Testing SNV1521 for advanced solid tumors
A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants With Advanced Solid Tumors
PHASE1 · Synnovation Therapeutics, Inc. · NCT06220864
This study is testing a new medication called SNV1521 to see if it is safe and effective for people with advanced solid tumors, and whether it works well when combined with other cancer treatments.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Synnovation Therapeutics, Inc. (industry) |
| Locations | 21 sites (New Haven, Connecticut and 20 other locations) |
| Trial ID | NCT06220864 on ClinicalTrials.gov |
What this trial studies
This study is evaluating a new medication called SNV1521 in patients with advanced solid tumors. The primary focus is to assess the safety, tolerability, and effectiveness of SNV1521, including its optimal dosing. Additionally, the study will explore the potential of combining SNV1521 with other cancer treatments, such as Trastuzumab Deruxtecan. Participants will be monitored for their response to the treatment based on established criteria.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced or metastatic solid tumors who have a life expectancy of more than three months and meet specific health criteria.
Not a fit: Patients with a history of other malignancies within the past two years or significant cardiovascular or gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.
How similar studies have performed: While this approach is being tested, similar studies have shown promise in evaluating new cancer therapies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Haven, Connecticut and 20 other locations
- Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut, United States (RECRUITING)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (RECRUITING)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (RECRUITING)
- The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- START Center for Cancer Care — West Valley City, Utah, United States (RECRUITING)
- Scientia Clinical Research — Randwick, New South Wales, Australia (RECRUITING)
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (RECRUITING)
- Monash Health — Clayton, Victoria, Australia (RECRUITING)
- The Alfred Hospital — Melbourne, Victoria, Australia (RECRUITING)
- Linear Clinical Research — Crawley, Western Australia, Australia (RECRUITING)
- Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada (RECRUITING)
- Princess Margaret Hospital — Toronto, Ontario, Canada (RECRUITING)
- Institut Bergonie — Bordeaux, France (RECRUITING)
- UNICANCER - Centre Leon-Berard (CLB) — Lyon, France (RECRUITING)
- Gustave Roussy — Villejuif, France (RECRUITING)
- Istituto Clinico Humanitas — Milan, Italy (RECRUITING)
- Istituto Europeo di Oncologia (IEO) (European Institute of Oncology) — Milan, Italy (RECRUITING)
- NEXT Oncology - Barcelona — Barcelona, Spain (RECRUITING)
- Vall d'Hebron University Hospital — Barcelona, Spain (RECRUITING)
- The START Center for Cancer Care - Madrid - CIOCC - Hospital Universitario Madrid Sanchinarro — Madrid, Spain (RECRUITING)
- NEXT Oncology - Hospital Quironsalud Madrid — Madrid, Spain (RECRUITING)
Study contacts
- Study coordinator: Robert Casper
- Email: rcasper@synnovationtx.com
- Phone: 443-764-9527
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumor