NCT05714553

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

A Phase Ib/II Open Label, Multi-arm, Parallel Cohort Dose Finding and Expansion Study to Assess the Safety, Pharmacokinetics and Efficacy of NUC-3373, a Nucleotide Analogue, Given in Combination With Standard Approved Agents in Patients With Advanced Solid Tumours

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: NuCana plc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Fosifloxuridine Nafalbenamide	Intravenous infusion
DRUG	Leucovorin	Intravenous infusion
DRUG	Pembrolizumab	Intravenous infusion
DRUG	Docetaxel	Intravenous infusion

Timeline

• Start date: 2023-03-08
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2023-02-06
• Last updated: 2025-07-18

Locations

4 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study