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Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Pemetrexed + Cisplatin Therapy

NCT05764928 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-04-20

No results posted yet for this study

Summary

Maitake is reported with immunomodulatory functions against tumor growth in terms of its unique molecular structure, β-glucan polysaccharides within 1, 6 main chain having 1, 3 branches and a 1, 3 main chain having 1, 6 branches configuration. The β-glucan is identified as a main component of BLEX 404. Not only with therapeutic potential on several types of cancer, BLEX 404 has also shown the potential to improve hematopoiesis, granulocyte colony stimulating factor (G-CSF) production, and the cytotoxicity activity of immune cells in recent animal studies. Its antitumor effect on tumor-bearing mice is exerted by enhancing the immune system through activation of macrophages, T cells, and natural killer (NK) cells.

The activation of antigen presenting cells (APCs) such as macrophages, dendritic cells (DCs) via BLEX 404 administration is in response to secretion of interleukin-12 (IL-12). BLEX 404 has been found to enhance the activity of immunocompetent cells such as helper T cells, cytotoxic T cells, and NK cells either by i.p injection or oral intake, therefore, it stimulates innate and adaptive immunity. BLEX 404 enhances hematopoiesis by increasing mouse bone marrow cell and human cord blood cell differentiation into granulocytes-macrophages (GMs), granulopoiesis and mobilization of granulocytes, and granulocyte macrophage colony-stimulating factor (GM-CSF) or G-CSF production. One related phase I healthy human trial by treating with Maitake D-fraction was examined in Italy. The published data of trial for solid tumor patients was in the year 2003 in Japan, and another for breast cancer patients was in the year 2009 in the United States executed by Memorial Sloan Kettering Cancer Center (MSKCC). Lately, same team amended IND for myelodysplastic syndromes (MDS) human trial. All those human experiences are the fundamental of developing BLEX 404 Oral Liquid.

Conditions

  • Nonsquamous Nonsmall Cell Neoplasm of Lung

Interventions

DRUG

BLEX 404

BLEX 404 Oral Liquid, PO, BID

Sponsors & Collaborators

  • American BriVision Corporation

    collaborator UNKNOWN

  • Rgene Corporation

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05764928 on ClinicalTrials.gov