Study of SSS06 for Chemotherapy-Induced Anemia in Non-Myeloid Malignancies
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenyang Sunshine Pharmaceutical Co., LTD.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SSS06
- rhEPO
Treatment groups
80 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov