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

ABSTRACT: 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.

DISEASE(S): Carcinoma,Triple Negative Breast Neoplasms,Non Small Cell Lung Cancer,Mesothelioma,Urothelial Carcinoma,Triple Negative Breast Cancer,Msi-h Colorectal Cancer,Endometrial Neoplasms,Oesophageal Carcinoma,Neoplasms,Esophageal Neoplasms,Pleural Mesothelioma,Classical Hodgkin Lymphoma,Gastric Cancer,Advanced Solid Tumor,Renal Cell Carcinoma,Head And Neck Squamous Cell Carcinoma,Melanoma,Advanced Cancer,Neoplasm Malignant,Carcinoma, Squamous Cell,Squamous Cell Carcinoma Of Head And Neck,Subungual Squamous Cell Carcinoma,Metastatic Cancer,Endometrial Carcinoma

PROVIDER: 7300 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR