^
    11d
    A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=115, Terminated, Zenith Epigenetics | Trial completion date: Dec 2024 --> Mar 2024 | Active, not recruiting --> Terminated; Parts 1 and 2 and Expansion Cohort C were completed. Expansion Cohorts A and B were discontinued based on results from an interim futility analysis and not due to safety concerns.
    Trial completion date • Trial termination • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Talzenna (talazoparib) • ZEN-3694
    19d
    ZEN-3694, Enzalutamide, and Pembrolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=54, Recruiting, Rahul Aggarwal | Trial completion date: Dec 2025 --> Apr 2027 | Trial primary completion date: Dec 2025 --> Apr 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • RB1 (RB Transcriptional Corepressor 1)
    |
    RB1 deletion • RB deletion
    |
    Keytruda (pembrolizumab) • Xtandi (enzalutamide capsule) • ZEN-3694
    27d
    Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol (clinicaltrials.gov)
    P1/2, N=40, Enrolling by invitation, Zenith Epigenetics | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    Xtandi (enzalutamide capsule) • ZEN-3694
    27d
    ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=200, Recruiting, Zenith Epigenetics | Phase classification: P2b --> P2 | Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: Mar 2024 --> Dec 2024
    Phase classification • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Xtandi (enzalutamide capsule) • abiraterone acetate • ZEN-3694
    27d
    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, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension • Metastases
    |
    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
    2ms
    Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer (clinicaltrials.gov)
    P1, N=42, Recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • PGR (Progesterone receptor) • NRAS (Neuroblastoma RAS viral oncogene homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog) • NF1 (Neurofibromin 1)
    |
    BRAF mutation • HER-2 amplification • NF1 mutation • HRAS mutation • BRAF fusion
    |
    Mektovi (binimetinib) • ZEN-3694
    2ms
    Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer (clinicaltrials.gov)
    P1, N=30, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | N=22 --> 30 | Trial completion date: Jun 2024 --> Jun 2025 | Initiation date: Feb 2024 --> Nov 2024 | Trial primary completion date: Jun 2024 --> Jun 2025
    Enrollment open • Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E
    |
    Erbitux (cetuximab) • Braftovi (encorafenib) • ZEN-3694
    3ms
    NRG-GY031: Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer (clinicaltrials.gov)
    P1, N=60, Recruiting, National Cancer Institute (NCI) | Initiation date: May 2024 --> Dec 2023
    Trial initiation date
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MSI (Microsatellite instability) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • ARID1A (AT-rich interaction domain 1A) • MUC16 (Mucin 16, Cell Surface Associated) • HEXIM1 (HEXIM P-TEFb Complex Subunit 1)
    |
    MSI-H/dMMR
    |
    ZEN-3694 • tuvusertib (M1774)
    3ms
    ZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors (clinicaltrials.gov)
    P1, N=26, Recruiting, Haider Mahdi | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BRCA (Breast cancer early onset)
    |
    Zejula (niraparib) • ZEN-3694
    3ms
    A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=115, Active, not recruiting, Zenith Epigenetics | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Talzenna (talazoparib) • ZEN-3694
    5ms
    Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors (clinicaltrials.gov)
    P1, N=66, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2024 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Jan 2026
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • ZEN-3694 • ABP 206 (nivolumab biosimilar)
    5ms
    ZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors (clinicaltrials.gov)
    P1, N=26, Not yet recruiting, Haider Mahdi
    New P1 trial
    |
    BRCA (Breast cancer early onset)
    |
    Zejula (niraparib) • ZEN-3694
    5ms
    Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer (clinicaltrials.gov)
    P1, N=60, Recruiting, National Cancer Institute (NCI) | Phase classification: P1b --> P1
    Phase classification
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MSI (Microsatellite instability) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • ARID1A (AT-rich interaction domain 1A) • MUC16 (Mucin 16, Cell Surface Associated) • HEXIM1 (HEXIM P-TEFb Complex Subunit 1)
    |
    MSI-H/dMMR
    |
    ZEN-3694 • tuvusertib (M1774)
    5ms
    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 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    BRD4 (Bromodomain Containing 4) • NUTM1 (NUT Midline Carcinoma Family Member 1)
    |
    cisplatin • etoposide IV • ZEN-3694
    5ms
    Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers (clinicaltrials.gov)
