Menu
Recruiting NCT06220864

SNV1521 in Participants With Advanced Solid Tumors

Phase I Interventional Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SNV1521, DB-1310, Abiraterone, Darolutamide.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Belgium, Canada, France +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Smilow Cancer Hospital at Yale New Haven — New Haven
  • Thomas Jefferson University — Philadelphia
  • Sarah Cannon Research Institute — Nashville
  • The University of Texas M.D. Anderson Cancer Center — Houston
  • START Center for Cancer Care — West Valley City
Australia · 5 centers
  • Scientia Clinical Research — Randwick
  • Princess Alexandra Hospital — Woolloongabba
  • Monash Health — Clayton
  • The Alfred Hospital — Melbourne
  • Linear Clinical Research — Crawley
Belgium · 4 centers
  • The Institut Jules Bordet — Brussels
  • University Center for Clinical Research Antwerp (UNICCRA) — Edegem
  • AZ Maria Middelares — Ghent
  • AZ Groeninge — Kortrijk
Spain · 4 centers
  • NEXT Oncology - Barcelona — Barcelona
  • Vall d'Hebron University Hospital — Barcelona
  • The START Center for Cancer Care - Madrid - CIOCC - Hospital Universitario Madrid Sanchina — Madrid
  • NEXT Oncology - Hospital Quironsalud Madrid — Madrid
France · 3 centers
  • Institut Bergonie — Bordeaux
  • UNICANCER - Centre Leon-Berard (CLB) — Lyon
  • Gustave Roussy — Villejuif
Canada · 2 centers
  • Arthur J.E. Child Comprehensive Cancer Centre — Calgary
  • Princess Margaret Hospital — Toronto
Italy · 2 centers
  • Istituto Clinico Humanitas — Milan
  • Istituto Europeo di Oncologia (IEO) (European Institute of Oncology) — Milan

Identifiers

NCT: NCT06220864 · SNV1521-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