NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours
Status:
Not yet recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
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 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-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.