A Phase I, Multi-center, Dose-escalation, Dose expansion Study to Evaluate the Safety, Efficacy, Pharmacokinetics, Pharmacodynamics of SGR-1505 as a Monotherapy and as a Combination Therapy with other BTK and BCL-2 inhibitors in Patients with Advanced, Relapsed or Refractory B-cell Malignancies

Study Identifier:
SGR-1505-101
CT.gov Identifier:
NCT05544019
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-505204-34-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To evaluate the safety, efficacy, pharmacokinetics, pharmacodynamics of SGR-1505 as a monotherapy in patients with advanced, relapsed or refractory B-cell malignancies.

To determine recommended dose for expansion study

Expansion study: To evaluate SGR-1505 in combination with other anti-cancer agents, such as BTK and BCL-2 inhibitors, in patients with specific B-cell malignancies.

To evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-1505.

To evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-1505.

SGR-1505 plasma PK and ex vivo inhibition of T-cell-derived IL-2 (PD marker of MALT1 inhibition) were evaluated from blood draws. Disease assessments occurred every 12 weeks using disease-specific standard response criteria.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Lymphoma
  • Waldenstrom Macroglobulinemia
  • Gene Mutations
  • NOS
  • Leukemia
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Patients will receive SGR-1505 as a monotherapy in dose escalation part and incombination with other anti-cancer agents, such as BTK and BCL-2 inhibitors in dose-expansion part
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  • Drug: Experimental: Dose Escalation
  • Drug: Exploratory cohorts (n > or = 24)
  • Drug: Pts received oral SGR-1505 daily in 21-day cycles in a modified 3+3 dose escalation design once daily (QD) or twice daily (Q12H). Safety evaluations occurred weekly for 2 cycles, then every 3 weeks.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.
    • Key inclusion criteria are: history of mature B-cell malignancy (including aggressive and indolent B-cell lymphomas,Waldenström macroglobulinemia, and CLL); measurable or detectable disease according to the applicable disease-specific classification system (Lugano, iwCLL, WWM6); Eastern Cooperative Oncology Group (ECOG) performancestatus of ≤ 2. Patients with indolent B-cell lymphomas or CLL must have an indication for treatment and notrequire immediate cytoreductive therapy.
    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.
    • subjects with symptomatic or active CNS involvement, and other conditions or laboratory findings placing them at increased risk to the use of an investigational drug are excluded.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Damian Cubillas
    Status
    Recruiting
    Condition(s) Treated at Site
    Lymphoma
    Waldenstrom Macroglobulinemia
    Gene Mutations
    NOS
    Leukemia
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Daniel Morillo Giles
    Status
    Recruiting
    Condition(s) Treated at Site
    Lymphoma
    Waldenstrom Macroglobulinemia
    Gene Mutations
    NOS
    Leukemia