Approval Probability
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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 oral liquid being studied for the treatment of Myelodysplastic Syndrome (MDS) and Triple Negative Breast Cancer. It is a small molecule developed by ABVC BioPharma, Inc. (NASDAQ: ABVC). The drug is currently in Phase 2 clinical development for these indications.
BLEX 404 is a small molecule, but its specific molecular target has not been disclosed in available information. The drug is being evaluated in clinical trials for its safety and efficacy in treating Myelodysplastic Syndrome and Triple Negative Breast Cancer, though the exact mechanism of action is not publicly detailed.
BLEX 404 is being developed by ABVC BioPharma, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ABVC. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Myelodysplastic Syndrome and Triple Negative Breast Cancer.
BLEX 404 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The company is currently conducting trials to assess its safety and efficacy in treating Myelodysplastic Syndrome and Triple Negative Breast Cancer.
BLEX 404 is involved in two clinical trials. NCT02944955 is a Phase 2 study in patients with Myelodysplastic Syndrome, with an enrollment of 52 participants. NCT02802423 is a Phase 1/2 study combining BLEX 404 with docetaxel in patients with advanced or metastatic Triple Negative Breast Cancer, enrolling 44 participants. Both trials are not yet recruiting.
Yes, BLEX 404 Liquid is also known as BLEX 404 Oral Liquid. Both names refer to the same investigational drug developed by ABVC BioPharma, Inc. The drug is being studied in oral liquid form for the treatment of Myelodysplastic Syndrome and Triple Negative Breast Cancer.