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.
≥ 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.
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.
Parallel
STX-001
Biological/VaccineSTX-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.
Keytruda®
Biological/VaccinePembrolizumab (Keytruda USPI 2023) is a marketed PD-1 blocking humanized monoclonal IgG4 kappa antibody.
Number and nature of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients with advanced solid tumors.
The occurrence of DLTs, TEAEs, and SAEs will be used to determine the maximum tolerated dose and recommended Phase 2 dose of STX-001.
Occurrence of changes from baseline in patients' clinical safety laboratory values and vital signs to assess the safety and tolerability of STX-001.
Collection and analysis of changes in data from baseline of patients' vital signs (temperature, pulse, respiratory rate, blood pressure, oxygen saturation via pulse oximetry) as well as clinical safety laboratory values (chemistry, hematology, coagulation, complement (Bb \& C3a), urinalysis, and lipids).
Assessment of PK in patients dosed with STX-001
Individual and mean plasma STX-001 concentrations versus time data will be collected, summarized, and plotted by dose level.
Assessment of Tumor infiltrating lymphocytes (TILs)
Assessment of STX-001 PK concentrations in mono therapy and safety and tolerability of STX-001 in combination with pembrolizumab in the tumor microenvironment (biopsy).
Number and nature of preliminary antitumor activity of STX-001.
Proportion of patients with objective response rate (ORR), complete response (CR), or partial response (PR) per RECIST 1.1.
Number and nature of preliminary antitumor activity of STX-001 in combination with pembrolizumab.
Proportion of patients with objective response rate (ORR), disease control rate (DCR), complete response (CR), partial response (PR) or stable disease (SD) per RECIST 1.1.
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