Phase 2 test of QBS72S for breast cancer leptomeningeal disease
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ID: 324163
2026
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Abstract
BACKGROUND: Leptomeningeal disease (LMD) is a devastating complication of metastatic breast cancer that leads to severe neurologic symptoms and a poor prognosis. Current treatment options, including radiation and intrathecal chemotherapy, offer limited efficacy and are associated with significant toxicity. Generally, systemic therapy in LMD poorly penetrates the blood-brain barrier (BBB). Leveraging the L-type amino acid transporter 1 (LAT1) represents a unique therapeutic strategy, as LAT1 facilitates transport of medications across the BBB, and is also highly expressed in metastatic cancer cells. QBS72S is a first-in-class BBB-penetrant bifunctional molecule targeting overexpression of LAT1 to selectively eliminate cancer cells. It has shown preclinical efficacy in a mouse model of breast cancer LMD. METHODS: This Phase 2a, single-arm, open-label clinical trial (NCT05305365) investigated the safety, cerebrospinal fluid (CSF) concentration, pharmacokinetics, and preliminary efficacy of QBS72S in participants with breast cancer brain metastases. Secondary endpoints included progression-free survival, overall survival, and duration of response. Correlative analyses included LAT1 immunohistochemistry and CSF cell-free RNA sequencing. RESULTS: In this analysis, we report results from breast cancer patients with LMD (n = 10) treated with QBS72S. QBS72S was reliably detected in CSF, adequately tolerated, and two participants exhibited long-term radiographic stability or improvement lasting 6-7 months. CONCLUSIONS: These early findings support further investigation of QBS72S as a targeted therapy for LMD, addressing an urgent unmet need in metastatic breast cancer.
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| Authors | Seema Nagpal, Brandon Carlson-Clarke, Sahara S Rout, Thy T H Trinh, Meaghan Roy-O’Reilly, Sarah N. Tedjakusuma, Rukayat Taiwo, Paul M Harary, Monica Granucci, Sophia B. Chernikova, Sophie Bertrand, Kate E. Therkelsen, Summer S. Han, Bo Gu, Krishna L. Bharani, John M Newman, Giuseppe Barisano, Maxine Umeh-Garcia, D Herrick, Hannes Vogel, Mili Arora, Cynthia Harryman Samos, Scott G. Soltys, Erqi L. Pollom, Elham Rahimy, Michael Iv, Michelle Melisko, M. H. Gephart |
| Journal | journal of neuro-oncology |
| Year | 2026 |
| DOI |
10.1093/neuonc/noag177
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| URL | |
| Keywords | Keywords not found |
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