ClinicalTrials.gov record NCT05544019

Study of SGR-1505 in Mature B-Cell Neoplasms

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Age18 years old and older
SexAll
LocationFrance, Italy, Moldova, Poland, Romania, Spain, Ukraine, United States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1, open-label study gives oral SGR-1505 as monotherapy to people with relapsed or refractory mature B‑cell cancers to evaluate safety, tolerability, and appropriate dosing. Participants are assigned sequentially to dose‑escalation cohorts (an accelerated titration that transitions to a traditional 3+3 design) to identify the maximum tolerated, maximum administered, and/or recommended dose. The study also measures how the drug behaves in the body (pharmacokinetics and pharmacodynamics) and collects early information on anti‑tumor activity; a planned amendment may test SGR-1505 in combination with other cancer agents.

What it is studying. Whether oral SGR-1505 is safe and tolerable at increasing dose levels, what dose should be recommended for future studies, how the drug is processed in the body (pharmacokinetics and pharmacodynamics), and whether there are initial signs of anti‑tumor activity.

What the researchers hope to learn. Define the safety and tolerability profile of SGR-1505; determine the maximum tolerated dose (MTD), maximum administered dose (MAD), and/or recommended dose (RD); characterize pharmacokinetics (PK) and pharmacodynamics (PD); and explore preliminary anti‑tumor activity. A planned amendment will evaluate SGR-1505 in combination with other anti-cancer agents.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • SGR-1505

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will take SGR-1505 orally as part of a dose‑escalation plan and will be assigned to successive dose cohorts (up to 9 dose levels across two dosing schedules). They will attend regular clinic visits for safety checks and monitoring of adverse events, with particularly close observation in the first 21 days for any dose‑limiting toxicities. Blood samples will be taken repeatedly to measure drug levels (pharmacokinetics) and pharmacodynamic effects, and participants will undergo scheduled disease assessments to evaluate tumor response and disease control. Follow-up and safety monitoring continue through study completion, up to about 2 years.

How the study is structured. Open-label, non-randomized Phase 1 dose-escalation study. Participants receive oral SGR-1505 in assigned dose cohorts across up to nine dose levels and two dosing schedules, using an accelerated titration that transitions to a 3+3 escalation. The study tracks adverse events (including dose-limiting toxicities in the first 21 days), measures drug levels in plasma over time, and assesses tumor response and safety over up to two years.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in France, Italy, Moldova, Poland, Romania, Spain, Ukraine, United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Waldenström macroglobulinemia

This trial is also listed on this site under splenic marginal zone lymphoma.

Clinical trials63 trials listed for Waldenström macroglobulinemiaEvery trial the registry lists for Waldenström macroglobulinemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Waldenström macroglobulinemia researchLatest monthly update: September 2026. Includes: Upfront treatment outcomes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Apr 10, 2023
Primary completion
November 2027 (estimated)
Study completion
November 2027 (estimated)
Target enrollment
98 participants (estimated)
Last updated on registry
Feb 13, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Schrödinger, Inc.

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (36)

Terms used on this page · explanations by MedicalUpdates.ai

maximum tolerated dose
The highest dose found in a dose-escalation study that can be given without too many dose-limiting side effects.
ECOG
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
Life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
investigational drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
relapsed/refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
pharmacokinetics
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
pharmacodynamics
What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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