SNV1521 in Participants With Advanced Solid Tumors
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Synnovation Therapeutics, Inc.
- Study ID
- NCT06220864
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Advanced Solid Tumor
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- SNV1521 — DRUGSNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
- DB-1310 — DRUGDB-1310 is given as an infusion. Dose and frequency are dependent upon treatment arm.
- Abiraterone — DRUGAbiraterone is taken orally. Dose and frequency are per approved prescribing instructions.
- Darolutamide — DRUGDarolutamide is taken orally. Dose and frequency are per approved prescribing instructions.
Study Details
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.
Key Dates
- Start date
- Feb 23, 2024
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 400 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Monotherapy Dose Escalation
- Experimental: Monotherapy Dose Expansion
- Experimental: Combination Dose Escalation
- Experimental: Dose Expansion for Metastatic Castration Resistant Prostate Cancer
- Experimental: Dose Expansion for Pancreatic Ductal Adenocarcinoma
- Experimental: Dose Expansion for Solid Tumors with Brain Metastases
- Experimental: Dose Expansion for Breast Cancer
- Experimental: Dose Expansion for Ovarian, Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
- Experimental: Combination 1 Dose Expansion for mCRPC or mCSPC
- Experimental: Combination 2 Dose Expansion for mCRPC or mCSPC
Primary Outcome Measure
Safety of SNV1521 [ Time Frame: From first dose through last dose (up to 13 months) ]
Central Contacts
- Robert Casper443-764-9527
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | 06511 | - |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19144 | - |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | - |
| The University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | - |
| START Center for Cancer Care | West Valley City | Utah | 84119 | - |
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