The DOI matches its Crossref record; 7 of the 7 references it cites were found in a registry or an index.
Phase I study of MRX34, a liposomal miR-34a mimic, administered twice weekly in patients with advanced solid tumors
Open accessAbstract
SummaryPurpose Naturally occurring tumor suppressor microRNA-34a (miR-34a) downregulates the expression of >30 oncogenes across multiple oncogenic pathways, as well as genes involved in tumor immune evasion, but is lost or under-expressed in many malignancies. This first-in-human, phase I study assessed the maximum tolerated dose (MTD), safety, pharmacokinetics, and clinical activity of MRX34, a liposomal miR-34a mimic, in patients with advanced solid tumors. Patients and Methods Adult patients with solid tumors refractory to standard treatment were enrolled in a standard 3 + 3 dose escalation trial. MRX34 was given intravenously twice weekly (BIW) for three weeks in 4-week cycles. Results Forty-seven patients with various solid tumors, including hepatocellular carcinoma (HCC; n = 14), were enrolled. Median age was 60 years, median prior therapies was 4 (range, 1–12), and most were Caucasian (68%) and male (57%). Most common adverse events (AEs) included fever (all grade %/G3%: 64/2), fatigue (57/13), back pain (57/11), nausea (49/2), diarrhea (40/11), anorexia (36/4), and vomiting (34/4). Laboratory abnormalities included lymphopenia (G3%/G4%: 23/9), neutropenia (13/11), thrombocytopenia (17/0), increased AST (19/4), hyperglycemia (13/2), and hyponatremia (19/2). Dexamethasone premedication was required to manage infusion-related AEs. The MTD for non-HCC patients was 110 mg/m2, with two patients experiencing dose-limiting toxicities of G3 hypoxia and enteritis at 124 mg/m2. The half-life was >24 h, and Cmax and AUC increased with increasing dose. One patient with HCC achieved a prolonged confirmed PR lasting 48 weeks, and four patients experienced SD lasting ≥4 cycles. Conclusion MRX34 treatment with dexamethasone premedication was associated with acceptable safety and showed evidence of antitumor activity in a subset of patients with refractory advanced solid tumors. The MTD for the BIW schedule was 110 mg/m2 for non-HCC and 93 mg/m2 for HCC patients. Additional dose schedules of MRX34 have been explored to improve tolerability.
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Slack, F. J., & Chinnaiyan, A. M. (2019) · Cell · doi:10.1016/j.cell.2019.10.017 · Cited by 1,619
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Noncoding RNA therapeutics—Challenges and potential solutions
Winkle, M., El-Daly, S. M., Fabbri, M., & Calin, G. A. (2021) · Nature Reviews Drug Discovery · doi:10.1038/s41573-021-00219-z · Cited by 1,551
Epigenetics of colorectal cancer: biomarker and therapeutic potential
Jung, G., Hernández-Illán, E., Moreira, L., Balaguer, F., & Goel, A. (2020) · Nature Reviews Gastroenterology & Hepatology · doi:10.1038/s41575-019-0230-y · Cited by 813
Metadata
- Authors
- Beg, M. S., Brenner, A. J., Sachdev, J., Borad, M., Kang, Y.-K., Stoudemire, J., Smith, S., Bader, A. G., Kim, S., & Hong, D. S.
- Venue
- Investigational New Drugs
- Published
- 2016-12-05
- Volume
- 35
- Issue
- 2
- Pages
- 180-188
- ISSN
- 0167-6997 (ISSN-L)
- 1573-0646
- OpenAlex
- W2558790575
- Cited by
- 897
- References
- 7
- FWCI
- 31.30
- Type
- journal article
- Language
- en
- Open access
- green
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- Beg, M. S., Brenner, A. J., Sachdev, J., Borad, M., Kang, Y.-K., Stoudemire, J., Smith, S., Bader, A. G., Kim, S., & Hong, D. S. (2017). Phase I study of MRX34, a liposomal miR-34a mimic, administered twice weekly in patients with advanced solid tumors. Investigational New Drugs. https://doi.org/10.1007/s10637-016-0407-y
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