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Boundless Bio Advances New Breast Cancer Drug BBI-940 Into First-in-Human Trial

Boundless Bio Advances New Breast Cancer Drug BBI-940 Into First-in-Human Trial

Boundless Bio Inc. (BOLD) announced an update on their ongoing clinical study.

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Boundless Bio Inc. (BOLD) has launched a first-in-human Phase 1 trial called KOMODO-1 to test BBI-940 in adults with advanced or metastatic breast cancer. The study aims to find a safe dose, understand side effects, and look for early signs of benefit, which could open a new treatment path if results are positive.

The trial tests BBI-940, an oral drug designed to break down a protein called kinesin that helps cancer cells grow and divide. It is given alone or combined with fulvestrant, a standard hormone shot used in certain breast cancers, to see if the pairing improves outcomes.

The study is interventional and non-randomized, meaning all patients receive active treatment rather than placebo and are assigned to dose groups in sequence. It is open-label, so doctors and patients know which treatment is given, and the core goal is treatment-focused: to define dose, safety, and early activity signals.

The trial was first submitted on 2026-01-22 and is not yet recruiting, signaling that site setup and regulatory work are still underway. The latest update was filed on 2026-02-10, showing the protocol is current, though primary and final completion dates have not yet been posted and will be important future catalysts.

For investors, this update confirms Boundless Bio is moving another pipeline asset into the clinic, which can support the long-term story but will not shift near-term cash flows. As an early Phase 1 program in a crowded breast cancer space with players like Pfizer, Eli Lilly, and AstraZeneca, any influence on BOLD’s share price will likely hinge on safety and early response data rather than study start alone.

The KOMODO-1 study of BBI-940 in advanced breast cancer is now formally active in the planning phase and remains ongoing, with further details available on the ClinicalTrials portal.

To learn more about BOLD’s potential, visit the Boundless Bio Inc. drug pipeline page.

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