SNV1521 in Participants With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220864
• Other study ID #: SNV1521-101
• Status: Recruiting
• Phase: Phase 1
• Start date: February 23, 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Synnovation Therapeutics, Inc.
• Contact: Robert Casper
• Phone: 443-764-9527
• Email: rcasper[@]synnovationtx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Australia	Linear Clinical Research	Crawley	Western Australia
Australia	Scientia Clinical Research	Randwick	New South Wales
United States	The University of Texas M.D. Anderson Cancer Center	Houston	Texas
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	START Center for Cancer Care	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Synnovation Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of SNV1521	Treatment emergent adverse events (TEAEs)	From first dose through last dose (up to 13 months)
Primary	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)