^
1m
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 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
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
2ms
ZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors (clinicaltrials.gov)
P1, N=0, Withdrawn, Haider Mahdi | N=26 --> 0 | Recruiting --> Withdrawn
Enrollment change • Trial withdrawal • Metastases
|
BRCA (Breast cancer early onset)
|
Zejula (niraparib) • ZEN-3694
4ms
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)
|
Mektovi (binimetinib) • ZEN-3694
7ms
Trial initiation date • Combination therapy • Metastases
|
BRAF (B-raf proto-oncogene)
|
Erbitux (cetuximab) • Braftovi (encorafenib) • ZEN-3694
8ms
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
8ms
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) • ZEN-3694
8ms
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) • ZEN-3694
8ms
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) • abiraterone acetate • ZEN-3694
8ms
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
9ms
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
10ms
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
10ms
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)
11ms
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
11ms
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
1year
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)
1year
New P1 trial
|
BRCA (Breast cancer early onset)
|
Zejula (niraparib) • ZEN-3694
1year
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)
1year
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
1year
Trial initiation date • Combination therapy • Metastases
|
capecitabine • ZEN-3694
1year
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
1year
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
1year
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
1year
New P1 trial • Combination therapy • Metastases
|
BRAF (B-raf proto-oncogene)
|
BRAF V600E
|
Erbitux (cetuximab) • Braftovi (encorafenib) • ZEN-3694
1year
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
over1year
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
over1year
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)
over1year
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
over1year
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)
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=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
over1year
New P1 trial • Combination therapy • Metastases
|
TNFRSF10B (TNF Receptor Superfamily Member 10b)
|
capecitabine • ZEN-3694
almost2years
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
almost2years
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
2years
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
2years
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
2years
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
2years
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
2years
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
over2years
Trial suspension • Combination therapy
|
NUTM1 (NUT Midline Carcinoma Family Member 1)
|
Verzenio (abemaciclib) • ZEN-3694
over2years
Enrollment open • Combination therapy
|
NUTM1 (NUT Midline Carcinoma Family Member 1)
|
Verzenio (abemaciclib) • ZEN-3694
over2years
Trial suspension • Combination therapy
|
NUTM1 (NUT Midline Carcinoma Family Member 1)
|
Verzenio (abemaciclib) • ZEN-3694
over2years
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
over2years
Enrollment change • Combination therapy
|
NUTM1 (NUT Midline Carcinoma Family Member 1)
|
Verzenio (abemaciclib) • ZEN-3694