Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Pemetrexed

Cisplatin

BLEX 404

Uttam Patil, Ph.D.

Yung-Hung Luo

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.

Phase I: A 3+3 design with dose escalation to determine the dose-limiting toxicity (DLT) and recommended dose level (RDL) in the first cycle of combination use with Pemetrexed + Cisplatin Therapy.

Phase II: A following study to determine the efficacy while using the RDL of BLEX 404 Oral Liquid combined with Pemetrexed + Cisplatin Therapy in a total of 20 stage-IV or recurrent non-small cell lung cancer patients.

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

A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of BLEX 404Oral Liquid Combined With Pemetrexed + Cisplatin Therapy in Patients With Advanced Inoperable or Metastatic EGFR Wild-type Non-Small Cell Lung Cancer Patients

To determine the dose-limiting toxicity (DLT) in the first cycle of combination use

To determine the recommended dose level (RDL) in the first cycle of combination use

Overall response rate (PR + CR) after 4 cycles of combination use in BLEX 404

+ Pemetrexed \& Cisplatin Therapy.

Overall response rate (PR + CR) after at least 1 cycle of combination use in BLEX 404

+ Pemetrexed \& Cisplatin Therapy.

AEs that occur during the study will be rated by using the grades defined in Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. There are 5 grades, includes Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life threatening) and Grade 5 (Death).

EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. A negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement.

American BriVision Corporation

Rgene Corporation

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gemcitabine

During Phase I study (dose escalation), a standard 3+3 design will be followed, and the dose range is 3 to 10 mg/kg BID. The recommended dose level (RDL) for the Phase II study is defined as the dose level with 0 to 1 DLT observed during cycle I of Gemcitabine monotherapy among 6 patients in the Phase I study.

BLEX 404 Oral Liquid is administered twice daily during the Gemcitabine monotherapy period. The dose of Gemcitabine 1,000 mg/m2 IV fusion at Day 1, 8, 15 of every cycle

* 28 days a cycle.

Frank C. Liu

Gi-Ming Lai, M.D.

The primary purpose of this study is to determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy in a 28-day schedule.The secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy at the recommended dose.

Study Objectives Part I To determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy in a 28-day schedule.

Part II To assess the efficacy and safety of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy at the recommended dose.

A Phase II, EvaluateBLEX 404 Combined With Gemcitabine Monotherapy With Pancreatic Cancer

A Phase II, Open Label Study to Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Gemcitabine Monotherapy in Patients With Advanced Inoperable or Metastatic Pancreatic Cancer

Presence or absence of dose-limiting toxicity (DLT) related to BLEX 404 Oral Liquid for each patient during first cycle of Gemcitabine monotherapy to determine the recommended dose level (RDL).

Overall response rate (PR + CR) after 4 cycles of combination use in BLEX 404 + Gemcitabine monotherapy.

1. Overall benefit rate (CR + PR + SD) after at least 3 cycles of combination use of BLEX 404 plus Gemcitabine monotherapy.

Rate of grade 3/4 hematological toxicity of each cycle.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Pemetrexed + Cisplatin Therapy	NCT05764928	Nonsquamous Non...	BLEX 404	20 Years - 70 Years	Rgene Corporation
A Phase II, EvaluateBLEX 404 Combined With Gemcitabine Monotherapy With Pancreatic Cancer	NCT03301805	Pancreatic Canc...	BLEX 404	20 Years - 80 Years	Rgene Corporation

Spots Global Cancer Trial Database for blex 404

Every month we try and update this database with for blex 404 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for blex 404

Every month we try and update this database with for blex 404 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for blex 404 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.