Trials / Recruiting
RecruitingNCT05544019
Study of SGR-1505 in Mature B-Cell Neoplasms
A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 98 (estimated)
- Sponsor
- Schrödinger, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SGR-1505 | SGR-1505 will be administered orally. |
Timeline
- Start date
- 2023-04-10
- Primary completion
- 2027-11-01
- Completion
- 2027-11-01
- First posted
- 2022-09-16
- Last updated
- 2026-02-13
Locations
36 sites across 8 countries: United States, France, Italy, Moldova, Poland, Romania, Spain, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05544019. Inclusion in this directory is not an endorsement.