Nonsquamous Nonsmall Cell Neoplasm of LungPhase 1/2NCT05764928
Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Pemetrexed + Cisplatin Therapy
A Phase 1/2 study testing BLEX 404 in people with Nonsquamous Nonsmall Cell Neoplasm of Lung, run by Rgene Corporation at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonsquamous Nonsmall Cell Neoplasm of Lung
- What is being tested?
- BLEX 404
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2026to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 20 - 70 years old at the time of signing the ICF.
- Naïve patients with histologically or pathologically diagnosed with Advanced Inoperable or Metastatic non-small cell lung cancer and intended for first line treatment.
- Patients with histologically or pathologically diagnosed with nonsquamous non-small cell lung cancer who are: EGFR wild-type (no EGFR gene mutation)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate hematologic function defined as: absolute neutrophil count (ANC)
- ≥ 2,000/μL; platelets count ≥ 100,000/μL; hemoglobin must be ≥10 g/dL (can be corrected by growth factor or transfusion).
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- Adequate hepatic function defined as: serum total bilirubin ≤ 1.5-fold upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3-fold ULN (5- fold ULN if liver metastasis is observed).
- Adequate renal function: calculated creatinine clearance ≥ 60 mL/minute according to the Cockcroft and Gault formula.
- At least one measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Women must be either of non-childbearing potential, or women with child- bearing potential agree to use effective a highly contraceptive method or a contraceptive implant, exception of hormonal contraception (estrogen/progesterone), during treatment from time of Screening Visit and after cessation of therapy at least 3 months.
- Planning to receive Pemetrexed + Cisplatin Therapy.
- Willing and able to comply with all aspects of the treatment protocol.
- Provide written informed consent.
Who cannot join
- Women who are pregnant or breast feeding.
- Patients with brain metastasis but asymptomatic need not be excluded.
- Patients with autoimmune disease that requires systemic steroids or immunosuppression agents.
- Current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent.
- Patients with following treatment prior to Pemetrexed + Cisplatin Therapy: chemotherapy, immunotherapy, or biologic systemic anticancer therapy within 21 days of study entry (42 days for mitomycin and nitrosoureas); prior received taxanes in adjuvant therapy within 12 months; prior received polysaccharide-based drugs within 6 months; radiation therapy within 28 days (90 days for bone marrow exposure 20%); hormonal therapy within 28 days.
- Known history of human immunodeficiency virus (HIV) infection.
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- Existing anticancer treatment-related toxicities of Grades ≥ 2 (except for alopecia and neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE v5.0).
- Patients with Grade > 2 neuropathy.
- Patients with an active infection requiring systemic therapy.
- Patients with active liver disease, such as hepatitis C virus (HCV) carriers, and/or those with active viral disease which is defined as hepatitis B virus (HBV)carriers with HBV DNA > 2,000 IU/ml plus AST and ALT > 3-fold ULN, other liver viral disease or autoimmune liver disease.
- History of concomitant medical conditions or infectious diseases that, in the opinion of the investigator, would compromise the patient's ability to safely complete the study.
- Clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT/QTc ([QT interval/corrected QT interval] of a QTc interval >450 ms. (referred to Subject enrollment 2.1.1 E14 clinical Evaluation of QT/QTC).
- Ascertained hypersensitivity to investigational product, Pemetrexed or any of the excipients used in the study.
- Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily BLEX 404 Oral Liquid treatment.
- Judged to be not applicable to this study by investigator such as difficulty of follow-up observation, psychiatric disorder, with any other serious diseases/medical history.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Being tested
- BLEX 404
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLEX 404Drug
BLEX 404 Oral Liquid, PO, BID
| Study group | Role | What they receive |
|---|---|---|
| Phase I: 1.5 mg/kg BLEX404 | Experimental | Oral administration BID Receives: Drug: BLEX 404 |
| Phase I: 3.0 mg/kg BLEX404 | Experimental | Oral administration BID Receives: Drug: BLEX 404 |
| Phase I: 6.0 mg/kg BLEX404 | Experimental | Oral administration BID Receives: Drug: BLEX 404 |
| Phase II: RDL of BLEX 404 | Experimental | Oral administration BID Receives: Drug: BLEX 404 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT determination
To determine the dose-limiting toxicity (DLT) in the first cycle of combination use
Measured: end of 21 days
RDL Determination
To determine the recommended dose level (RDL) in the first cycle of combination use
Measured: end of 21 days
Overall response rate (PR + CR) after 4 cycles of combination use
Overall response rate (PR + CR) after 4 cycles of combination use in BLEX 404
+ Pemetrexed \& Cisplatin Therapy.
