ArticleClinical cancer research : an official journal of the American Association for Cancer Research2026
Phase I Trial of Ipatasertib plus Atezolizumab Enhances PI3K/AKT Pathway Immune Responses in Solid Tumors and Refractory Glioblastoma.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03673787 (Ice-CAP), which is not on this map. Not yet cited in PubMed.
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Ice-CAP: A Phase I Trial of Ipatasertib in Combination With Atezolizumab in Patients With Advanced Solid Tumours With PI3K Pathway Hyperactivation
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41 authors.
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Abstract
purposeActivation of the phosphoinositide 3-kinase/AKT (PI3K/AKT) signaling pathway promotes tumor immune evasion by suppressing effector T-cell infiltration and enhancing regulatory T-cell (Treg) activity, contributing to resistance to immune checkpoint inhibitors (ICI). Preclinical studies have demonstrated that inhibition of this pathway can restore antitumor immunity and synergize with PD-1/PD-L1 blockade. We explore the synergistic clinical potential of targeting the PI3K/AKT pathway in combination with atezolizumab to overcome immunotherapy resistance in recurrent glioblastoma (GBM) and advanced solid tumors. PATIENTS AND
methodsPhase Ib, investigator-initiated, open-label study (NCT03673787) composed of a proof-of-concept dose escalation part A of ipatasertib plus atezolizumab in a 3 + 3 design. Adult patients with treatment-refractory advanced cancers were enrolled into cohort A1 and recurrent GBM into cohort A2. Part B enrolled patients into six exploratory cohorts. The study aims to evaluate the safety, immune-modulatory effects, and preliminary efficacy of the combination of ipatasertib with atezolizumab.
resultsThe combination was well tolerated, with no dose-limiting toxicities at the recommended phase II dose of ipatasertib 400 mg daily plus atezolizumab 1,200 mg every 3 weeks. Pharmacodynamic analysis demonstrated depletion of FOXP3+ Tregs and increased infiltration of CD8+ effector T cells within the tumor microenvironment (TME). Durable exceptional responses were seen in some patients with treatment-refractory or recurrent GBM.
conclusionsThis is the first report in clinical samples showing that ipatasertib efficiently depletes FOXP3+ Tregs and results in increased infiltration of effector CD8+ T cells in the TME. This was associated with preliminary efficacy in a subset of patients with treatment-refractory GBM.
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