A Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Antitumor Activity of STX-003 Delivered Intravenously 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-003 Delivered by Intravenous Injection in Patients with Advanced Solid Tumors as a Monotherapy or in Combination with Pembrolizumab.
Description
This open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and dose expansion study involves STX-003 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. (Update after review)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Inclusion Criteria (Phase 1 and Phase 2) 1. Mentally competent and able to understand and sign the ICF. 2. Tumor type for which there is an FDA-approved anti-PD-1/L1 antibody therapy, specifically including biomarker labeled subsets (i.e. PD-L1+) as well as anatomical subsets in some disease (cutaneous melanoma is eligible whereas acral, mucosal and uveal are not; Phase 1) and advanced cutaneous melanoma or PD-L1+ NSCLC. 3. Histologically or cytologically documented, locally advanced, or metastatic solid tumor. 4. At least one measurable lesion per RECIST v1.1 c…
Interventions
- BiologicalSTX-003
STX-003 is a LNP formulated self-replicating mRNA encoding the therapeutic payload human IL-12 (hIL-12) with miRNA target sites to sense specific endogenous miRs.
- BiologicalKEYTRUDA®
Pembrolizumab (Keytruda USPI 2026) is a marketed PD-1 blocking humanized monoclonal IgG4 kappa antibody.
Locations (2)
- HonorHealth Research InstituteScottsdale, Arizona
- Sarah Cannon Research InstituteNashville, Tennessee