Xilio Therapeutics has reported preliminary data from its Phase I clinical trial of XTX101 for the treatment of advanced solid tumours.
XTX101 is an investigational tumour-activated, Fc-enhanced anti-CTLA-4 which depletes regulatory T cells upon activation in the tumour microenvironment.
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The study has enrolled 25 patients with various advanced and treatment-refractory solid tumours including non-small cell lung cancer (NSCLC), colorectal cancer and pancreatic cancer.
Additionally, 76% of patients previously received treatment with at least three prior lines of anti-cancer therapy and 44% with at least one immuno-oncology agent.
Out of the total patients, 25 received XTX101 7mg to 180mg once every three weeks (Q3W) and 150mg once every six weeks (Q6W).
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Of these subjects, 20 were dosed in Part IA of monotherapy dose-escalation and five patients in Part IB of monotherapy dose-expansion.
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By GlobalDataThe study showed favourable preliminary safety, pharmacokinetic and pharmacodynamic data for XTX101.
Based on the data, a recommended Phase II dose (RP2D) of 150mg Q6W was determined. No dose-limiting toxicities and immune-related endocrine or skin adverse events were observed.
Xilio Therapeutics president and research and development head Martin Huber said: “Following treatment with XTX101 monotherapy at the recommended Phase II dose of 150mg once every six weeks, we observed a partial response in a patient with PD-L1 negative advanced non-small cell lung cancer.
“Importantly, this anti-tumour activity occurred in the absence of meaningful observed activation of the immune system in the periphery, suggesting tumour-selective activation of XTX101.
“Based on this Phase I data, we plan to explore opportunities to evaluate XTX101 in combination with an anti-PD-(L)1 in historically immunotherapy-resistant tumour types.”
