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This study is testing a new medicine, SNV1521, for people with advanced cancers. The researchers want to find out if SNV1521 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the most effective and safe one. They are also investigating whether it can be combined with other cancer therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy Dose Escalation | Experimental |
| |
| Monotherapy Dose Expansion | Experimental |
| |
| Combination Dose Escalation | Experimental |
| |
| Dose Expansion for Metastatic Castration Resistant Prostate Cancer | Experimental |
| |
| Dose Expansion for Pancreatic Ductal Adenocarcinoma | Experimental |
| |
| Dose Expansion for Solid Tumors with Brain Metastases | Experimental |
| |
| Dose Expansion for Breast Cancer | Experimental |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNV1521 | Drug | SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of SNV1521 | Treatment emergent adverse events (TEAEs) | From first dose through last dose (up to 13 months) |
| Tolerability of SNV1521 | Incidence and frequency of dose-limiting toxicities (DLTs) (Dose-escalation arm only) | DLTs: From first dose through completion of first cycle (28 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Casper | Contact | 443-764-9527 | rcasper@synnovationtx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smilow Cancer Hospital at Yale New Haven | Recruiting | New Haven | Connecticut | 06511 | United States | |
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| Dose Expansion for Ovarian, Epithelial, Fallopian Tube, or Primary Peritoneal Cancer |
| Experimental |
|
| Combination 1 Dose Expansion for mCRPC or mCSPC | Experimental |
|
| Combination 2 Dose Expansion for mCRPC or mCSPC | Experimental |
|
| DB-1310 | Drug | DB-1310 is given as an infusion. Dose and frequency are dependent upon treatment arm. |
|
| Abiraterone | Drug | Abiraterone is taken orally. Dose and frequency are per approved prescribing instructions. |
|
| Darolutamide | Drug | Darolutamide is taken orally. Dose and frequency are per approved prescribing instructions. |
|
| Thomas Jefferson University |
| Recruiting |
| Philadelphia |
| Pennsylvania |
| 19144 |
| United States |
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
| The University of Texas M.D. Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| START Center for Cancer Care | Recruiting | West Valley City | Utah | 84119 | United States |
| Scientia Clinical Research | Recruiting | Randwick | New South Wales | 2031 | Australia |
| Princess Alexandra Hospital | Recruiting | Woolloongabba | Queensland | 4102 | Australia |
| Monash Health | Recruiting | Clayton | Victoria | 3168 | Australia |
| The Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
| Linear Clinical Research | Recruiting | Crawley | Western Australia | 6009 | Australia |
| The Institut Jules Bordet | Recruiting | Brussels | 1070 | Belgium |
|
| University Center for Clinical Research Antwerp (UNICCRA) | Recruiting | Edegem | 2650 | Belgium |
|
| AZ Maria Middelares | Recruiting | Ghent | 9000 | Belgium |
|
| AZ Groeninge | Recruiting | Kortrijk | 8500 | Belgium |
|
| Arthur J.E. Child Comprehensive Cancer Centre | Recruiting | Calgary | Alberta | T2N 5G2 | Canada |
| Princess Margaret Hospital | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Institut Bergonie | Recruiting | Bordeaux | 33076 | France |
| UNICANCER - Centre Leon-Berard (CLB) | Recruiting | Lyon | 69008 | France |
| Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| Istituto Clinico Humanitas | Recruiting | Milan | 20089 | Italy |
| Istituto Europeo di Oncologia (IEO) (European Institute of Oncology) | Recruiting | Milan | 20141 | Italy |
| NEXT Oncology - Barcelona | Recruiting | Barcelona | 08023 | Spain |
| Vall d'Hebron University Hospital | Recruiting | Barcelona | 08035 | Spain |
| The START Center for Cancer Care - Madrid - CIOCC - Hospital Universitario Madrid Sanchinarro | Recruiting | Madrid | 28050 | Spain |
| NEXT Oncology - Hospital Quironsalud Madrid | Recruiting | Madrid | 28223 | Spain |
| ID | Term |
|---|---|
| C089740 | abiraterone |
| C000607739 | darolutamide |
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