NCT02723240

NUC-3373 in Advanced Solid Tumours

A Two-part, Phase I Open Label, Dose Escalation and Expansion Study to Assess Safety, Pharmacokinetics and Clinical Activity of NUC-3373, a Nucleotide Analogue, in Participants With Advanced Solid Tumours

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A two-part, phase I open label, dose escalation and expansion study to assess safety, pharmacokinetics and clinical activity of NUC-3373, a nucleotide analogue, in participants with advanced solid tumours.

Detailed description

This is a two-part, Phase I dose escalation study of NUC-3373 (a pyrimidine nucleotide analogue) as a single agent, administered weekly or fortnightly as an I.V. (intravenous) infusion. In both parts participants will undergo evaluations of the safety, PK (pharmacokinetics), PD (pharmacodynamics) and anti-tumour efficacy of NUC-3373 • Participants may continue to receive NUC-3373 until disease progression or unacceptable toxicity occurs. Part 1: Establish the RP2D (recommended phase two dose) and assess the safety and tolerability for single agent NUC-3373 administered as an I.V. infusion on day 1, 8, 15, 22 of a 28-day cycle. Participants can remain on study and receive treatment until disease progression or unacceptable toxicity occurs. The RP2D will be determined by dose escalation with sequential participants receiving increasing doses of NUC-3373 in a standard '3 + 3' cohort design. Part 2: Establish the RP2D and assess the safety and tolerability for single agent NUC-3373 administered as a fortnightly I.V. infusion on day 1 and 15 of a 28-day cycle. Participants can remain on study and receive treatment until disease progression or unacceptable toxicity occurs. The RP2D will be determined by dose escalation with sequential participants receiving increasing doses of NUC-3373 in a standard '3 + 3' cohort design. Finally, to assess preliminary efficacy signals and further characterise the safety profile, expansion cohorts of up to 20 additional participants per cohort will receive the RP2D of NUC-3373 as determined in Part 1 and Part 2 of the study. Participants can remain on study and receive treatment until disease progression or unacceptable toxicity occurs.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	NUC-3373

Timeline

• Start date: 2016-01-01
• Primary completion: 2020-02-24
• Completion: 2021-02-24
• First posted: 2016-03-30
• Last updated: 2024-02-14

Locations

3 sites across 1 country: United Kingdom