NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours
| Condition | Advanced Cancer, Advanced Solid Tumor, Neoplasm Malignant, Metastatic Cancer |
|---|---|
| Phase | Phase 1/2 |
| Sponsor | NuCana plc |
| Status | Terminated |
| Enrollment | 19 participants |
| Interventions | Fosifloxuridine Nafalbenamide, Leucovorin, Pembrolizumab, Docetaxel |
| Start date | Mar 8, 2023 |
| Completion date | May 30, 2025 |
| Results posted | Jul 23, 2026 |
Summary
This study is an open-label, multi-arm, parallel cohort, dose validation and expansion design. The study is modular in design, allowing evaluation of the safety, efficacy and pharmacokinetics (PK) of NUC-3373 in combination with other agents for the treatment of patients with different tumour types. Each module is designed to evaluate a different NUC-3373 combination and consists of a dose-validation phase (Phase Ib) and a dose-expansion phase (Phase II). Phase Ib of each module will determine the safety and tolerability of the combinations for further clinical evaluation in Phase II. Approximately 6-20 evaluable patients will be enrolled in the Phase Ib stage of each module to determine safety, tolerability, and preliminary efficacy of NUC-3373 in combination with other agents. Each module will then move into Phase II to enable a further assessment of safety and efficacy in approximately 20-40 patients. Module 1 will assess NUC-3373 + leucovorin (LV) in combination with pembrolizumab for the treatment of patients with advanced/metastatic solid tumours who have progressed on ≤2 prior therapies for metastatic disease, that may have included 1 prior immunotherapy-containing regimen (
Number of Participants With DLTs in Each Module
| Module 1 (NUC-3373 + LV + Pembrolizumab) | 0 Participants |
|---|---|
| Module 2 (NUC-3373 + LV + Docetaxel) | 0 Participants |
Open in BENITIONS View on ClinicalTrials.gov
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