A 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
Strand Therapeutics Inc.
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.
Description
This open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and dose expansion study involves STX-001 administration, alone or in combination with pembrolizumab, to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity in patients with advanced cancers. Phase 1 consists of 4 planned dose escalation cohorts of STX-001 delivered as a monotherapy (Cohorts 1m), 4 planned dose escalation monotherapy cohorts of STX-001 delivered as a combination therapy with pembrolizumab treatment given concurrently (Cohorts 1c), and an ad…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
General Inclusion Criteria: * ≥ 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. * Willing and able to provide blood samples prior to the start of this study. * Has a tumor lesion amenable to injection, must be accessible for pre and post injection biopsy, and the patient must be willing to consent to biopsy, if deemed…
Interventions
- BiologicalSTX-001
STX-001 encapsulates a self-replicating RNA encoded for IL-12, contained within an LNP for intratumoral injection. Injections may be administered into multiple lesions according to protocol-defined procedures.
- BiologicalKeytruda®
Pembrolizumab (Keytruda USPI 2023) is a marketed PD-1 blocking humanized monoclonal IgG4 kappa antibody.
Locations (7)
- HonorHealth Research and Innovation InstituteScottsdale, Arizona
- NextGen OncologyBeverly Hills, California
- Cleveland ClinicCleveland, Ohio
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- Huntsman Cancer Institute - University of UtahSalt Lake City, Utah