SNV1521 in Participants With Advanced Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: SNV1521

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Robert Casper; Phone Number: 443-764-9527; Email: rcasper@synnovationtx.com

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Recruiting
      • Scientia Clinical Research
• United States
  • 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

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Advanced or metastatic solid tumor malignancy
• Refractory to or intolerant of available therapies
• Evaluable or Measurable disease (RECIST 1.1 Criteria).
• ECOG Performance Status 0 or 1.
• Life expectancy > 3 months

Exclusion Criteria:

• Active brain metastasis or carcinomatous meningitis
• History of other malignancy within the past 2 years
• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation	Drug: SNV1521; SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
Experimental: Dose Expansion	Drug: SNV1521; SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of SNV1521	Treatment emergent adverse events (TEAEs)	From first dose through last dose (up to 13 months)
Tolerability of SNV1521	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

• Sponsor: Synnovation Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

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): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• 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