Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BLEX 404 Oral Liquid
BLEX 404 Liquid · 2 trials · 2 indications
RDL is defined by BLEX 404 Oral Liquid-related prohibited toxicity in subjects undergoing 2 cycles of azacitidine treatment. When one of the stopping criteria is met during the study treatment period, RDL will be set at the lower dose level.
Number of subjects experience infection events and inpatient hospitalization due to infections.
Presence or absence of dose-limiting toxicity (DLT) related to BLEX 404 Oral Liquid for each patient during first cycle of Docetaxel monotherapy to determine the recommended dose level (RDL).
Overall response rate (PR + CR) after 4 cycles of combination use in BLEX 404 + Docetaxel monotherapy.
| Arm | Type | Description |
|---|---|---|
| BLEX 404 Oral Liquid | EXPERIMENTAL | Part I: Part I-1: Low Dose BLEX 404 Oral Liquid (3 mg/kg, BID) is administered in combination with 2 cycles of azacitidine. Part I-2: High Dose BLEX 404 Oral Liquid (4.5 mg/kg, BID) is administered in combination with 2 cycles of azacitidine. Part II: Recommended Dose Level (RDL) of BLEX 404 Oral Liquid will be determined by results from Part I. BLEX 404 Oral Liquid at RDL is administered in combination with 6 cycles of azacitidine. |
| Name | Type | Description |
|---|---|---|
| BLEX 404 Oral Liquid | DRUG | BLEX 404 Oral Liquid is orally administered twice daily in combination with azacitdine treatment cycles (2 cycles in Part I and 6 cycles in Part II). Azacitidine treatment: SC or IV injections at 75 mg/m2, QD for 7 days each cycle. 28 days/cycle, and repeat cycles every 4 weeks. |
Inclusion Criteria: * Age 20 or older, able to sign informed consent, understand and comply with protocol requirements and instructions. * Body weight between 30 to 120 kg * International Prognostic Scoring System (IPSS) intermediate-1 (int-1), intermediate-2 (int-2) or high-risk myelodysplastic sy...
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BLEX 404 Liquid is an investigational small molecule being developed for Myelodysplastic Syndrome (MDS) and Triple Negative Breast Cancer. It is currently in Phase 2 clinical development for these indications. The drug is being studied in patients with advanced or metastatic Triple Negative Breast Cancer and in patients with intermediate-1, intermediate-2, or high-risk MDS.
BLEX 404 is a small molecule, but its specific molecular target has not been disclosed. It is being studied for its safety and efficacy in combination with docetaxel in Triple Negative Breast Cancer and as a monotherapy in Myelodysplastic Syndrome. The drug is in Phase 2 clinical trials for these indications.
BLEX 404 is being developed by ABVC BioPharma, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Myelodysplastic Syndrome and Triple Negative Breast Cancer. ABVC BioPharma is listed on the stock exchange under the ticker symbol ABVC.
BLEX 404 is in Phase 2 clinical development. It is being studied in two indications: Myelodysplastic Syndrome and Triple Negative Breast Cancer. The drug is not yet approved by regulatory authorities and remains investigational. Clinical trials are ongoing to evaluate its safety and efficacy in these patient populations.
BLEX 404 is being studied in two clinical trials. NCT02944955 is a Phase 2 study of BLEX 404 Oral Liquid in patients with Myelodysplastic Syndrome, with an enrollment of 52 participants. NCT02802423 is a Phase 1/2 study of BLEX 404 with docetaxel in patients with advanced or metastatic Triple Negative Breast Cancer, with an enrollment of 44 participants.
Yes, BLEX 404 Liquid and BLEX 404 Oral Liquid refer to the same investigational drug. The drug is being developed by ABVC BioPharma, Inc. for the treatment of Myelodysplastic Syndrome and Triple Negative Breast Cancer. It is currently in Phase 2 clinical trials for these indications.