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RecruitingInterventionalPhase 1

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

NCT ID: NCT06220864Sponsor: Synnovation Therapeutics, Inc.Last updated: 2026-04-14

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.

Arms & interventions

  • DrugSNV1521

    SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.

  • DrugDB-1310

    DB-1310 is given as an infusion. Dose and frequency are dependent upon treatment arm.

  • DrugAbiraterone

    Abiraterone is taken orally. Dose and frequency are per approved prescribing instructions.

  • DrugDarolutamide

    Darolutamide is taken orally. Dose and frequency are per approved prescribing instructions.

Outcome measures

Primary

  • Safety of SNV1521

    Treatment emergent adverse events (TEAEs)

    Time frame: From first dose through last dose (up to 13 months)

  • Tolerability of SNV1521

    Incidence and frequency of dose-limiting toxicities (DLTs) (Dose-escalation arm only)

    Time frame: DLTs: From first dose through completion of first cycle (28 days)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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/μL and/or a detectable viral load * Liver dysfunction

Study locations (5)

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, 06511

Recruiting

Thomas Jefferson University

Philadelphia, Pennsylvania, 19144

Recruiting

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Recruiting

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030

Recruiting

START Center for Cancer Care

West Valley City, Utah, 84119

Recruiting