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Study of SSS06 for Chemotherapy-Induced Anemia in Non-Myeloid Malignancies | Clinical Trials | Clareo Health

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Study of SSS06 for Chemotherapy-Induced Anemia in Non-Myeloid Malignancies

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

NCT06854276•Shenyang Sunshine Pharmaceutical Co., LTD.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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).
+12 more criteria

Key Dates

Start Date

March 1, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

March 3, 2025

Enrollment

ESTIMATED participants

Conditions

Chemotherapy-induced AnemiaNon-myeloid Malignancies

Interventions

SSS06

DRUG

rhEPO

DRUG