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

NCT03301805 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: RGC-1502-01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Part I: Dose-limiting toxicity (DLT) observation

  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).

  4 weeks (1 cycle)

• Part II: Overall response rate (PR + CR)

  Overall response rate (PR + CR) after 4 cycles of combination use in BLEX 404 + Gemcitabine monotherapy.

  12 weeks (3 cycle)

Secondary Outcomes (2)

• Part II: Overall benefit rate (CR + PR + SD)

  12 weeks (3 cycle)

• Part II: Incidence of grade 3/4 hematological toxicity

  4 weeks (1 cycle)

Study Arms (1)

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.

Drug: BLEX 404

Interventions

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.

BLEX 404 Oral Liquid

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Willing and able to comply with all aspects of the treatment protocol.
• Provide written informed consent.
• Patients with following treatment prior to Gemcitabine monotherapy: chemotherapy, immunotherapy, or biologic systemic anticancer therapy within 28 days of study entry.
• Pancreatic patients with prior history of Gemcitabine chemotherapy.
• Women who are pregnant or breastfeeding.
• Patients with brain metastasis.
• Patients with bone metastasis alone.
• Patients with autoimmune disease that requires systemic steroids or immunosuppression agents.

Sponsors & Collaborators

• Rgene Corporation: lead
• American BriVision Corporation: collaborator

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Gi-Ming Lai, M.D.

  Taipei Municipal Wanfang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank C. Liu

CONTACT

+886-2-87518701; liu3763@bioliteinc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study Objectives Part I To determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy in a 28-day schedule. Part II To assess the efficacy and safety of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy at the recommended dose.

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 4, 2017
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share