IT MEDI1191 plus systemic anti-PD-L1 was safe and feasible. Preliminary antitumor efficacy and pharmacodynamics, including tumor CD8+ T cell recruitment, were consistent with expected mechanism of action. Pts with injectable deep visceral and superficial lesions are being recruited.
over 2 years ago
Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
Clinical trial identification NCT03946800. Conclusions Sequential combination of IT MEDI119 with IV durvalumab was well tolerated and showed encouraging preliminary antitumor and pharmacodynamic activity including in IO pre-treated pts, consistent with the expected mechanism of action. The study is active and recruiting.
Trial design This phase I, multicenter, open-label, dose-escalation (Part 1) and expansion (Part 2) study (NCT03946800) evaluates the safety and efficacy of MEDI1191 IT in sequential or concurrent combination with durvalumab 1500 mg Q4W IV. Funding: AstraZeneca. Clinical trial identification: NCT03946800.