    P1, N=30, Recruiting, National Cancer Institute (NCI) | Initiation date: Apr 2024 --> Nov 2023
    Trial initiation date • Combination therapy • Metastases
    |
    capecitabine • ZEN-3694
    6ms
    ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer (clinicaltrials.gov)
    P2, N=33, Recruiting, Haider Mahdi | Trial completion date: Nov 2027 --> Mar 2031 | Trial primary completion date: Nov 2025 --> Dec 2029
    Trial completion date • Trial primary completion date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    Talzenna (talazoparib) • 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) | Phase classification: P1b --> P1
    Phase classification
    |
    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
    6ms
    A Study of ZEN003694 in People With Squamous Cell Lung Cancer (clinicaltrials.gov)
    P2; Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date
    |
    NSD3 (Nuclear Receptor Binding SET Domain Protein 3)
    |
    MSK-IMPACT • MSK-ACCESS
    |
    ZEN-3694
    7ms
    Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer (clinicaltrials.gov)
    P1, N=22, Not yet recruiting, National Cancer Institute (NCI)
    New P1 trial • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E
    |
    Erbitux (cetuximab) • Braftovi (encorafenib) • ZEN-3694
    8ms
    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)
    P1b, N=57, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2027 --> Dec 2025
    Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD31 (Platelet and endothelial cell adhesion molecule 1) • PECAM1 (Platelet And Endothelial Cell Adhesion Molecule 1)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • albumin-bound paclitaxel • ZEN-3694
    8ms
    A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer (clinicaltrials.gov)
    P2b, N=179, Recruiting, Zenith Epigenetics | Trial completion date: May 2024 --> Sep 2024 | Trial primary completion date: Nov 2023 --> Mar 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Talzenna (talazoparib) • ZEN-3694
    8ms
    NRG-GY031: Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer (clinicaltrials.gov)
    P1b, N=60, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Aug 2023 --> May 2024
    Enrollment open • Trial initiation date
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MSI (Microsatellite instability) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • ARID1A (AT-rich interaction domain 1A) • MUC16 (Mucin 16, Cell Surface Associated) • HEXIM1 (HEXIM P-TEFb Complex Subunit 1)
    |
    MSI-H/dMMR
    |
    ZEN-3694 • tuvusertib (M1774)
    10ms
    Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers (clinicaltrials.gov)
    P1, N=30, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Trial completion date: Jun 2025 --> Jun 2026 | Initiation date: Apr 2023 --> Apr 2024 | Trial primary completion date: Jun 2025 --> Jun 2026
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy • Metastases
    |
    TNFRSF10B (TNF Receptor Superfamily Member 10b)
    |
    capecitabine • ZEN-3694
    10ms
    Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer (clinicaltrials.gov)
    P1b, N=60, Not yet recruiting, National Cancer Institute (NCI)
    New P1 trial
    |
    MSI (Microsatellite instability) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • ARID1A (AT-rich interaction domain 1A)
    |
    MSI-H/dMMR • MYC expression
    |
    ZEN-3694 • tuvusertib (M1774)
    10ms
    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)
    P1b, N=57, Recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2025 --> Jun 2027 | Trial primary completion date: Sep 2025 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD31 (Platelet and endothelial cell adhesion molecule 1) • PECAM1 (Platelet And Endothelial Cell Adhesion Molecule 1)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • albumin-bound paclitaxel • ZEN-3694
    1year
    Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, National Cancer Institute (NCI)
    New P1 trial • Combination therapy • Metastases
    |
    TNFRSF10B (TNF Receptor Superfamily Member 10b)
    |
    capecitabine • ZEN-3694
    1year
    Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer (clinicaltrials.gov)
    P1, N=42, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • PGR (Progesterone receptor) • NRAS (Neuroblastoma RAS viral oncogene homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog) • NF1 (Neurofibromin 1)
    |
    BRAF mutation • HER-2 amplification • NF1 mutation • HRAS mutation • BRAF fusion
    |
    Mektovi (binimetinib) • ZEN-3694
    1year
    Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer (clinicaltrials.gov)
    P1, N=42, Suspended, National Cancer Institute (NCI) | N=18 --> 42
    Enrollment change • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • PGR (Progesterone receptor) • NRAS (Neuroblastoma RAS viral oncogene homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog) • NF1 (Neurofibromin 1)
    |
    BRAF mutation • HER-2 amplification • NF1 mutation • HRAS mutation • BRAF fusion
    |
    Mektovi (binimetinib) • ZEN-3694
    over1year
    Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors (clinicaltrials.gov)
    P1; Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2023 --> Jan 2024
    Trial completion date • Trial primary completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • CCNE1 (Cyclin E1) • IFNG (Interferon, gamma) • BRD4 (Bromodomain Containing 4)
    |
    PD-L1 expression • MYC expression
    |
    TruSight Oncology 500 Assay
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • ZEN-3694
    over1year
    A Study of ZEN003694 in People With Squamous Cell Lung Cancer (clinicaltrials.gov)
    P2; N=25; Recruiting; Sponsor:Memorial Sloan Kettering Cancer Center
    New P2 trial
    |
    NSD3 (Nuclear Receptor Binding SET Domain Protein 3)
    |
    MSK-IMPACT • MSK-ACCESS
    |
    ZEN-3694
    over1year
    Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors (clinicaltrials.gov)
    P1; N=36 --> 66
    Enrollment change • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • CCNE1 (Cyclin E1) • IFNG (Interferon, gamma) • BRD4 (Bromodomain Containing 4)
    |
    PD-L1 expression • MYC expression
    |
    TruSight Oncology 500 Assay
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • ZEN-3694
    over1year
    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)
    P1b, N=45, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Trial completion date: Feb 2023 --> Sep 2025 | Trial primary completion date: Feb 2023 --> Sep 2025
    Enrollment open • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD31 (Platelet and endothelial cell adhesion molecule 1) • PECAM1 (Platelet And Endothelial Cell Adhesion Molecule 1)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • albumin-bound paclitaxel • ZEN-3694
    over1year
    Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer (clinicaltrials.gov)
    P1, N=18, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • PGR (Progesterone receptor) • NRAS (Neuroblastoma RAS viral oncogene homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog) • NF1 (Neurofibromin 1)
    |
    BRAF mutation • HER-2 amplification • NF1 mutation • HRAS mutation • BRAF fusion
    |
    Mektovi (binimetinib) • ZEN-3694
    over1year
    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 and Other Solid Tumors (clinicaltrials.gov)
    P1, N=30, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension • Combination therapy
    |
    NUTM1 (NUT Midline Carcinoma Family Member 1)
    |
    Verzenio (abemaciclib) • ZEN-3694
    over1year
    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 and Other Solid Tumors (clinicaltrials.gov)
    P1, N=30, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting
    Enrollment open • Combination therapy
    |
    NUTM1 (NUT Midline Carcinoma Family Member 1)
    |
    Verzenio (abemaciclib) • ZEN-3694
    over1year
    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 and Other Solid Tumors (clinicaltrials.gov)
    P1, N=30, Suspended, National Cancer Institute (NCI) | Not yet recruiting --> Suspended
    Trial suspension • Combination therapy
    |
    NUTM1 (NUT Midline Carcinoma Family Member 1)
    |
    Verzenio (abemaciclib) • ZEN-3694
    over1year
    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) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    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 • FANCA mutation • RAD51D mutation • BARD1 mutation
    |
    Talzenna (talazoparib) • ZEN-3694
    almost2years
    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 and Other Solid Tumors (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, National Cancer Institute (NCI) | N=18 --> 30
    Enrollment change • Combination therapy
    |
    NUTM1 (NUT Midline Carcinoma Family Member 1)
    |
    Verzenio (abemaciclib) • ZEN-3694
    almost2years
    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, Not yet recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial primary 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 • FANCA mutation • RAD51D mutation • BARD1 mutation
    |
    Talzenna (talazoparib) • ZEN-3694
    almost2years
    A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer (clinicaltrials.gov)
    P2b, N=179, Recruiting, Zenith Epigenetics | Active, not recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Talzenna (talazoparib) • ZEN-3694
    almost2years
    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)
    P1b, N=45, Not yet recruiting, National Cancer Institute (NCI)
    New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD31 (Platelet and endothelial cell adhesion molecule 1) • PECAM1 (Platelet And Endothelial Cell Adhesion Molecule 1)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • albumin-bound paclitaxel • ZEN-3694
    almost2years
    A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer (clinicaltrials.gov)
    P2b, N=179, Active, not recruiting, Zenith Epigenetics | Phase classification: P2 --> P2b | N=49 --> 179 | Trial completion date: Jan 2024 --> May 2024
    Phase classification • Enrollment change • Trial completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Talzenna (talazoparib) • ZEN-3694