drugset / Trial / NCT06059001

Study to Evaluate the Safety, PK, and Efficacy of the Myc Inhibitor OMO-103 Administered iv in Patients With PDAC

NCT06059001 ↗

Phase 1 Active not recruiting 26 enrolled Peptomyc S.L.
NaSingle-groupOpen-labelTreatment

Summary

This study is an open-label, multicentre, Phase 1b trial designed to determine the safety, tolerability, efficacy, PK, pharmacodynamics (PD) and proof-of-concept of OMO-103 in combination with the standard regimen gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer who are treatment-naïve in the advanced disease setting.

Timeline

Start
2023-08-31
Primary completion
2026-05-31
Completion
2026-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject OMO-103 Protein / enzyme biologic — Intravenous
Background Gemcitabine Small molecule — Intravenous
Background Nab-paclitaxel Small molecule — Intravenous