SNV1521 in Participants With Advanced Solid Tumors

April 9, 2026 updated by: Synnovation Therapeutics, Inc.

A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants With Advanced Solid Tumors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • Scientia Clinical Research
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
    • Western Australia
      • Crawley, Western Australia, Australia, 6009
        • Recruiting
        • Linear Clinical Research
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Arthur J.E. Child Comprehensive Cancer Centre
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Hospital
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Institut Bergonie
      • Lyon, France, 69008
        • Recruiting
        • UNICANCER - Centre Leon-Berard (CLB)
      • Villejuif, France, 94805
        • Recruiting
        • Gustave Roussy
  • Italy
      • Milan, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
      • Milan, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia (IEO) (European Institute of Oncology)
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall d'Hebron University Hospital
      • Barcelona, Spain, 08023
        • Recruiting
        • NEXT Oncology - Barcelona
      • Madrid, Spain, 28223
        • Recruiting
        • NEXT Oncology - Hospital Quironsalud Madrid
      • Madrid, Spain, 28050
        • Recruiting
        • The START Center for Cancer Care - Madrid - CIOCC - Hospital Universitario Madrid Sanchinarro
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Smilow Cancer Hospital at Yale New Haven
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19144
        • Recruiting
        • Thomas Jefferson University
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas M.D. Anderson Cancer Center
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • START Center for Cancer Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monotherapy Dose Escalation
Drug: SNV1521
SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Experimental: Combination Dose Escalation
Drug: SNV1521
SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Drug: DB-1310
DB-1310 is given as an infusion. Dose and frequency are dependent upon treatment arm.
Experimental: Dose Expansion for Metastatic Castration Resistant Prostate Cancer
Drug: SNV1521
SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Experimental: Dose Expansion for Pancreatic Ductal Adenocarcinoma
Drug: SNV1521
SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Experimental: Dose Expansion for Solid Tumors with Brain Metastases
Drug: SNV1521
SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Experimental: Monotherapy Dose Expansion
Drug: SNV1521
SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Experimental: Dose Expansion for Breast Cancer
Drug: SNV1521
SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Experimental: Dose Expansion for Ovarian, Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Drug: SNV1521
SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Experimental: Combination 1 Dose Expansion for mCRPC or mCSPC
Drug: Abiraterone
Abiraterone is taken orally. Dose and frequency are per approved prescribing instructions.
Experimental: Combination 2 Dose Expansion for mCRPC or mCSPC
Drug: Darolutamide
Darolutamide is taken orally. Dose and frequency are per approved prescribing instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of SNV1521
Time Frame: From first dose through last dose (up to 13 months)
Treatment emergent adverse events (TEAEs)
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)
Incidence and frequency of dose-limiting toxicities (DLTs) (Dose-escalation arm only)
DLTs: From first dose through completion of first cycle (28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synnovation Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNV1521-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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