Clinical Trials in Spain / NCT05544019
Recruiting
Phase 1
Study of SGR-1505 in Mature B-Cell Neoplasms
NCT05544019 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Mature B-Cell NeoplasmNon Hodgkin LymphomaDLBCLWaldenstrom MacroglobulinemiaMALT LymphomaFollicular LymphomaPediatric-Type Follicular LymphomaIRF4 Gene RearrangementEBV-Positive DLBCL, NosBurkitt LymphomaPlasmablastic LymphomaHigh-grade B-cell LymphomaPrimary Cutaneous Follicle Center LymphomaPrimary Effusion LymphomaMantle Cell LymphomaDLBCL Germinal Center B-Cell TypePrimary Mediastinal Large B Cell LymphomaT-Cell/Histiocyte Rich LymphomaALK-Positive Large B-Cell LymphomaPrimary Cutaneous Diffuse Large B-Cell LymphomaSplenic Marginal Zone LymphomaChronic Lymphocytic LeukemiaNodal Marginal Zone LymphomaHHV8-Positive DLBCL, NosLymphoplasmacytic LymphomaDuodenal-Type Follicular Lymphoma
Investigational drug(s) / intervention(s)
SGR-1505
SGR-1505: SGR-1505 will be administered orally.
Study summary
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.
Eligibility
Inclusion Criteria:
* Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.
* Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy ≥ 12 weeks.
Exclusion Criteria:
* The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit).
* Subject has previous invasive malignancy in the last 2 years.
* Subject has a known allergy to SGR-1505 or excipients of SGR-1505.
* Subject has symptomatic or active CNS involvement of disease.
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.
Primary outcome measure(s)
- 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). — The first 21 days.
A DLT is an AE that requires treatment interruption.
Trial sites (36)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner Health - MD Anderson Cancer Center | Gilbert | Arizona | Recruiting |
| Christiana Care Hospital - Helen F Graham Cancer Center | Newark | Delaware | Recruiting |
| Napa Research | Pompano Beach | Florida | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | Recruiting |
| Regional Cancer Care Associates | Hackensack | New Jersey | Recruiting |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | Recruiting |
| Weill Cornell | New York | New York | Recruiting |
| Montefiore Medical Center | The Bronx | New York | Recruiting |
| Duke University | Durham | North Carolina | Recruiting |
| Gabrail Cancer & Research Center | Canton | Ohio | Recruiting |
| The Ohio State University - The James Cancer Hospital | Columbus | Ohio | Recruiting |
| Oregon Health and Science University - Knight Cancer Institute | Portland | Oregon | Recruiting |
| Rhode Island Hospital | Providence | Rhode Island | Recruiting |
| University of Texas Southwestern | Dallas | Texas | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
| AP-HP Hôpital Henri-Mondor | Créteil | France | Recruiting |
| Institut Gustave Roussy | Villejuif | France | Recruiting |
| Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Presidio Ospedaliero SS Antonio e Biagio e Cesare Arrigo, Ospedale Civile | Alessandria | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy | Recruiting |
| IRCCS Ospedale San Raffaele | Milan | Italy | Recruiting |
| AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette | Torino | Italy | Recruiting |
| Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma | Verona | Italy | Recruiting |
| Institute of Oncology, ARENSIA Exploratory Medicine | Chisinau | Moldova | Recruiting |
| Uniwersyteckie Centrum Kliniczne, Osrodek Badan Klinicznych Wczesnych Faz | Gdansk | Poland | Recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Lodz | Poland | Recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie | Warsaw | Poland | Recruiting |
| ARENSIA Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti | Bucharest | Romania | Recruiting |
| ARENSIA Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca | Cluj-Napoca | Romania | Recruiting |
| Institut Catala d'Oncologia - L'Hospitalet | Barcelona | Spain | Recruiting |
| Hospital Universitario Quironsalud Madrid | Madrid | Spain | Recruiting |
| START Madrid - CIOCC | Madrid | Spain | Recruiting |
| START Madrid - Hospital Fundacion Jimenez Diaz | Madrid | Spain | Recruiting |
| Clinica Universidad de Navarra - Pamplona | Pamplona | Spain | Recruiting |
| Hospital Clinico Universitario de Salamanca | Salamanca | Spain | Recruiting |
| ARENSIA Research Clinic at Harmony Health Clinic | Kyiv | Ukraine | Recruiting |
Other trials for the same condition
A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05544019 on ClinicalTrials.gov ↗ ← All trials in Spain