6 months post-last dose.
- •Voluntarily sign informed consent, willing to participate in the trial, and able to comply with the protocol requirements for administration and follow-up, including examinations, visits, and other procedures.
排除标准
- •Patients undergoing myelosuppressive chemotherapy with an expected curative outcome.
- •Subjects receiving only hormone therapy, biologics, immunosuppressants (e.g., PD-1 and PD-L1 immune checkpoint inhibitors), or targeted therapies, or radiation therapy to treat/control their tumors; however, subjects receiving chemotherapy in combination with these therapies may be included.
- •Subjects with a hematocrit (HCT) ≥ 36%.
- •Subjects who have undergone interventions (e.g., blood transfusion, erythropoiesis-stimulating agents (ESAs), or hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs)) to elevate hemoglobin (Hb) levels to meet chemotherapy safety standards prior to the initiation of the scheduled chemotherapy regimen.
- •Subjects who received red blood cell (RBC) transfusions, ESAs, or HIF-PHIs within 4 weeks prior to enrollment.
- •Subjects with abnormal liver or kidney function test results: alanine aminotransferase (ALT) > 3×ULN, aspartate aminotransferase (AST) > 3×ULN, or total bilirubin (TBL) > 1.5×ULN (subjects with TBL up to 2×ULN may be included if ALT/AST are within normal limits and the investigator deems no safety concerns). Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² (calculated using the CKD-EPI formula).
- •Subjects with active systemic infections requiring treatment.
- •Subjects with a history of clinically significant cardiovascular disease, including New York Heart Association (NYHA) Class III or IV heart failure within the past 6 months, uncontrolled hypertension or hypotension, or severe valvular or endocardial disease history that may increase the risk of thromboembolic events.
- •Subjects who experienced thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack) within the past 6 months.
- •Subjects with clinically significant anemia due to other causes, such as iron deficiency, vitamin B12 or folate deficiency, autoimmune anemia, hemolysis, hemorrhage, or genetic anemias (e.g., sickle cell anemia or thalassemia).
- •Subjects with clinically significant or uncontrolled chronic inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, Crohn's disease, celiac disease).
- •Subjects with severe or active liver disease.
- •Subjects planning to undergo major surgery during the treatment period (surgery with minimal blood loss that does not affect Hb concentration is exempt).
- •Subjects with myeloid malignancies.
- •Subjects with primary or metastatic malignant tumors in the central nervous system.
- •Subjects testing positive for human immunodeficiency virus (HIV) antibodies or syphilis antibodies.
- •Subjects positive for hepatitis B virus (HBV) or hepatitis C virus (HCV):
- •Subjects with inactive HBsAg carriers or stable hepatitis B patients (HBV DNA < 500 IU/mL) may be included, with regular monitoring of HBV DNA during the study as recommended by the investigator.
- •Subjects with HCV antibody positivity (HCV-Ab+) may be included if HCV RNA is negative, with regular monitoring of HCV RNA during the study as recommended by the investigator.
- •Subjects who have used any investigational drugs within 4 weeks prior to Day 1 of treatment or plan to use such drugs during the clinical trial.
- •Subjects with a history of alcoholism, drug abuse, or addiction.
- •Subjects deemed unsuitable for participation in the study by the investigator.
研究组 & 干预措施
Low-dose group
Experimental
SSS06, 200 μg, administered every 3 weeks, given 4 times
干预措施: SSS06 (Drug)
medium-dose group
Experimental
SSS06, 500 μg, administered every 3 weeks, given 4 times
干预措施: SSS06 (Drug)
high-dose group
Experimental
SSS06, 800 μg, administered every 3 weeks, given 4 times
干预措施: SSS06 (Drug)
Positive control group
Placebo Comparator
EPO, 36000 IU, administered every weeks, given 12 times
干预措施: rhEPO (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Events (NCI-CTCAE V5.0).
时间窗: From Day 1 to Day 113
All adverse events occurring during the entire study period will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE Version 5.0).
次要结局
- Concentration of hemoglobin maximum change from baseline(From Day 1 to Day 113)
研究者
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