Participant flow

NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours · Source last updated 2026-07-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase). NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.

   id

   FG000

   title

   Module 1 (NUC-3373 + LV + Pembrolizumab)

2. description

   This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic 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 (dose validation phase). NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level.

   id

   FG001

   title

   Module 2 (NUC-3373 + LV + Docetaxel)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         3

      type

      Progressive disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Not treated

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         4

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         4

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

This study was a modular Phase Ib/II study, with each module consisting of a Phase Ib dose-validation phase and a potential Phase II dose-expansion phase. However, the Phase II dose-expansion phase was not initiated in either module. All participants reported in the Participant Flow were enrolled in the Phase Ib part. Arms/groups were combined within each module because no participants were assigned to or treated in any Phase II expansion arm.

recruitment Details

A total of 26 patients were screened and 19 patients were enrolled across 3 sites in the UK between March 2023 and May 2025.

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Preserved source evidence · Not medical advice