ESTRO 2024 - Abstract Book

S1299

Clinical - Head & neck

ESTRO 2024

Results:

Two patients treated with 0.92mg/ml NG11-2 and two patients treated with 1.84mg/ml NG11-2 have completed at least 6 weeks each of RT with/without concomitant CT, with daily administration of NG11-2 mouthwash prior to each fraction of RT. Good safety and tolerability profiles have been observed in all four patients, with no accumulative systemic adverse effects observed to date. The readouts of the primary and secondary end points for all four patients are reported individually. A preliminary dose-dependent effectiveness of NG11-2 on the prevention/delay of onset of Grade 3 OM has been observed in the dose escalation cohorts treated to date. Further escalation at dose levels of 3.66mg/ml and 5.5mg/ml are ongoing, the additional results are expected by April 2024.

Conclusion:

This current study provides safety and preliminary efficacy evidence so far to support the decision on the RP2D. After the dose escalation, a final expansion phase will be carried out at the selected RP2D level to supply additional insight into the characteristics of HNC patient cohorts and the pharmaceutical effect of NG11-2.

Keywords: Radiation-induced oral mucositis, NG11-2, Phase Ib

References:

Revathi Ananthakrishnan et al : Systematic comparison of the statistical operating characteristics of various Phase I oncology designs; Contemporary Clinical Trials Communications 5 (2017) 34e48

Brouwer et al; CT-based delineation of organs at risk in the head and neck region: DAHANCA, EORTC, GORTEC, HKNPCSG, NCIC CTG, NCRI, NRG Oncology and TROG consensus guidelines Radiotherapy and Oncology 117 (2015) 83 – 90 Li NF, Fahl WE. Reduction of Oral Mucositis Severity Using a Topical Vasoconstrictor in Bone Marrow Transplant Patients. New Frontiers in Medicine and Medical Research. 2022 Vol 10, Chapter 6, p47-55. Print ISBN: 978-93 91882-05-1, eBook ISBN: 978-93-91882-94-5

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