French company Innate Pharma has completed patient enrolment in the dose escalation segment of the Phase I IPH4502-101 study, involving its Nectin-4 exatecan antibody-drug conjugate (ADC), IPH4502.
Preliminary dataset from 76 patients is anticipated to be available by the end of the year.
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These results are intended to inform dose optimisation in selected tumour types for the next stages of development.
The open-label, multi-centre trial is being carried out at sites in France and the US.
It is designed to examine the safety, tolerability and preliminary anti-tumour activity of IPH4502 as a single agent in patients with advanced solid tumours expressing Nectin-4.
Tumour types eligible for the study include, but are not limited to, non-small cell lung cancer (NSCLC), urothelial carcinoma (UC), and head and neck squamous cell carcinoma (HNSCC).
Till date, Innate Pharma has reported that the product has continued to show a favourable safety profile, with limited haematological toxicity.
The company has attributed this to its linker, which is designed for slow release of free exatecan, potentially reducing toxicity.
Objective responses have been reported in patients with advanced solid tumours who have previously received multiple treatments, including those with post-enfortumab vedotin UC, as well as NSCLC and HNSCC.
Innate Pharma EVPand chief medical officer Sonia Quaratino said: “Completing enrolment in the dose escalation marks an important milestone for IPH4502.
“The data generated to date continue to support the differentiated design of IPH4502, notably through the limited haematological toxicity observed to date, which we believe might reflect the benefits of our proprietary linker.”
IPH4502 combines a humanised anti-Nectin-4 antibody, a stable linker, and the exatecan payload, a topoisomerase I inhibitor.
In January 2025, Innate Pharma dosed the first patient in a Phase I trial of its ADC, IPH4502, which is designed to target tumours expressing Nectin-4.
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