Clinical trial · Interventional
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
NCT05544019CI-TRIAL-00103236recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (26)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALK-Positive Large B-Cell Lymphoma | ALK-Positive Large B-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Burkitt Lymphoma | Burkitt Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| DLBCL | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| DLBCL Germinal Center B-Cell Type | Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type | ALIAS | 0.90 |
| Duodenal-Type Follicular Lymphoma | Duodenal-Type Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| EBV-Positive DLBCL, Nos | EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | ALIAS | 0.90 |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SGR-1505 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- 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.
- interventionNames
- Drug: SGR-1505
Primary outcomes (2)
- measure
- Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation.
- timeFrame
- Throughout the study, up to 2 years.
- measure
- Nature and number of incidences of dose limiting toxicity (DLT).
- timeFrame
- The first 21 days.
- description
- A DLT is an AE that requires treatment interruption.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.