Measured: end of 84 days
Secondary outcomes (3)
Overall response rate (PR + CR) after at least 1 cycle of combination use
Overall response rate (PR + CR) after at least 1 cycle of combination use in BLEX 404
+ Pemetrexed \& Cisplatin Therapy.
Measured: end of 126 days
Rate of grade 3/4 hematological toxicity
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).
Measured: end of 126 days
Effect on Quality of Life by EORTC QLQ-C30
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.
Measured: end of 126 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsquamous Nonsmall Cell Neoplasm of LungStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American BriVision Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764928
- Sponsor's protocol ID
- RGC-1501-001
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2023
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05764928
- Acronym / sponsor ID
- RGC-1501-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Rgene CorporationIndustry (pharma, biotech, devices)
- Collaborators
- American BriVision Corporation
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phase I: 1.5 mg/kg BLEX404 | Experimental | Drug: BLEX 404Oral administration BID |
| Phase I: 3.0 mg/kg BLEX404 | Experimental | Drug: BLEX 404Oral administration BID |
| Phase I: 6.0 mg/kg BLEX404 | Experimental | Drug: BLEX 404Oral administration BID |
| Phase II: RDL of BLEX 404 | Experimental | Drug: BLEX 404Oral administration BID |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients aged 20 - 70 years old at the time of signing the ICF.
- Naïve patients with histologically or pathologically diagnosed with Advanced Inoperable or Metastatic non-small cell lung cancer and intended for first line treatment.
- Patients with histologically or pathologically diagnosed with nonsquamous non-small cell lung cancer who are: EGFR wild-type (no EGFR gene mutation)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate hematologic function defined as: absolute neutrophil count (ANC)
Key exclusion criteria (15 listed)
- Women who are pregnant or breast feeding.
- Patients with brain metastasis but asymptomatic need not be excluded.
- Patients with autoimmune disease that requires systemic steroids or immunosuppression agents.
- Current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent.
- Patients with following treatment prior to Pemetrexed + Cisplatin Therapy: chemotherapy, immunotherapy, or biologic systemic anticancer therapy within 21 days of study entry (42 days for mitomycin and nitrosoureas); prior received taxanes in adjuvant therapy within 12 months; prior received polysaccharide-based drugs within 6 months; radiation therapy within 28 days (90 days for bone marrow exposure 20%); hormonal therapy within 28 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLEX 404BLEX 404 Oral Liquid, PO, BID | Drug | Phase I: 1.5 mg/kg BLEX404, Phase I: 3.0 mg/kg BLEX404, Phase I: 6.0 mg/kg BLEX404, Phase II: RDL of BLEX 404 |
Primary outcome
DLT determination
Time frame: end of 21 days
To determine the dose-limiting toxicity (DLT) in the first cycle of combination use
RDL Determination
Time frame: end of 21 days
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
Time frame: end of 84 days
Overall response rate (PR + CR) after 4 cycles of combination use in BLEX 404 + Pemetrexed \& Cisplatin Therapy.
3 secondary outcomes
Overall response rate (PR + CR) after at least 1 cycle of combination use
Time frame: end of 126 days
Rate of grade 3/4 hematological toxicity
Time frame: end of 126 days
Effect on Quality of Life by EORTC QLQ-C30
Time frame: end of 126 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BLEX 404 in people with Nonsquamous Nonsmall Cell Neoplasm of Lung, run by Rgene Corporation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uttam Patil, Ph.D. (+886-2-25642839 ext. 211, uttampatil23@biorgene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT determination (time frame: end of 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.