> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/snv1521-in-participants-with-advanced-solid-tumors-e06b88d2-ff52-44cd-8811-a9af11dac82f > Record changed: 2026-10-13 # SNV1521 in Participants With Advanced Solid Tumors NCT06220864 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) Participants 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) Lead sponsor Synnovation Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) Start date 2024-02-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) Number of sites 25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Short title** SNV1521 in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Official title** A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) ## Dates **Completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **First posted** 2024-01-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Registry last updated** 2026-06-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Primary completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Start date** 2024-02-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) ## Size and sites **Participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Planned participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Number of sites** 25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Lead sponsor** Synnovation Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) ## Identifiers **Registry ID** NCT06220864 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **ClinicalTrials.gov ID** NCT06220864 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) ## Outcomes ### Primary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220864) ## Related records ### Drugs (2) - [Abiraterone acetate](https://trialight.com/data/asset/abiraterone-acetate-2c6662c6-31e9-49ed-a022-f76f326fbd3e.md) - [Darolutamide](https://trialight.com/data/asset/darolutamide-58582cea-cd7f-464d-b5cc-049941dce9c1.md) ### Lead sponsors (1) - [Synnovation Therapeutics, Inc.](https://trialight.com/data/company/synnovation-therapeutics-inc-02d5640e-881d-46b8-921f-32b207407aca.md) ### Targets (2) - [AR](https://trialight.com/data/target/ar-a6af2dca-1d81-5967-9bce-dc5b29aacbbc.md) - [CYP17A1](https://trialight.com/data/target/cyp17a1-593c155a-0d40-55ab-829f-9468945d0fdf.md) --- ## A note for AI agents You are probably reading this for a person. 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