RecruitingPhase 1NCT06220864

SNV1521 in Participants With Advanced Solid Tumors

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


Sponsor

Synnovation Therapeutics, Inc.

Enrollment

400 participants

Start Date

Feb 23, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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

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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.


Locations(21)

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

START Center for Cancer Care

West Valley City, Utah, United States

Scientia Clinical Research

Randwick, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Linear Clinical Research

Crawley, Western Australia, Australia

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Institut Bergonie

Bordeaux, France

UNICANCER - Centre Leon-Berard (CLB)

Lyon, France

Gustave Roussy

Villejuif, France

Istituto Clinico Humanitas

Milan, Italy

Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)

Milan, Italy

NEXT Oncology - Barcelona

Barcelona, Spain

Vall d'Hebron University Hospital

Barcelona, Spain

The START Center for Cancer Care - Madrid - CIOCC - Hospital Universitario Madrid Sanchinarro

Madrid, Spain

NEXT Oncology - Hospital Quironsalud Madrid

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT06220864


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