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The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505.
This is a study of SGR-1505, an oral inhibitor of MALT1, in subjects with relapsed/refractory (R/R) B-cell lymphomas to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505. Exploratory cohorts will evaluate additional PK, PD, preliminary anti-tumor activity, and safety to establish the SGR-1505 RD. A planned amendment will evaluate SGR-1505 in combination with other anti-cancer agents, such as BTK and BCL-2 inhibitors, in patients with specific B-cell malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Up to 9 dose levels in total will be evaluated across two dosing schedules. Eligible patients will be assigned to a dose level cohort according to an accelerated titration design that will transition to a traditional 3+3 dose escalation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGR-1505 | Drug | SGR-1505 will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation. | Throughout the study, up to 2 years. | |
| Nature and number of incidences of dose limiting toxicity (DLT). | A DLT is an AE that requires treatment interruption. | The first 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| SGR-1505 Maximal Plasma Concentration (Cmax) | Concentrations of SGR-1505 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the maximal plasma concentration (Cmax). | Through study completion, up to 2 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Physician | Contact | +1 (503)-922-0158 | sdgr-trials-group@schrodinger.com |
| Name | Affiliation | Role |
|---|---|---|
| Frank G Basile, M.D. | Schrodinger Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Health - MD Anderson Cancer Center | Recruiting | Gilbert | Arizona | 85234 | United States |
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| SGR-1505 Time to Maximal Plasma Concentration (tmax) |
Concentrations of SGR-1505 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the time to maximal plasma concentration (tmax). |
| Through study completion, up to 2 years. |
| SGR-1505 Area Under the Concentration Versus Time Curve (AUC) | Concentrations of SGR-1505 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the area under the concentration versus time curve (AUC). | Through study completion, up to 2 years. |
| Objective Response Rate (ORR) | Number of patients who have an objective response per response criteria other than stable disease (SD) or progressive disease (PD) to treatment. | Throughout the study, up to 2 years. |
| Duration of Response (DOR) | The time from response CR/PR until relapse or death from any cause. | Throughout the study, up to 2 years. |
| Disease Control Rate | PR, CR, and SD for 2 post-baseline disease assessments at least 6 weeks apart. | Throughout the study, up to 2 years. |
| Christiana Care Hospital - Helen F Graham Cancer Center | Recruiting | Newark | Delaware | 19713 | United States |
|
| Napa Research | Recruiting | Pompano Beach | Florida | 99064 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| Regional Cancer Care Associates | Recruiting | Hackensack | New Jersey | 07601 | United States |
|
| Roswell Park Comprehensive Cancer Center | Recruiting | Buffalo | New York | 14203 | United States |
| Weill Cornell | Recruiting | New York | New York | 10065 | United States |
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
| Gabrail Cancer & Research Center | Recruiting | Canton | Ohio | 44718 | United States |
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| The Ohio State University - The James Cancer Hospital | Recruiting | Columbus | Ohio | 43210 | United States |
|
| Oregon Health and Science University - Knight Cancer Institute | Recruiting | Portland | Oregon | 97329 | United States |
|
| Rhode Island Hospital | Recruiting | Providence | Rhode Island | 02903 | United States |
|
| University of Texas Southwestern | Recruiting | Dallas | Texas | 75390 | United States |
| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
|
| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
|
| AP-HP Hôpital Henri-Mondor | Recruiting | Créteil | France |
| Institut Gustave Roussy | Recruiting | Villejuif | France |
| Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Presidio Ospedaliero SS Antonio e Biagio e Cesare Arrigo, Ospedale Civile | Recruiting | Alessandria | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | Italy |
| IRCCS Ospedale San Raffaele | Recruiting | Milan | Italy |
| AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette | Recruiting | Torino | Italy |
| Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma | Recruiting | Verona | Italy |
| Institute of Oncology, ARENSIA Exploratory Medicine | Recruiting | Chisinau | Moldova |
|
| Uniwersyteckie Centrum Kliniczne, Osrodek Badan Klinicznych Wczesnych Faz | Recruiting | Gdansk | Poland |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Recruiting | Lodz | Poland |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie | Recruiting | Warsaw | Poland |
| ARENSIA Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti | Recruiting | Bucharest | Romania |
| ARENSIA Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca | Recruiting | Cluj-Napoca | Romania |
| Institut Catala d'Oncologia - L'Hospitalet | Recruiting | Barcelona | Spain |
| Hospital Universitario Quironsalud Madrid | Recruiting | Madrid | Spain |
| START Madrid - CIOCC | Recruiting | Madrid | Spain |
| START Madrid - Hospital Fundacion Jimenez Diaz | Recruiting | Madrid | Spain |
| Clinica Universidad de Navarra - Pamplona | Recruiting | Pamplona | Spain |
| Hospital Clinico Universitario de Salamanca | Recruiting | Salamanca | Spain |
| ARENSIA Research Clinic at Harmony Health Clinic | Recruiting | Kyiv | Ukraine |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008258 | Waldenstrom Macroglobulinemia |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008224 | Lymphoma, Follicular |
| D046248 | Pyloric Stenosis, Hypertrophic |
| D002051 | Burkitt Lymphoma |
| D000069293 | Plasmablastic Lymphoma |
| D054685 | Lymphoma, Primary Effusion |
| D020522 | Lymphoma, Mantle-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D016393 | Lymphoma, B-Cell |
| D011707 | Pyloric Stenosis |
| D017219 | Gastric Outlet Obstruction |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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