Chemotherapy-induced AnemiaPhase 2NCT06854276
Study of SSS06 for Chemotherapy-Induced Anemia in Non-Myeloid Malignancies
A Phase 2 study testing SSS06 and rhEPO in people with Chemotherapy-induced Anemia and Non-myeloid Malignancies, run by Shenyang Sunshine Pharmaceutical Co., LTD..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Anemia, Non-myeloid Malignancies
- What is being tested?
- SSS06 and rhEPO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
About this study
Official title: 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
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.
- Being tested
- SSS06, rhEPO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSS06Drug
SSS06 is a highly glycosylated, long-acting recombinant protein product produced through recombinant gene technology by introducing site-specific mutations into the rHuEPO gene.
rhEPODrug
Also called Yibiao
a recombinant human erythropoietin injection.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | SSS06, 200 μg, administered every 3 weeks, given 4 times Receives: Drug: SSS06 |
| medium-dose group | Experimental | SSS06, 500 μg, administered every 3 weeks, given 4 times Receives: Drug: SSS06 |
| high-dose group | Experimental | SSS06, 800 μg, administered every 3 weeks, given 4 times Receives: Drug: SSS06 |
| Positive control group | Placebo comparator | EPO, 36000 IU, administered every weeks, given 12 times Receives: Drug: rhEPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Events (NCI-CTCAE V5.0).
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).
Measured: From Day 1 to Day 113
Secondary outcomes (1)
Concentration of hemoglobin maximum change from baseline
the maximum change in Hb from baseline within 13 weeks without red blood cell transfusion.
Measured: From Day 1 to Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854276
- Sponsor's protocol ID
- SSS06-202
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No