Phase I/II, Evaluate the Safety and Efficacy of BLEX 404 With Docetaxel in Patients With Advanced/Metastatic Triple Negative Breast Cancer.

NCT02802423 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BLI-1401-2-01
• Study Type: interventional
• Target: 44
• 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 Docetaxel monotherapy in a 21-day schedule. The secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with Docetaxel monotherapy.

Conditions

Triple Negative Breast Cancer

Keywords

TNBC; Breast cancer; Triple negative

Outcome Measures

Primary Outcomes (2)

• Phase 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 Docetaxel monotherapy to determine the recommended dose level (RDL).

  3 weeks (1 cycle)

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

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

  12 weeks (4 cycles)

Secondary Outcomes (3)

• Phase II: Overall response rate (PR + CR)(at least 1 cycle)

  at least 3 weeks (1 cycle)

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

  3 weeks (1 cycle)

• Quality of Life by EORTC QLQ-C30

  3 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 Docetaxel monotherapy among 6 patients in the Phase I study.

Drug: BLEX 404 Oral Liquid

Interventions

BLEX 404 Oral Liquid DRUG

BLEX 404 Oral Liquid is administered twice daily during the Docetaxel monotherapy period. The dose of Docetaxel is 75 mg/m2 IV, 21 days a cycle.

BLEX 404 Oral Liquid

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females aged 20 - 70 years old at the time of signing the ICF.
• Patients with histologically or pathologically diagnosed with advanced/metastatic triple negative (ER-, PR-, and HER2-negative) breast cancer.
• ER =\< 10% by immunohistochemistry (IHC) tumor staining;
• PR =\< 10% by IHC tumor staining;
• HER2-negative defined as one of the following: 0 or 1+ by IHC, or 2+ by IHC and fluorescence in situ hybridization (FISH)-negative (ratio \< 2.0).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Adequate hematologic function defined as: absolute neutrophil count (ANC) greater than or equal to 2,000/μL; platelets count greater than or equal to 100,000/μL; hemoglobin must be greater than or equal to 10 g/dL (can be corrected by growth factor or transfusion).
• Adequate hepatic function defined as: serum bilirubin less than or equal to 1.5-fold upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) less than or equal to 3-fold ULN.
• Adequate renal function with: serum creatinine less than or equal to 1.3 mg/dL or calculated creatinine clearance greater than or equal to 60 mL/minute according to the Cockcroft and Gault formula.
• 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), from time of Screening Visit until 30 days after study drug discontinuation.
• Planning to receive Docetaxel monotherapy.
• Willing and able to comply with all aspects of the treatment protocol.
• Provide written informed consent.

You may not qualify if:

• Patient with brain metastasis.
• Patient with autoimmune disease that requires systemic steroids or immunosuppression agents.
• Current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent.
• Patients with following treatment prior to Docetaxel monotherapy: chemotherapy, immunotherapy, or biologic systemic anticancer therapy within 21 days of study entry (42 days for mitomycin and nitrosoureas); prior taxanes; radiation therapy within 28 days (3 months for bone marrow exposure 20%); hormonal therapy within 4 weeks.
• Known history of human immunodeficiency virus (HIV) infection.
• Existing anticancer treatment-related toxicities of Grades greater than or equal to 2 (except for alopecia and neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE v4.03).
• Patients with Grade \> 2 neuropathy.
• Patient has an active infection requiring systemic therapy.
• History of concomitant medical conditions or infectious diseases that, in the opinion of the investigator, would compromise the subject's ability to safely complete the study.
• Clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT/QTc (\[QT interval/corrected QT interval\].
• Ascertained hypersensitivity to any component of investigational product used in the study.
• Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily BLEX 404 Oral Liquid treatment.
• Judged to be not applicable to this study by investigator such as difficulty of follow-up observation, psychiatric disorder, with any other serious diseases/medical history.

Sponsors & Collaborators

• BioLite, Inc.: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Richard King, Ph.D.

  American BriVision Corporation

  STUDY DIRECTOR

Central Study Contacts

Hsien-Ming Wu, Master

CONTACT

886-3-657-9631; sonnywu@bioliteinc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 16, 2016
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): August 28, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04