The DOI matches its Crossref record; 8 of the 8 references it cites were found in a registry or an index.
Phase 1 study of MRX34, a liposomal miR-34a mimic, in patients with advanced solid tumours
Open accessAbstract
BACKGROUND: In this first-in-human, Phase 1 study of a microRNA-based cancer therapy, the recommended Phase 2 dose (RP2D) of MRX34, a liposomal mimic of microRNA-34a (miR-34a), was determined and evaluated in patients with advanced solid tumours. METHODS: Adults with various solid tumours refractory to standard treatments were enrolled in 3 + 3 dose-escalation cohorts and, following RP2D determination, expansion cohorts. MRX34, with oral dexamethasone premedication, was given intravenously daily for 5 days in 3-week cycles. RESULTS: for non-HCC cancers. Pharmacodynamic results showed delivery of miR-34a to tumours, and dose-dependent modulation of target gene expression in white blood cells. Three patients had PRs and 16 had SD lasting ≥4 cycles (median, 19 weeks, range, 11-55). CONCLUSION: MRX34 treatment with dexamethasone premedication demonstrated a manageable toxicity profile in most patients and some clinical activity. Although the trial was closed early due to serious immune-mediated AEs that resulted in four patient deaths, dose-dependent modulation of relevant target genes provides proof-of-concept for miRNA-based cancer therapy. CLINICAL TRIAL REGISTRATION: NCT01829971.
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Metadata
- Authors
- Hong, D. S., Kang, Y.-K., Borad, M., Sachdev, J., Ejadi, S., Lim, H. Y., Brenner, A. J., Park, K., Lee, J.-L., Kim, T.-Y., Shin, S., Becerra, C. R., Falchook, G., Stoudemire, J., Martin, D., Kelnar, K., Peltier, H., Bonato, V., Bader, A. G., Smith, S., Kim, S., O’Neill, V., & Beg, M. S.
- Venue
- British Journal of Cancer
- Published
- 2020-04-02
- Volume
- 122
- Issue
- 11
- Pages
- 1630-1637
- ISSN
- 0007-0920 (ISSN-L)
- 1532-1827
- OpenAlex
- W3015098352
- Cited by
- 975
- References
- 8
- FWCI
- 31.35
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- The paper
- Hong, D. S., Kang, Y.-K., Borad, M., Sachdev, J., Ejadi, S., Lim, H. Y., Brenner, A. J., Park, K., Lee, J.-L., Kim, T.-Y., Shin, S., Becerra, C. R., Falchook, G., Stoudemire, J., Martin, D., Kelnar, K., Peltier, H., Bonato, V., Bader, A. G., . . . Beg, M. S. (2020). Phase 1 study of MRX34, a liposomal miR-34a mimic, in patients with advanced solid tumours. British Journal of Cancer. https://doi.org/10.1038/s41416-020-0802-1
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