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

ConditionTriple Negative Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age20-70
SponsorBioLite, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: BLEX 404 Oral LiquidExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
3 weeks (1 cycle)
2

Phase II: Overall response rate (PR + CR)

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

Time frame
12 weeks (4 cycles)

Secondary outcomes

1

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

Overall response rate (PR + CR) after at least 1 cycle of combination use in BLEX 404 + Docetaxel monotherapy.

Time frame
at least 3 weeks (1 cycle)
2

Phase II: Incidence of grade 3/4 hematological toxicity

Rate of grade 3/4 hematological toxicity of each cycle.

Time frame
3 weeks (1 cycle)
3

Quality of Life by EORTC QLQ-C30

Examination of quality of life by EORTC QLQ-C30 questionnaire of each cycle.

Time frame
3 weeks (1 cycle)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioLite, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: