Study of SGR-1505 in Mature B-Cell Neoplasms

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Schrödinger, Inc.
Study ID
NCT05544019
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SGR-1505 — DRUG
    SGR-1505 will be administered orally.

Study Details

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.

Key Dates

Start date
Apr 10, 2023
Status verified
Feb 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
98 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    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.

Primary Outcome Measure

Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation. [ Time Frame: Throughout the study, up to 2 years. ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Banner Health - MD Anderson Cancer CenterGilbertArizona85234
Bryan Crabtree
[email protected]
480-256-5411
Christiana Care Hospital - Helen F Graham Cancer CenterNewarkDelaware19713
Denise Demaio, BSN, RN
[email protected]
302-623-4639
Napa ResearchPompano BeachFlorida99064
Magda Hernandez
[email protected]
954-773-9890
David Kahn, M.D. (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
[email protected]
617-667-9920
Regional Cancer Care AssociatesHackensackNew Jersey07601
Melanie Gonzales
[email protected]
732-530-8666
Iuliana Shapira, M.D. (PRINCIPAL_INVESTIGATOR)
Roswell Park Comprehensive Cancer CenterBuffaloNew York14203-
Weill CornellNew YorkNew York10065-
Montefiore Medical CenterThe BronxNew York10467-
Duke UniversityDurhamNorth Carolina27710-
Gabrail Cancer & Research CenterCantonOhio44718
Carrie Smith, R.N.
[email protected]
330-492-3345
Nashat Gabrail, M.D. (PRINCIPAL_INVESTIGATOR)
The Ohio State University - The James Cancer HospitalColumbusOhio43210
614-366-5643
Jennifer Woyach, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science University - Knight Cancer InstitutePortlandOregon97329
Knight Clinical Trials
[email protected]
503-494-1080
Rhode Island HospitalProvidenceRhode Island02903
Andrew Schumacher
[email protected]
Adam Olszewski, M.D. (PRINCIPAL_INVESTIGATOR)
University of Texas SouthwesternDallasTexas75390-
Fred Hutchinson Cancer CenterSeattleWashington98109
[email protected]
206-606-2037
Ajay Gopal, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
[email protected]
414-805-8900

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