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Recruiting Phase 1

Study of SGR-1505 in Mature B-Cell Neoplasms

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About this study

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.

Condition
Mature B-Cell Neoplasm, Non Hodgkin Lymphoma, DLBCL, Waldenstrom Macroglobulinemia, MALT Lymphoma, Follicular Lymphoma, Pediatric-Type Follicular Lymphoma, IRF4 Gene Rearrangement, EBV-Positive DLBCL, Nos, Burkitt Lymphoma, Plasmablastic Lymphoma, High-grade B-cell Lymphoma, Primary Cutaneous Follicle Center Lymphoma, Primary Effusion Lymphoma, Mantle Cell Lymphoma, DLBCL Germinal Center B-Cell Type, Primary Mediastinal Large B Cell Lymphoma, T-Cell/Histiocyte Rich Lymphoma, ALK-Positive Large B-Cell Lymphoma, Primary Cutaneous Diffuse Large B-Cell Lymphoma, Splenic Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, Nodal Marginal Zone Lymphoma, HHV8-Positive DLBCL, Nos, Lymphoplasmacytic Lymphoma, Duodenal-Type Follicular Lymphoma
Tested
SGR-1505
Sponsor
Schrödinger, Inc.

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 6

  • Minimum age: 18 years
  • Study condition: Mature B-Cell Neoplasm, Non Hodgkin Lymphoma, DLBCL, Waldenstrom Macroglobulinemia, MALT Lymphoma, Follicular Lymphoma, Pediatric-Type Follicular Lymphoma, IRF4 Gene Rearrangement, EBV-Positive DLBCL, Nos, Burkitt Lymphoma, Plasmablastic Lymphoma, High-grade B-cell Lymphoma, Primary Cutaneous Follicle Center Lymphoma, Primary Effusion Lymphoma, Mantle Cell Lymphoma, DLBCL Germinal Center B-Cell Type, Primary Mediastinal Large B Cell Lymphoma, T-Cell/Histiocyte Rich Lymphoma, ALK-Positive Large B-Cell Lymphoma, Primary Cutaneous Diffuse Large B-Cell Lymphoma, Splenic Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, Nodal Marginal Zone Lymphoma, HHV8-Positive DLBCL, Nos, Lymphoplasmacytic Lymphoma, Duodenal-Type Follicular Lymphoma
  • 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 5

  • 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.

Where

36 sites, 36 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

and 30 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.