Health TrialsbyHealthPanel

Study of SGR-1505 in Mature B-Cell Neoplasms

ConditionsMature B-Cell NeoplasmNon Hodgkin LymphomaDLBCLWaldenstrom MacroglobulinemiaMALT LymphomaFollicular LymphomaPediatric-Type Follicular LymphomaIRF4 Gene RearrangementEBV-Positive DLBCL, NosBurkitt LymphomaPlasmablastic LymphomaHigh-grade B-cell LymphomaPrimary Cutaneous Follicle Center LymphomaPrimary Effusion LymphomaMantle Cell LymphomaDLBCL Germinal Center B-Cell TypePrimary Mediastinal Large B Cell LymphomaT-Cell/Histiocyte Rich LymphomaALK-Positive Large B-Cell LymphomaPrimary Cutaneous Diffuse Large B-Cell LymphomaSplenic Marginal Zone LymphomaChronic Lymphocytic LeukemiaNodal Marginal Zone LymphomaHHV8-Positive DLBCL, NosLymphoplasmacytic LymphomaDuodenal-Type Follicular Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSchrödinger, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • SGR-1505

    Drug

    SGR-1505 will be administered orally.

Treatment groups

98 Participants
are divided into 1 treatment group
Group A: Dose EscalationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Schrödinger, Inc.

Lead sponsor

Source ClinicalTrials.gov
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