Not Yet RecruitingPhase 2

A Phase II, EvaluateBLEX 404 Combined With Gemcitabine Monotherapy With Pancreatic Cancer

40 participantsStarted 2026-07-01

Plain-language summary

The primary purpose of this study is to determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy in a 28-day schedule.The secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy at the recommended dose.

Who can participate

Age range20 Years – 80 Years

SexALL

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Inclusion criteria

✓. Patients aged 20 - 80 years old at the time of signing the ICF.

Exclusion criteria

✕. Eastern Cooperative Oncology Group (ECOG) performance status of 1 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).
✕. Adequate hepatic function defined as: serum 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 with: serum creatinine =\< 1.3 mg/dL or 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-child bearing 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 Gemcitabine monotherapy.
✕0. Willing and able to comply with all aspects of the treatment protocol.

What they're measuring

Part I: Dose-limiting toxicity (DLT) observation

Timeframe: 4 weeks (1 cycle)

Part II: Overall response rate (PR + CR)

Timeframe: 12 weeks (3 cycle)

Trial details

NCT IDNCT03301805

SponsorRgene Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Frank C. Liu

+886-2-87518701 liu3763@bioliteinc.com

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