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.
Inclusion Criteria (Phase 1 and Phase 2)
Mentally competent and able to understand and sign the ICF.
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.
Histologically or cytologically documented, locally advanced, or metastatic solid tumor.
Exclusion Criteria (Phase 1 and 2)
Medical Conditions
History of primary immune deficiency.
History of clinically significant autoimmune disease that has required intervention in the last 6 months. Consultation with the MM may inform the discussion of whether autoimmune disease is clinically significant.
Parallel
STX-003
Biological/VaccineSTX-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.
KEYTRUDA®
Biological/VaccinePembrolizumab (Keytruda USPI 2026) is a marketed PD-1 blocking humanized monoclonal IgG4 kappa antibody.
Incidence of TEAEs, SAEs, and DLTs
Occurrence of changes from baseline in patients' clinical safety laboratory values and vital signs to assess the safety and tolerability of STX-003.
Collection and analysis of changes in data from baseline of patients' safety laboratory values (chemistry, hematology, coagulation, complement (Bb \& C3a), urinalysis, and lipids). Vital signs will include Temperature: (degrees Fahrenheit) Pulse: (beats per minute) Respiratory rate: (breaths per minute) Blood pressure: (systolic and diastolic each reported in mmHg) Oxygen saturation by pulse oximetry: (percentage (SpO2, %))
Assessment of PK and PD in patients dosed with STX-003
Area under the concentration curve (AUC)
Number and nature of preliminary antitumor activity of STX-003 as monotherapy and in combination with Pembrolizumab.
Assessment of Tumor infiltrating lymphocytes
Tumor biopsies will be analyzed by immunohistochemistry to assess tumor-infiltrating lymphocytes (TILs) in the tumor microenvironment, including density of CD4 and CD8 positive cells and PD-L1 expression.
Objective Response Rate (ORR) in patients with advanced solid tumors.
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