Study of SGR-1505 in Mature B-Cell Neoplasms

Sponsor
Schrödinger, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05544019
Collaborator
(none)
52
2
18

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-1505.

Detailed Description

This is a study of SGR-1505 in subjects with relapsed/refractory (R/R) B-cell lymphomas to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) 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 sub-study will evaluate the effect of food and drug-drug interactions. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose Escalation

Up to 11 dose levels will be evaluated. 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.

Experimental: FE/DDI Cohort

Participants will be dosed in a fed (high-fat, high-calorie meal) and fasted state to determine the effect of food on bioavailability of SGR-1505. Participants will be dosed with and without Posaconazole to determine the effect on the exposure of SGR-1505.

Drug: SGR-1505
SGR-1505 will be administered orally.

Outcome Measures

Primary Outcome Measures

  1. Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation. [Throughout the study, up to 2 years.]

  2. Nature and number of incidences of dose limiting toxicity (DLT). [The first 21 days.]

    A DLT is an AE that requires treatment interruption.

Secondary Outcome Measures

  1. SGR-1505 Maximal Plasma Concentration (Cmax) [Through study completion, up to 2 years.]

    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).

  2. SGR-1505 Time to Maximal Plasma Concentration (tmax) [Through study completion, up to 2 years.]

    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).

  3. SGR-1505 Area Under the Concentration Versus Time Curve (AUC) [Through study completion, up to 2 years.]

    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).

  4. Effect of Food on the Cmax of SGR-1505 [Throughout the study, up to 2 years.]

    Plasma exposure parameters for SGR-1505 including, but not limited to, Cmax are evaluated following its administration with and without food.

  5. Effect of Food on the tmax of SGR-1505 [Throughout the study, up to 2 years.]

    Plasma exposure parameters for SGR-1505 including, but not limited to, tmax, are evaluated following its administration with and without food.

  6. Effect of Food on the AUC of SGR-1505 [Throughout the study, up to 2 years.]

    Plasma exposure parameters for SGR-1505 including, but not limited to, AUC are evaluated following its administration with and without food.

  7. Effect of Posaconazole on the Cmax of SGR-1505 [Through study completion, up to 2 years.]

    Plasma exposure parameters for SGR-1505 including, but not limited to, Cmax are evaluated following its administration alone and after co-administration with Posaconazole, a typical CYP3A4 inhibitor.

  8. Effect of Posaconazole on the tmax of SGR-1505 [Through study completion, up to 2 years.]

    Plasma exposure parameters for SGR-1505 including, but not limited to, tmax, are evaluated following its administration alone and after co-administration with Posaconazole, a typical CYP3A4 inhibitor.

  9. Effect of Posaconazole on the AUC of SGR-1505 [Through study completion, up to 2 years.]

    Plasma exposure parameters for SGR-1505 including, but not limited to, AUC are evaluated following its administration alone and after co-administration with Posaconazole, a typical CYP3A4 inhibitor.

  10. Objective Response Rate (ORR) [Throughout the study, up to 2 years.]

    Number of patients who have a complete response (CR) or partial response (PR) to treatment.

  11. Duration of Response (DOR) [Throughout the study, up to 2 years.]

    The time from response CR/PR until relapse or death from any cause.

  12. Disease Control Rate [Throughout the study, up to 2 years.]

    PR, CR, and SD for 2 post-baseline disease assessments at least 6 weeks apart.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

  • Life expectancy ≥ 12 weeks.

Exclusion Criteria:
  • For a subject with indolent NHL and CLL/SLL, the subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit) and has an indication for treatment.

  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Schrödinger, Inc.

Investigators

  • Study Director: Daniel Weiss, M.D., Schrodinger Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Schrödinger, Inc.
ClinicalTrials.gov Identifier:
NCT05544019
Other Study ID Numbers:
  • SGR-1505-101
First Posted:
Sep 16, 2022
Last Update Posted:
Sep 16, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2022