NCT06249048
Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab
Recruiting · Phase 1, Phase 2 · Strand Therapeutics Inc. · registry updated 2025-10-29
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- ≥ 18 years of age at the time of screening.
- Mentally competent and able to understand and sign the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 12 weeks per the Investigator.
- Body weight ˃ 40 kg.
- At least 4 weeks from any prior major surgery.
Exclusion
- History of primary immune deficiency.
- History of autoimmune disease and/or requiring immunosuppression (except hypothyroidism).
- History of History of Grade 3 or higher immune-related adverse events. Patient may be enrolled with Medical Monitor approval.
- History of solid organ transplant and taking immunosuppressive medications.
- Cardiovascular exclusions: Medical history of an arterial thrombotic event, stroke, or transient ischemic attack within the past 12 months; medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a cardiac arrhythmia that required treatment within the past 12 months; medical history of myocardial infarction or unstable angina within 6 months before Cycle 1 Day 1; QTcF prolongation to \> 470 ms in women and \> 450 ms in men based on a 12-lead electrocardiogram (ECG) in triplicate using the Fridericia formula: QTc = QT / RR1/3.
- Recent medical concerns exclusions: