A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies
Overview
- Phase
- Phase 1
- Intervention
- SGR-1505
- Conditions
- Mature B-Cell Neoplasm
- Sponsor
- Schrödinger, Inc.
- Enrollment
- 98
- Locations
- 50
- Primary Endpoint
- Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation.
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility 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
- •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-
- •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.
Arms & Interventions
Dose Escalation
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.
Intervention: SGR-1505
Outcomes
Primary Outcomes
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).
Time Frame: The first 21 days.
A DLT is an AE that requires treatment interruption.
Secondary Outcomes
- SGR-1505 Time to Maximal Plasma Concentration (tmax)(Through study completion, up to 2 years.)
- SGR-1505 Area Under the Concentration Versus Time Curve (AUC)(Through study completion, up to 2 years.)
- Objective Response Rate (ORR)(Throughout the study, up to 2 years.)
- SGR-1505 Maximal Plasma Concentration (Cmax)(Through study completion, up to 2 years.)
- Duration of Response (DOR)(Throughout the study, up to 2 years.)
- Disease Control Rate(Throughout the study, up to 2 years.)