Drugs / Fosifloxuridine Nafalbenamide
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02723240 | Jan 2016 → Feb 2020 | cancer | University of Oxford | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05714553 | Mar 2023 → May 2025 | cancer of unknown primary site, carcinoma of esophagus, classic Hodgkin lymphoma, colorectal cancer +11 | NuCana plc | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03428958 | Oct 2018 → Mar 2024 | colorectal carcinoma | NuCana plc | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05678257 | Apr 2023 → Aug 2024 | colorectal adenocarcinoma | NuCana plc | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2025-10-14 | Nucana | Results NuCana Announces Encouraging Data for NUC-3373 in Combination with Anti-PD-1 Therapy nucana.com ↗
The update includes results from the NuTide:303 clinical study, published on medRxiv, the preprint server for health sciences, together with complementary preclinical findings published in the peer-reviewed journal Public Library of Science ONE (PLOS ONE). |
| 2024-11-11 | Nucana | Results NuCana Announces Encouraging Initial Data from Phase 1b/2 Modular Study of NUC-3373 in Combination with Pembrolizumab or Docetaxel nucana.com ↗
Encouraging signals of anti-cancer activity were observed with confirmed Partial Responses in 2 patients and Stable Disease in a further four patients, resulting in an objective response rate of 22% and a disease control rate of 67% in the efficacy evaluable population. |
| 2024-08-29 | Nucana | Results NuCana Announces Update for Phase 2 Randomized Colorectal Cancer Study nucana.com ↗
NuCana plc (NASDAQ: NCNA) announced that the NuTide:323 study is being discontinued following a pre-planned initial analysis and recommendation from the NuTide:323 Study Steering Committee. |
| 2023-10-13 | Nucana | Results NuCana Presents Encouraging Data on NUC-3373 in Colorectal Cancer at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2023 nucana.com ↗
Data presented today showed that both regimens had favorable tolerability profiles. |
| 2022-10-26 | Nucana | Results NuCana Presents Positive Data on NUC-3373 at the 34th EORTC-NCI-AACR Annual Meeting 2022 nucana.com ↗
NUC-3373 was shown to be a more potent inhibitor of TS than both pemetrexed and 5-FU. |
| 2022-09-12 | Nucana | Results NuCana Presents Favorable Data on NUC-3373 at the European Society of Medical Oncology (ESMO) Annual Meeting 2022 nucana.com ↗
Both NUFOX and NUFIRI demonstrated encouraging anti-tumor activity in heavily pre-treated CRC patients with progressive disease who had all previously received regimens containing 5-FU, oxaliplatin and irinotecan. |
| 2022-03-08 | Nucana | Results NuCana Announces Upcoming Presentations on NUC-3373 at the American Association for Cancer Research (AACR) Annual Meeting 2022 nucana.com ↗
NUC-3373 causes colorectal cancer (CRC) cell lines to release damage associated molecular patterns (DAMPs), molecular signals that can activate immune cells leading to immunogenic cell death (ICD). |
| 2022-03-02 | Nucana | Results NuCana Announces Update for Phase 3 Biliary Tract Cancer Study nucana.com ↗
The IDMC concluded that Acelarin plus cisplatin was unlikely to achieve its primary objective of demonstrating at least a 2.2-month improvement in overall survival as compared to the standard of care, gemcitabine plus cisplatin. |
| 2021-09-16 | Nucana | Results NuCana Announces Four Poster Presentations at the ESMO Congress 2021 nucana.com ↗
NUC-3373 Continues to Demonstrate Encouraging Efficacy Signals and a Favorable Safety Profile in Patients with Advanced Colorectal Cancer |
| 2021-04-10 | Nucana | Results NuCana Announces Five Poster Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2021 nucana.com ↗
In this difficult-to-treat group, who had received a median of four prior lines of therapy, NUC-3373, with or without leucovorin, demonstrated a 62% disease control rate (defined as stable disease lasting more than 8 weeks) in the efficacy-evaluable population. |
| 2021-01-15 | Nucana | Results NuCana Presents Encouraging Data at ASCO GI for NUC-3373 in Heavily Pre-Treated Patients with Metastatic Colorectal Cancer nucana.com ↗
NuCana plc (NASDAQ: NCNA) today announced interim data from the ongoing NuTide:302 study at the ASCO GI Conference, being held virtually January 15-17, 2021. |
| 2020-09-21 | Nucana | Results NuCana Presents Three Posters at the ESMO Virtual Congress 2020 nucana.com ↗
Data from the ongoing Phase Ib study (NuTide:302) in heavily pre-treated patients with metastatic colorectal cancer demonstrated NUC-3373’s favorable pharmacokinetic and tolerability profile was unaffected by leucovorin. |
| 2020-05-15 | Nucana | Results NuCana to Present Two Abstracts at the American Association for Cancer Research (AACR) Annual Meeting 2020 nucana.com ↗
The recent in vitro studies have shown NUC-3373 is able to not only damage DNA, but also induce endoplasmic reticulum stress, and the subsequent release of DAMPs. |
| 2019-10-29 | Nucana | Results NuCana Presents Data at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics nucana.com ↗
NuCana presented interim data from the Phase Ib NuTide:302 study in patients with advanced colorectal cancer confirming the previously reported favorable pharmacokinetic profile of NUC-3373. |
| 2019-08-20 | Nucana | Results Enrollment in the Independent Investigator-Sponsored Phase III Metastatic Pancreatic Study ACELARATE Has Been Suspended Following a Prespecified Futility Analysis nucana.com ↗
This analysis indicated that this efficacy objective was unlikely to be met in this difficult to treat patient population. |
| 2019-02-27 | Nucana | Results NuCana to Present at the American Association for Cancer Research (AACR) Annual Meeting 2019 nucana.com ↗
The scientific findings from these non-clinical studies demonstrate that NUC-3373 has an additional mechanism of action for promoting anti-cancer activity that is independent of the DNA damage pathway. |
| 2018-10-22 | Nucana | Results NuCana Presents Data from Phase I Study of NUC-3373 at ESMO 2018 nucana.com ↗
Notably, three patients achieved Stable Disease after treatment, with responses lasting more than nine months at the time of data cutoff on September 25, 2018: |
| 2017-09-13 | Nucana | Results NuCana Announces Interim Data from First-In-Human Study of Transformative Anti-Cancer Agent, NUC-3373 nucana.com ↗
NuCana plc announced the presentation of interim first-in-human data from a Phase 1 clinical study of NUC-3373, its ProTide transformation of the active anti-cancer metabolite of 5-fluorouracil (5-FU), at the European Society for Medical Oncology (ESMO) 2017 Congress held earlier this week in Madrid, Spain. |
All press releases naming this drug 19 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fosifloxuridine Nafalbenamide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05714553 ↗ |
| Known as | CPF-373 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2181367 ↗ |
| Known as | Fosifloxuridina nafalbenamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL2181367 ↗ |
| Known as | NUC-3073 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2181367 ↗ |
| Known as | NUC-3373 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03428958 ↗ |
| Action | Inhibit | “NUC-3373, a targeted thymidylate synthase inhibitor” PMID 38566164 ↗ Apr 2024 |
| Modality | Small molecule | “NUC-3373 (a pyrimidine nucleotide analogue)” NCT02723240 ↗ |
| Route | Intravenous | “administered weekly or fortnightly as an I.V. (intravenous) infusion” NCT02723240 ↗ |
| Target | TYMS | “NUC-3373, a targeted thymidylate synthase inhibitor” PMID 38566164 ↗ Apr 2024 |