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

NCT03301805 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

BLEX 404

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.

Sponsors & Collaborators

  • American BriVision Corporation

    collaborator UNKNOWN

  • Rgene Corporation

    lead INDUSTRY

Principal Investigators

  • Gi-Ming Lai, M.D. · Taipei Municipal Wanfang Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-04-30
Completion
2027-06-30
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03301805 on ClinicalTrials.gov