Clinical Trial

Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab

Recruiting Phase 1/2
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Summary
Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients with Advanced Solid Tumors as a Monotherapy or in Combination with Pembrolizumab. The study now includes a monotherapy cohort targeting visceral lesions and a separate Phase 2 monotherapy cohort for advanced melanoma.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2024-02-06; most recent amendment 2025-10-27.
Status change: Not Yet Recruiting → Recruiting 2024-05-07
Trial Details
NCT Number NCT06249048
Lead Sponsor Strand Therapeutics Inc.
Conditions Advanced Solid Tumor
Enrollment 108 participants
Start Date 2024-05-03
Primary Completion 2027-05 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2025-10-29