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
1 other identifier
interventional
400
6 countries
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2024
Typical duration for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2024
CompletedFirst Posted
Study publicly available on registry
January 24, 2024
CompletedStudy Start
First participant enrolled
February 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 14, 2026
April 1, 2026
3.8 years
January 12, 2024
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Safety of SNV1521
Treatment emergent adverse events (TEAEs)
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)
DLTs: From first dose through completion of first cycle (28 days)
Study Arms (10)
Monotherapy Dose Escalation
EXPERIMENTALMonotherapy Dose Expansion
EXPERIMENTALCombination Dose Escalation
EXPERIMENTALDose Expansion for Metastatic Castration Resistant Prostate Cancer
EXPERIMENTALDose Expansion for Pancreatic Ductal Adenocarcinoma
EXPERIMENTALDose Expansion for Solid Tumors with Brain Metastases
EXPERIMENTALDose Expansion for Breast Cancer
EXPERIMENTALDose Expansion for Ovarian, Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
EXPERIMENTALCombination 1 Dose Expansion for mCRPC or mCSPC
EXPERIMENTALCombination 2 Dose Expansion for mCRPC or mCSPC
EXPERIMENTALInterventions
SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
DB-1310 is given as an infusion. Dose and frequency are dependent upon treatment arm.
Abiraterone is taken orally. Dose and frequency are per approved prescribing instructions.
Darolutamide is taken orally. Dose and frequency are per approved prescribing instructions.
Eligibility Criteria
You may qualify if:
- Advanced or metastatic solid tumor malignancy
- Evaluable or Measurable disease (RECIST 1.1 Criteria).
- ECOG Performance Status 0 or 1.
- Life expectancy \> 3 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06511, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19144, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
START Center for Cancer Care
West Valley City, Utah, 84119, United States
Scientia Clinical Research
Randwick, New South Wales, 2031, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Monash Health
Clayton, Victoria, 3168, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Linear Clinical Research
Crawley, Western Australia, 6009, Australia
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Institut Bergonie
Bordeaux, 33076, France
UNICANCER - Centre Leon-Berard (CLB)
Lyon, 69008, France
Gustave Roussy
Villejuif, 94805, France
Istituto Clinico Humanitas
Milan, 20089, Italy
Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)
Milan, 20141, Italy
NEXT Oncology - Barcelona
Barcelona, 08023, Spain
Vall d'Hebron University Hospital
Barcelona, 08035, Spain
The START Center for Cancer Care - Madrid - CIOCC - Hospital Universitario Madrid Sanchinarro
Madrid, 28050, Spain
NEXT Oncology - Hospital Quironsalud Madrid
Madrid, 28223, Spain
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2024
First Posted
January 24, 2024
Study Start
February 23, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
April 14, 2026
Record last verified: 2026-04