Company: NCNA
Filing Date: 2025-03-20
Form Type: 20-F
Source: 0000950170-25-042709
Chunk: 124

Company: NuCana plc
Filing Date: 2025-03-20
Form: 20-F
Item: Item 4
Chunk 124
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 in preclinical studies.
 

NUC-7738: Ongoing Phase 1/2 clinical trial (NuTide:701)
 NUC-7738 is in the Phase 2 part of a Phase 1/2 clinical trial (NuTide:701) which is evaluating NUC-7738 as a monotherapy in patients with advanced solid tumors and in combination with pembrolizumab in patients with melanoma. We presented data on the Phase 2 part of the clinical trial in the third quarter of 2024. The objective of the Phase 1 part of the trial was to establish the recommended dose and schedule for NUC-7738, as illustrated below. The objective of the Phase 2 part of the trial is to evaluate efficacy and further characterize the safety profile of NUC-7738 at the recommended Phase 2 dose both as a monotherapy and in combination with the PD-1 inhibitor, pembrolizumab.
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In September 2021, at ESMO, we presented interim data from the first 29 patients treated in this trial. These interim data indicated a favorable pharmacokinetic and tolerability profile of NUC-7738. In plasma samples from patients treated with NUC-7738, a dose-proportional increase in exposure was observed. NUC-7738 was efficiently converted to the active anti-cancer metabolite, 3’-dATP, in patients white blood cells, where high levels of 3’-dATP were detected. The intracellular 3’-dATP generated also had a prolonged half-life, with detectable levels in some patients more than 50 hours after infusion. NUC-7738 has been found to be well tolerated. Additionally, three case studies highlighted patients with encouraging tumor reductions who remained on NUC-7738 treatment for extended periods of time.
 In September 2022, we presented additional data from the Phase 1 part of NuTide:701 at ESMO. These data showed encouraging signals of anti-tumor activity across a range of tumor types, particularly melanoma. Promising data were observed in a variety of solid tumors with numerous patients staying on treatment for extended periods