A Phase 1b Trial of ZEN003694 (ZEN-3694) With Pembrolizumab and Nab-Paclitaxel in Patients With Metastatic Triple-Negative Breast Cancer

Official Summary

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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 57 participants

Interventions

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

Primary Outcomes

• Maximum tolerated dose (MTD) of ZEN003694 (ZEN-3694) used in combination with pembrolizumab and nab-paclitaxel (Up to 28 days from start of treatment)
• Recommended phase 2 dose (RP2D) of ZEN003694 (ZEN-3694) used in combination with pembrolizumab and nab-paclitaxel (Up to 28 days from start of treatment)
• Incidence of adverse events (Up to 3 years from treatment start date)

Secondary Outcomes

• Pharmacokinetics profile of the combination of ZEN003694 (ZEN-3694), pembrolizumab and nab-paclitaxel (Pre-dose & 2 hours (h) post-dose on cycle 0 day 1 (C0D1), C2D15, C4D1, & C6D8; pre-dose & 0.5h post-dose on C1D1; pre-dose & 0.5, 1, 2, 4, 6, 8 & 24h post-dose on C1D15)
• Recommended phase 2 dose (RP2D) (Up to 3 years)
• Overall response rate (From start of the treatment until disease progression/ recurrence, or for up to 3 years)
• PFS (From the time of study enrollment until the identification of disease progression or death, or for up to 3 years)
• Overall survival (From the time of study enrollment until death due to any cause, or for up to 3 years)

Trial Locations

• Boston Medical Center, Boston, Massachusetts, United States
• Dana-Farber Cancer Institute, Boston, Massachusetts, United States
• NYU Langone Hospital - Long Island, Mineola, New York, United States
• Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
• Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
• Vanderbilt Breast Center at One Hundred Oaks, Nashville, Tennessee, United States

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