SNV1521 in Participants With Advanced Solid Tumors

NCT06220864
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Recruiting
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Participants
400
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Lead sponsor
Synnovation Therapeutics, Inc.
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Start date
2024-02-23
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Number of sites
25
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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.
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Short title
SNV1521 in Participants With Advanced Solid Tumors
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Official title
A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants With Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-12-01
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First posted
2024-01-24
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Registry last updated
2026-06-25
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Primary completion date
2027-12-01
clinicaltrials.gov
Start date
2024-02-23
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Participants
400
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Participant count basis
Estimated
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Planned participants
400
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Protocol amendments
2
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Number of sites
25
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Registry sponsor category
Industry
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Lead sponsor
Synnovation Therapeutics, Inc.
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06220864
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06220864
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Safety of SNV1521

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

    Treatment emergent adverse events (TEAEs)

  2. Tolerability of SNV1521

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

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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Advanced or metastatic solid tumor malignancy
  • Evaluable or Measurable disease (RECIST 1.1 Criteria).
  • ECOG Performance Status 0 or 1.
  • Life expectancy > 3 months

  • 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
Sources for eligibility
clinicaltrials.gov

  • Smilow Cancer Hospital at Yale New HavenNew Haven, United StatesRecruiting
  • Thomas Jefferson UniversityPhiladelphia, United StatesRecruiting
  • Sarah Cannon Research InstituteNashville, United StatesRecruiting
  • The University of Texas M.D. Anderson Cancer CenterHouston, United StatesRecruiting
  • START Center for Cancer CareWest Valley City, United StatesRecruiting
  • Scientia Clinical ResearchRandwick, AustraliaRecruiting
  • Princess Alexandra HospitalWoolloongabba, AustraliaRecruiting
  • Monash HealthClayton, AustraliaRecruiting
  • The Alfred HospitalMelbourne, AustraliaRecruiting
  • Linear Clinical ResearchCrawley, AustraliaRecruiting
  • The Institut Jules BordetBrussels, BelgiumRecruiting
  • University Center for Clinical Research Antwerp (UNICCRA)Edegem, BelgiumRecruiting
  • AZ Maria MiddelaresGhent, BelgiumRecruiting
  • AZ GroeningeKortrijk, BelgiumRecruiting
  • Arthur J.E. Child Comprehensive Cancer CentreCalgary, CanadaRecruiting
  • Princess Margaret HospitalToronto, CanadaRecruiting
  • Institut BergonieBordeaux, FranceRecruiting
  • UNICANCER - Centre Leon-Berard (CLB)Lyon, FranceRecruiting
  • Gustave RoussyVillejuif, FranceRecruiting
  • Istituto Clinico HumanitasMilan, ItalyRecruiting
  • Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)Milan, ItalyRecruiting
  • NEXT Oncology - BarcelonaBarcelona, SpainRecruiting
  • Vall d'Hebron University HospitalBarcelona, SpainRecruiting
  • The START Center for Cancer Care - Madrid - CIOCC - Hospital Universitario Madrid SanchinarroMadrid, SpainRecruiting
  • NEXT Oncology - Hospital Quironsalud MadridMadrid, SpainRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Targets (2)