Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BLEX 404 · 2 trials · 2 indications
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.
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 | 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. |
| 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 | 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: 1. Patients aged 20 - 80 years old at the time of signing the ICF. 2. Patients with pathologically proved adenocarcinoma of pancreatic cancer and diagnosed with inoperable/metastatic disease (previous systemic chemotherapy, neoadjuvant or adjuvant gemcitabine are acceptable, unl...
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BLEX 404 is an investigational small molecule being developed for the treatment of nonsquamous nonsmall cell lung cancer and pancreatic cancer. It is currently in clinical development for these oncology indications.
BLEX 404 is being developed by ABVC BioPharma, Inc., a company listed on the stock exchange under the ticker symbol ABVC.
BLEX 404 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy.
BLEX 404 is being studied in two clinical trials. One trial (NCT03301805) is a Phase 2 study evaluating BLEX 404 combined with gemcitabine in pancreatic cancer. Another trial (NCT05764928) is a Phase 1 study evaluating BLEX 404 oral liquid combined with pemetrexed and cisplatin in nonsquamous nonsmall cell lung cancer.
Yes, BLEX 404 is being studied in combination with other anticancer agents. In pancreatic cancer, it is combined with gemcitabine. In nonsquamous nonsmall cell lung cancer, it is combined with pemetrexed and cisplatin.
BLEX 404 is also known as BLEX 404. No other alternative names have been reported for this investigational drug.