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 — DRUG
    SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
  • DB-1310 — DRUG
    DB-1310 is given as an infusion. Dose and frequency are dependent upon treatment arm.
  • Abiraterone — DRUG
    Abiraterone is taken orally. Dose and frequency are per approved prescribing instructions.
  • Darolutamide — DRUG
    Darolutamide 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

Locations (5)

FacilityCityStateZIPSite coordinators
Smilow Cancer Hospital at Yale New HavenNew HavenConnecticut06511-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19144-
Sarah Cannon Research InstituteNashvilleTennessee37203-
The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-
START Center for Cancer CareWest Valley CityUtah84119-

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