NCT06059001

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

A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients With Advanced Solid Tumours

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Peptomyc S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The study consists of two parts: Part 1 (Safety-Run-In) in patients with metastatic pancreatic cancer, evaluating OMO-103 plus gemcitabine/nab-paclitaxel in two dose levels at 75% and 100% of the RP2D. Approximately six patients will be enrolled in Part 1, covering two dose levels with the primary objective of determining the safety and tolerability of OMO-103 plus gemcitabine/nab-paclitaxel and defining an appropriate dose for further evaluation in Part 2. Part 2 (Dose expansion) in patients with metastatic pancreatic cancer where gemcitabine/nab-paclitaxel is a suitable treatment option. Patients will be treated with the dose found in part 1 to further characterise the safety, tolerability, PK, PD and anti-tumour activity of this combination

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	OMO-103	Investigational Product: 35 mg/mL (4.5 mL/vial) concentrate for solution for infusion
DRUG	Nab-Paclitaxel	IV infusion - Standard of Care
DRUG	Gemcitabine	IV infusion - Standard of Care

Timeline

• Start date: 2023-08-31
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2023-09-28
• Last updated: 2026-01-14

Locations

6 sites across 1 country: Spain