P1, N=195, Active, not recruiting, Genentech, Inc. | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
7 days ago
Trial completion date • Trial primary completion date
P1, N=18, Completed, Masonic Cancer Center, University of Minnesota | Active, not recruiting --> Completed | Trial completion date: Feb 2026 --> Feb 2025
Single-cell RNAseq and flow cytometry data confirmed activation and infiltration of both innate and adaptive immune cells. ACTM-838 showed durable anti-tumor efficacy in multiple murine tumor models and synergized with anti-PD1 therapy in combination.
In this work, we develop a quantitative systems pharmacology (QSP) model to capture the dynamics of lymphocyte expansion in response to three engineered IL-15/IL-15Rα therapeutics: a potency engineered Fc-fusion referred to as Efbalropendekin alfa; a heterodimeric, PD-1 targeted cytokine assessed in non-clinical studies (PD1/IL15 TaCk); and an anti-respiratory syncytial virus targeted cytokine that serves as a non-binding isotype control (RSV/IL15 TaCk)...Finally, we leverage our QSP modeling framework to generate virtual cohorts with various translational scenarios to make clinical PK/PD predictions in response to PD1/IL15 TaCk treatment. Overall, the systems modeling presented herein offers a novel approach to integrate non-clinical datasets, aid in translation, and support dosing decisions for cytokine-based therapies that activate the immune system and display a dynamic PK/PD relationship.
These early-phase findings suggest that VG161 elicits meaningful immune activation in ICC and supports further investigation. By inducing both direct oncolysis and multilayered immune activation, VG161 shows clinical benefit in a heavily pretreated population and holds promise for integration with CPI-based regimens. Validation in larger trials is warranted.
2 months ago
Journal • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IL15 (Interleukin 15)
P1, N=18, Recruiting, UNC Lineberger Comprehensive Cancer Center | Trial completion date: Jun 2039 --> Jun 2044 | Trial primary completion date: May 2025 --> May 2030
3 months ago
Trial completion date • Trial primary completion date
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IL15 (Interleukin 15)
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cyclophosphamide • fludarabine IV • iC9.GD2.CAR.IL-15 T-cells