Recruiting
Phase 1

SNV1521

Sponsor:

Synnovation Therapeutics, Inc.

Code:

NCT06220864

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SNV1521

DB-1310

Abiraterone

Darolutamide

Study Details

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.

Conditions

Advanced Solid Tumor

Study ID

NCT06220864

Start date

Feb 23, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

SNV1521

SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.

DB-1310

DB-1310 is given as an infusion. Dose and frequency are dependent upon treatment arm.

Abiraterone

Abiraterone is taken orally. Dose and frequency are per approved prescribing instructions.

Darolutamide

Darolutamide is taken orally. Dose and frequency are per approved prescribing instructions.

Primary outcome measure

  • Safety of SNV1521 [ Time Frame: From first dose through last dose (up to 13 months) ]
  • Tolerability of SNV1521 [ Time Frame: DLTs: From first dose through completion of first cycle (28 days) ]

Central Contacts and Locations

Central contacts

Robert Casper

443-764-9527rcasper@synnovationtx.com

Locations

Smilow Cancer Hospital at Yale New Haven

Recruiting

New Haven, Connecticut, United States, 06511

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19144

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

The University of Texas M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

START Center for Cancer Care

Recruiting

West Valley City, Utah, United States, 84119

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

Synnovation Therapeutics, Inc.

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Synnovation Therapeutics, Inc. on 2026-06-25.