A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants with Advanced Solid Tumors

Study Identifier:
SNV1521-101
CT.gov Identifier:
NCT06220864
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
2025-520557-36-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

This study is testing a new medicine, SNV1521, for people with advanced cancers. The researchers want to find out if SNV1521 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the most effective and safe one. They are also investigating whether it can be combined with other cancer therapies.

Dose escalation evaluated once-daily (QD) doses (5-30 mg) in advanced solid tumors with germline or somatic deleterious BRCA1/2, PALB2, RAD51/52/54, CDK12, and CHEK1/2 mutations, with prior PARPi allowed.

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.
  • Solid Tumor
    • 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: Experimental: Monotherapy Dose EscalationDrug: SNV1521
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Advanced or metastatic solid tumor malignancy
    • Evaluable or Measurable disease (RECIST 1.1 Criteria).
    • ECOG Performance Status 0 or 1.
    • Life expectancy > 3 months
    Exclusion criteria
    • History of other malignancy within the past 2 years
    • Prior diagnosis of Myelodysplastic syndrome or Acute Myeloid Leukemia
    • Significant cardiovascular disease within 6 months
    • Significant gastrointestinal disease
    • HIV infection with a CD4+ T-cell count < 200 cells/L and/or a detectable viral load
    • Liver dysfunction

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    Justin Call
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor