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Life sciences · Phase 1 Trial
ClinicalTrials.gov · September 22, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT05422794). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 57 participants (ESTIMATED). 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. Interventions: DRUG: BET Bromodomain Inhibitor ZEN-3694; PROCEDURE: Biopsy Procedure; PROCEDURE: Biospecimen Collection; PROCEDURE: Computed Tomography; PROCEDURE: Magnetic Resonance Imaging; DRUG: Nab-paclitaxel; BIOLOGICAL: Pembrolizumab. Primary outcome measures: 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. Brief 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.