Part I dose escalation portion of the trial will assess BBI-825 as monotherapy in subjects with solid tumours. Credit: Kateryna Kon / Shutterstock.com.

Boundless Bio has dosed the first subject in the Phase I/II STARMAP clinical trial of BBI-825 aimed at treating individuals with locally advanced or metastatic cancer exhibiting resistance gene amplifications.

The STARMAP trial is an open-label, first-in-human, non-randomised study divided into three parts.

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It is designed to assess the safety, pharmacokinetics, pharmacodynamic biomarkers, and initial antitumour activity of BBI-825.

The trial will also establish the maximum tolerated dose and recommended Phase II dose (RP2D) when administered alone or along with targeted therapies.

Its Part I dose-escalation portion will assess BBI-825 as monotherapy in subjects with solid tumours.

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Part II will explore a combination dose escalation of BBI-825 with targeted therapies, specifically encorafenib and cetuximab, or adagrasib and cetuximab for colorectal cancer with BRAFV600E mutations.

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The targeted therapies will be given along with BBI-825 for those with kirsten rat sarcoma glycine-to-cysteine mutation at codon 12 (KRASG12C) mutations.

All of these subjects should have co-occurring resistance gene amplifications.

The Part III combination dose expansion portion will assess the preliminary anti-tumour activity at the RP2D of BBI-825 when combined with the targeted therapy pairings from Part II.

BBI-825 is the second extrachromosomal DNA (ecDNA)-directed therapy (ecDTx) of Boundless Bio to enter clinical trials.

As a selective, oral small molecule inhibitor of ribonucleotide reductase (RNR), BBI-825 targets a key enzyme responsible for the synthesis of DNA building blocks.

Boundless Bio has detected a crucial role for RNR in ecDNA assembly and repair, as well as in the survival of cancer cells with amplified oncogenes.

Boundless Bio president and CEO Zachary Hornby said: “Advancing our second ecDTx into clinical development is an important milestone for Boundless Bio and underscores the power of our Spyglass platform to identify synthetic lethal targets essential to ecDNA formation and function in oncogene amplified cancers.

“We are excited to enrol patients in this first-in-human Phase I/II study, focused initially on patients with KRASᴳ¹²ᶜ and BRAFⱽ⁶⁰⁰ᴱ mutated colorectal cancer with resistance gene amplifications.

“If data are supportive, we may have the opportunity to expand into broader patient populations, including pan-tumour, pan-RAS, and pan-RAF indications, potentially addressing these populations of cancer patients with very high unmet need.”