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NCT Number: NCT06220864

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.

Recruiting

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Scientia Clinical Research, Randwick, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Safety of SNV1521

    Time frame: From first dose through last dose (up to 13 months)

    Treatment emergent adverse events (TEAEs)

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Casper

CONTACT

[email protected]

443-764-9527

Sponsors and collaborators

Lead sponsor

Synnovation Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 24, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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