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SSS06

Phase 2

Chemotherapy-induced Anemia | Small molecule | Oncology |Sunshine Biopharma Inc.|Last Updated: Mar 3, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

SSS06 · 1 trial · 2 indications

Phase 2 1
NCT06854276Study of SSS06 for Chemotherapy-Induced Anemia in Non-Myeloid MalignanciesChemotherapy-induced Anemia
NOT YET_RECRUITING80 Analytics
PHASE2NOT YET_RECRUITING
Study of SSS06 for Chemotherapy-Induced Anemia in Non-Myeloid Malignancies
Chemotherapy-induced AnemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Events (NCI-CTCAE V5.0).
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).

Secondary Endpoints

Concentration of hemoglobin maximum change from baseline
From Day 1 to Day 113
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low-dose groupEXPERIMENTALSSS06, 200 μg, administered every 3 weeks, given 4 times
medium-dose groupEXPERIMENTALSSS06, 500 μg, administered every 3 weeks, given 4 times
high-dose groupEXPERIMENTALSSS06, 800 μg, administered every 3 weeks, given 4 times
Positive control groupPLACEBO_COMPARATOREPO, 36000 IU, administered every weeks, given 12 times

Interventions

NameTypeDescription
SSS06DRUGSSS06 is a highly glycosylated, long-acting recombinant protein product produced through recombinant gene technology by introducing site-specific mutations into the rHuEPO gene.
rhEPODRUGa recombinant human erythropoietin injection.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

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...

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Frequently asked questions about SSS06

What is SSS06 used for?

SSS06 is an investigational small molecule being developed for chemotherapy-induced anemia in patients with non-myeloid malignancies. It is currently in Phase 2 clinical development and has not been approved by the FDA.

How does SSS06 work?

SSS06 is a small molecule designed to treat chemotherapy-induced anemia. Its specific molecular target has not been disclosed in available clinical trial information.

Who is developing SSS06?

SSS06 is being developed by Sunshine Biopharma Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SBFM.

What phase is SSS06 in?

SSS06 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval.

What clinical trials is SSS06 in?

SSS06 is being studied in a Phase 2 trial (NCT06854276) for chemotherapy-induced anemia in non-myeloid malignancies. This randomized, double-blind, placebo-controlled trial plans to enroll 80 participants aged 18 years and older.

Is SSS06 FDA approved?

No, SSS06 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for chemotherapy-induced anemia.