^
    7d
    Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tumors, The ComBET Trial (clinicaltrials.gov)
    P2, N=88, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2026 --> Dec 2027
    Trial completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • RAD51 (RAD51 Homolog A) • FANCA (FA Complementation Group A) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • BARD1 (BRCA1 Associated RING Domain 1)
    |
    KRAS mutation • BRCA2 mutation • BRCA1 mutation • KRAS G12C • KRAS G12 • BRIP1 mutation • RAD51C mutation • RAD51D mutation • BARD1 mutation
    |
    Talzenna (talazoparib) • ZEN-3694
    27d
    A Study of ZEN003694 in People With Squamous Cell Lung Cancer (clinicaltrials.gov)
    P2, N=13, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2026 --> Nov 2027 | Trial primary completion date: Nov 2026 --> Nov 2027
    Trial completion date • Trial primary completion date
    |
    NSD3 (Nuclear Receptor Binding SET Domain Protein 3)
    |
    ZEN-3694
    1m
    Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors (clinicaltrials.gov)
    P1, N=66, Suspended, National Cancer Institute (NCI) | Trial completion date: Jan 2026 --> Sep 2028 | Recruiting --> Suspended | Trial primary completion date: Jan 2026 --> Sep 2028
    Trial completion date • Trial suspension • Trial primary completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • ZEN-3694 • ABP 206 (nivolumab biosimilar)
    3ms
    Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma (clinicaltrials.gov)
    P1/2, N=36, Recruiting, National Cancer Institute (NCI) | Phase classification: P1 --> P1/2
    Phase classification
    |
    BRD4 (Bromodomain Containing 4) • NUTM1 (NUT Midline Carcinoma Family Member 1)
    |
    cisplatin • carboplatin • paclitaxel • etoposide IV • ZEN-3694
    3ms
    Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors (clinicaltrials.gov)
    P1/2, N=49, Recruiting, National Cancer Institute (NCI) | N=30 --> 49
    Enrollment change
    |
    Jingzhuda (entinostat) • ZEN-3694
    4ms
    Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma (clinicaltrials.gov)
    P1, N=36, Recruiting, National Cancer Institute (NCI) | Phase classification: P1/2 --> P1 | N=55 --> 36
    Phase classification • Enrollment change
    |
    BRD4 (Bromodomain Containing 4) • NUTM1 (NUT Midline Carcinoma Family Member 1)
    |
    cisplatin • carboplatin • paclitaxel • etoposide IV • ZEN-3694
    6ms
    A Study of ZEN003694 in People With Squamous Cell Lung Cancer (clinicaltrials.gov)
    P2, N=13, Recruiting, Memorial Sloan Kettering Cancer Center | Trial primary completion date: Nov 2025 --> Nov 2026 | N=25 --> 13 | Trial completion date: Nov 2025 --> Nov 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    NSD3 (Nuclear Receptor Binding SET Domain Protein 3)
    |
    MSK-IMPACT • MSK-ACCESS
    |
    ZEN-3694
    6ms
    BET bromodomain inhibition reverses CDK4/6 inhibitor resistance in estrogen receptor-positive breast cancer via induction of miR-34a-5p. (PubMed, Clin Cancer Res)
    Our findings highlight BET inhibition or application of miR-34a-5p mimics as promising strategies to reverse CDK4/6 inhibitor resistance in a subset of ER+ breast cancers.
    Journal • IO biomarker
    |
    ER (Estrogen receptor) • BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • MIR34A (MicroRNA 34a-5p) • BRD4 (Bromodomain Containing 4)
    |
    ER positive
    |
    Ibrance (palbociclib) • JQ-1 • ZEN-3694
    6ms
    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 (clinicaltrials.gov)
    P1, N=57, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Mar 2027 | Trial primary completion date: Dec 2025 --> Mar 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • albumin-bound paclitaxel • ZEN-3694
    7ms
    The COSMYC Trial (COmbined Suppression of MYC) (clinicaltrials.gov)
    P2, N=50, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Xtandi (enzalutamide) • Eligard (leuprolide acetate) • triptorelin • goserelin acetate • ZEN-3694 • Firmagon (degarelix) • Orgovyx (relugolix)
    7ms
    NCI-2022-04099: Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors (clinicaltrials.gov)
    P1, N=45, Recruiting, National Cancer Institute (NCI) | N=30 --> 45
    Enrollment change
    |
    NUTM1 (NUT Midline Carcinoma Family Member 1)
    |
    Verzenio (abemaciclib) • ZEN-3694
    8ms
    Testing the Safety and Efficacy of the Addition of A New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Etoposide and Cisplatin) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma (clinicaltrials.gov)
    P1/2, N=55, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Dec 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    BRD4 (Bromodomain Containing 4) • NUTM1 (NUT Midline Carcinoma Family Member 1)
    |
    cisplatin • etoposide IV • ZEN-3694