A Phase 1 interventional study of SGR-1505 in Mature B-Cell Neoplasm, Non Hodgkin Lymphoma and DLBCL, sponsored by Schrödinger, Inc.. Recruiting at 36 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Schrödinger, Inc. · Phase 1, Interventional, and Treatment
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.
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.
2,287 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 287 are open to participants now.
This study's planned enrollment of 98 is above the median of 40 across 1,883 interventional studies indexed under Lymphoma, Non-Hodgkin.
Browse Lymphoma, Non-Hodgkin studies →Schrödinger, Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: SGR-1505
SGR-1505 will be administered orally.
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.
Nature and number of incidences of dose limiting toxicity (DLT).
A DLT is an AE that requires treatment interruption.
Time frame: The first 21 days.
SGR-1505 Maximal Plasma Concentration (Cmax)
Concentrations of SGR-1505 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the maximal plasma concentration (Cmax).
Time frame: Through study completion, up to 2 years.
SGR-1505 Time to Maximal Plasma Concentration (tmax)
Concentrations of SGR-1505 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the time to maximal plasma concentration (tmax).
Time frame: Through study completion, up to 2 years.
SGR-1505 Area Under the Concentration Versus Time Curve (AUC)
Concentrations of SGR-1505 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the area under the concentration versus time curve (AUC).
Time frame: Through study completion, up to 2 years.
Objective Response Rate (ORR)
Number of patients who have an objective response per response criteria other than stable disease (SD) or progressive disease (PD) to treatment.
Time frame: Throughout the study, up to 2 years.
Duration of Response (DOR)
The time from response CR/PR until relapse or death from any cause.
Time frame: Throughout the study, up to 2 years.
Disease Control Rate
PR, CR, and SD for 2 post-baseline disease assessments at least 6 weeks apart.
Time frame: Throughout the study, up to 2 years.
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Nov 2027, 55 months after the start.
Of 163 industry-sponsored phase 1 interventional studies under Lymphoma, Non-Hodgkin, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 70. This study's planned 55 months is above that.
Counting every sponsor, half of 286 studies reached it within 53 months; a quarter within 38 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
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