NCT06854276

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy-induced Anemia
• Non-myeloid Malignancies

Interventions

Type	Name	Description
DRUG	SSS06	SSS06 is a highly glycosylated, long-acting recombinant protein product produced through recombinant gene technology by introducing site-specific mutations into the rHuEPO gene.
DRUG	rhEPO	a recombinant human erythropoietin injection.

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-03-03
• Last updated: 2025-03-03