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

NCT06059001 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-01-14

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Peptomyc S.L.

    lead INDUSTRY

Principal Investigators

  • Teresa Macarulla, MD, PhD · Hospital Vall d´Hebrón

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06059001 on ClinicalTrials.gov