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Evaluating SGR-1505 for treating 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

Phase 1 Interventional Schrödinger, Inc. · NCT05544019

This study is testing a new oral medication called SGR-1505 to see if it is safe and effective for people with certain types of B-cell lymphomas that have not responded to other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment98 (estimated)
Ages18 Years and up
SexAll
SponsorSchrödinger, Inc. Industry-sponsored
Locations36 sites (Gilbert, Arizona and 35 other locations)
Trial IDNCT05544019 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of SGR-1505, an oral inhibitor of MALT1, in patients with relapsed or refractory B-cell lymphomas. It aims to determine the maximum tolerated dose (MTD) and assess pharmacokinetics (PK) and pharmacodynamics (PD) of the drug. Additionally, exploratory cohorts will investigate preliminary anti-tumor activity and safety, with plans to evaluate SGR-1505 in combination with other anti-cancer agents for specific B-cell malignancies.

Who should consider this trial

Good fit: Ideal candidates include individuals with relapsed or refractory mature B-cell malignancies who have measurable disease and an ECOG performance status of 0 or 1.

Not a fit: Patients requiring immediate cytoreductive therapy or those with symptomatic CNS involvement of the disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.

How similar studies have performed: Other studies have shown promise with similar approaches targeting MALT1, indicating potential for success in this area.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Gilbert, Arizona and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Mature B-Cell NeoplasmNon Hodgkin LymphomaDLBCLWaldenstrom MacroglobulinemiaMALT LymphomaFollicular LymphomaPediatric-Type Follicular LymphomaIRF4 Gene Rearrangement
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.