SNV1521 in Participants with Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: SNV1521; Drug: Trastuzumab Deruxtecan

• Registration Number: NCT06220864
• Lead Sponsor: Synnovation Therapeutics, Inc.

Brief 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. They are also investigating whether it can be combined with other cancer therapies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-01-24
• Study Start: 2024-02-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	SNV1521	-
Dose Expansion	SNV1521	-
Combination Dose Escalation	SNV1521	-
Combination Dose Escalation	Trastuzumab Deruxtecan	-
Dose Expansion for Metastatic Castration Resistant Prostate Cancer	SNV1521	-
Dose Expansion for Pancreatic Ductal Adenocarcinoma	SNV1521	-
Dose Expansion for Solid Tumors with Brain Metastases	SNV1521	-

Primary Outcome Measures

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

Trial Locations

Locations (9)

Yale University; 🇺🇸 New Haven, Connecticut, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

The University of Texas M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

START Center for Cancer Care; 🇺🇸 West Valley City, Utah, United States

Scientia Clinical Research; 🇦🇺 Randwick, New South Wales, Australia

Linear Clinical Research; 🇦🇺 Crawley, Western Australia, Australia