Testing the Addition of Anti-Cancer Drug, ZEN003694 (ZEN-3694) and PD-1 Inhibitor (Pembrolizumab), to Standard Chemotherapy (Nab-Paclitaxel) Treatment in Patients With Advanced Triple-Negative Breast Cancer

Conditions

• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Locally Advanced Triple-Negative Breast Carcinoma
• Metastatic Triple-Negative Breast Carcinoma
• Unresectable Triple-Negative Breast Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BET Bromodomain Inhibitor ZEN-3694 — DRUG
  Given PO
• Biopsy Procedure — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Computed Tomography — PROCEDURE
  Undergo CT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Nab-paclitaxel — DRUG
  Given IV
• Pembrolizumab — BIOLOGICAL
  Given IV

Study Details

This phase Ib trial tests the safety and tolerability of ZEN003694 in combination with an immunotherapy drug called pembrolizumab and the usual chemotherapy approach with nab-paclitaxel for the treatment of patients with triple negative-negative breast cancer that has spread to other parts of the body (advanced). Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Immunotherapy with monoclonal antibodies, such as pembrolizumab may help the body's immune system attach the cancer and may interfere with the ability of tumor cells to grow and spread. ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that over produce BET protein. Combination therapy with ZEN003694 pembrolizumab immunotherapy and nab-paclitaxel chemotherapy may help shrink or stabilize cancer for longer than chemotherapy alone.

Key Dates

Start date

May 18, 2023

Status verified

Apr 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

57 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation (ZEN003694, nab-paclitaxel, pembrolizumab)
  Patients receive ZEN003694 PO QD on days 1-21, nab-paclitaxel IV over 30 minutes on day 1, 8, and 15, and pembrolizumab IV over 30 minutes every 21 days of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity with a maximum of 35 doses of pembrolizumab administered. Patients also undergo CT or MRI scan and collection of blood samples throughout the trial.
• Experimental: Dose Expansion (ZEN003694, nab-paclitaxel, pembrolizumab)
  Patients receive ZEN003694 PO QD on days 1-7 prior to combination therapy. Patients then receive ZEN003694 PO QD on days 1-21, nab-paclitaxel IV over 30 minutes on days 1, 8, and 15, and pembrolizumab IV over 30 minutes every 21 days of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity with a maximum of 35 doses of pembrolizumab administered. Patients also undergo biopsies on study, and CT or MRI scans and collection of blood samples throughout the trial.

Primary Outcome Measure

Maximum tolerated dose (MTD) of ZEN003694 (ZEN-3694) used in combination with pembrolizumab and nab-paclitaxel [ Time Frame: Up to 28 days from start of treatment ]

Locations (6)

Find similar trials in Boston, MA

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