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Fosifloxuridine Nafalbenamide

NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours

Ensayo de NuCana plc en Advanced Cancer · Advanced Solid Tumor · Neoplasm Malignant · Metastatic Cancer · Melanoma · Classical Hodgkin Lymphoma · Non Small Cell Lung Cancer · Renal Cell Carcinoma · Urothelial Carcinoma · Head and Neck Squamous Cell Carcinoma · Subungual Squamous Cell Carcinoma · Oesophageal Carcinoma · MSI-H Colorectal Cancer · Gastric Cancer · Triple Negative Breast Cancer · Endometrial Carcinoma · Pleural Mesothelioma (del registro, en inglés).

Más ensayos de: Cáncer avanzado · Tumor sólido avanzado · Cáncer metastásico · Melanoma · Cáncer de pulmón no microcítico · Carcinoma de células renales · Carcinoma urotelial · Carcinoma escamoso de cabeza y cuello · Cáncer gástrico · Cáncer de mama triple negativo · Cáncer de endometrio.

Fase

Fase 1/2

Estado

Interrumpido

Participantes

19

previstos

Centros

4

Fin del objetivo primario

may 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en mar 2023.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The NuTide:303 study was terminated at NuCana's discretion following refinement of the NUC-3373 development strategy.».

Qué mide

Number of Participants With DLTs in Each Module (Assessed during Cycle 1 (first 28 days) in Module 1 and during Cycles 1 and 2 (first 56 days) in Module 2) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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 (either monotherapy or in combination with chemotherapy) or who have not progressed but where addition of NUC-3373 + LV to standard pembrolizumab monotherapy may be appropriate (e.g., patients who could not tolerate post- immuno-oncology (IO) standard of care therapy). Module 2 will assess NUC-3373 + LV in combination with docetaxel for the treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC) or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease. The opening of each module will be at the discretion of the Sponsor. Further modules may be added as non-clinical and clinical data become available to support additional NUC-3373 combinations and tumour types.

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Todos los de NCNA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05714553), actualizada en jul 2026.