Repare Therapeutics has dosed the first subject in the non-small cell lung cancer (NSCLC) expansion of its Phase I/II TRESR clinical trial analysing camonsertib.
The open-label, multicentre TRESR trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumour activity of camonsertib both as a monotherapy and in combination with other treatments.
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It will also have dose-escalation and expansion segments.
This NSCLC expansion is set to recruit up to 20 patients who have ATR-inhibitor- sensitising mutations.
Its focus is to assess the efficacy of camonsertib at the recommended Phase II dose.
For patients with recurrent NSCLC, for which treatment options are limited, camonsertib presents an attractive oral therapy alternative with a well-established safety profile.
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By GlobalDataRepare Therapeutics anticipates reporting trial data from the camonsertib monotherapy NSCLC expansion in 2025.
The company leverages its genome-wide, CRISPR [clustered regularly interspaced short palindromic repeats]-enabled SNIPRx discovery platform to systematically identify and advance highly targeted cancer treatments focused on genomic instability and DNA damage repair.
Its pipeline includes other promising therapies such as lunresertib, currently in Phase I/II clinical development.
RP-1664 and RP-3467 and other undisclosed preclinical programmes form part of the portfolio.
Repare Therapeutics executive vice-president and chief medical officer Maria Koehler stated: “Camonsertib has demonstrated a promising signal of prolonged progression-free survival in patients with ATM-mutated NSCLC in our ongoing TRESR clinical trial. We are thrilled with the rapid and efficient expansion of this clinical trial with the treatment of the first patient less than one month from the return of camonsertib global rights to Repare.
“Our biomarker-driven approach with camonsertib monotherapy has the potential to address the high unmet need of over 5,000 patients with ATM-mutated NSCLC in the tumour recurrence setting, across the US, UK and top four EU markets, where unfortunately, the current standard of care provides progression-free survival of approximately four months and low response rates.”
