Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BLEX 404 Oral Liquid, BLEX 404 Liquid
BLEX 404 · 4 trials · 4 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 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.
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.
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.
| 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. |
| Phase I: 1.5 mg/kg BLEX404 | EXPERIMENTAL | Oral administration BID |
| Phase I: 3.0 mg/kg BLEX404 | EXPERIMENTAL | Oral administration BID |
| Phase I: 6.0 mg/kg BLEX404 | EXPERIMENTAL | Oral administration BID |
| Phase II: RDL of BLEX 404 | EXPERIMENTAL | Oral administration BID |
| 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. |
| BLEX 404 | DRUG | 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. |
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 is an investigational oral liquid small molecule developed by ABVC BioPharma, Inc. It is being studied in several cancer and blood conditions, including myelodysplastic syndrome, nonsquamous nonsmall cell lung cancer, pancreatic cancer, and triple negative breast cancer. It is in Phase 2 clinical development and has not been approved for any indication.
BLEX 404 is being studied for myelodysplastic syndrome, nonsquamous nonsmall cell lung cancer, pancreatic cancer, and triple negative breast cancer. These are investigational uses only. The drug has not been approved for any indication and remains in clinical development.
BLEX 404 is developed by ABVC BioPharma, Inc., which trades under the ticker ABVC. The company is the sponsor of the clinical program studying the oral liquid small molecule across hematology and oncology indications.
BLEX 404 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency for any indication. Trials in the program have been listed at both Phase 1 and Phase 2.
BLEX 404 has been studied in trials including NCT02944955 in myelodysplastic syndrome and chronic myelomonocytic leukemia, NCT03301805 in pancreatic cancer, NCT02802423 in triple negative breast cancer, and NCT05764928 in nonsquamous nonsmall cell lung cancer combined with pemetrexed and cisplatin.
Yes. BLEX 404 Oral Liquid and BLEX 404 Liquid are alternative names for BLEX 404, the investigational small molecule developed by ABVC BioPharma, Inc. Searches using any of these names refer to the same drug candidate in clinical development.