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NCT06249048 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab
A Phase 1 study of Advanced Solid Tumor, sponsored by Strand Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 108
- Enrollment target
- 7
- Study locations
NCT06249048: Recruiting Phase 1 study of Advanced Solid Tumor, sponsored by Strand Therapeutics.
NCT06249048 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by Strand Therapeutics. The registered enrollment target is 108 participants, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (44% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06249048, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by Strand Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 108 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
The occurrence of DLTs, TEAEs, and SAEs will be used to determine the maximum tolerated dose and recommended Phase 2 dose of STX-001.
Conditions Studied
Interventions
- BIOLOGICAL STX-001
- BIOLOGICAL Keytruda®
Study Locations (7)
Arizona
- HonorHealth Research and Innovation Institute - Scottsdale
California
- NextGen Oncology - Beverly Hills
Ohio
- Cleveland Clinic - Cleveland
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Utah
- Huntsman Cancer Institute - University of Utah - Salt Lake City
Other
- Melanoma Institute Australia - Wollstonecraft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2024-05-03 |
| Est. Completion | 2028-11 |
| Phase | Phase 1 |
What NCT06249048 shows while recruiting
NCT06249048 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which STX-001 is the first listed.
NCT06249048 lists 7 locations in 7 states (Arizona, California, Ohio).
Frequently Asked Questions
What is clinical trial NCT06249048 about?
NCT06249048 is a clinical study titled "Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab". 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...
What is the current status of trial NCT06249048?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 108 participants. The study started on 2024-05-03. Estimated completion is 2028-11.
What conditions does trial NCT06249048 study?
This clinical trial studies the following conditions: Advanced Solid Tumor.
What interventions are being tested in trial NCT06249048?
The interventions under investigation include: STX-001 (BIOLOGICAL), Keytruda® (BIOLOGICAL).
Who is sponsoring clinical trial NCT06249048?
This trial is sponsored by Strand Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06249048 being conducted?
This trial has 7 study locations across Arizona, California, Ohio, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06249048's enrollment target sits among peer trials
108 111th of 189 higher than 79 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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