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

NCT06059001 | Active Not Recruiting Phase 1

• 1 other identifier: OMO-103-02
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 6

Brief 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

Metastatic Pancreatic Cancer

Keywords

PDAC; Pancreatic cancer; metastatic

Outcome Measures

Primary Outcomes (1)

• Number of AEs, SAEs to evaluate the safety and tolerability of OMO-103 plus gemcitabine/nab-paclitaxel

  To evaluate the safety and tolerability of OMO-103 plus gemcitabine/nab-paclitaxel in adult patients with metastatic pancreatic cancer being treatment naïve.

  through study completion, an average of 2 years

Secondary Outcomes (7)

• To assess the anti-tumour activity of OMO-103 plus gemcitabine/nab-paclitaxel as measured by objective response rate (ORR)

  through study completion, an average of 2 years

• Ratio of patients with positive cytokine predictive signature result and its impact on efficacy

  through study completion, an average of 2 years

• To assess the anti-tumour activity via 3D-volumetric measurement

  through study completion, an average of 2 years

• Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory

  through study completion, an average of 2 years

• To characterise the PK of OMO-103 plus gemcitabine/nab-paclitaxel

  through study completion, an average of 2 years

Study Arms (1)

Nab-Paclitaxel+Gemcitabine+OMO-103

EXPERIMENTAL

SoC Gemcitabine/Nab-Paclitaxel plus experimental OMO-103

Drug: OMO-103; Drug: Nab-Paclitaxel; Drug: Gemcitabine

Interventions

OMO-103 DRUG

Investigational Product: 35 mg/mL (4.5 mL/vial) concentrate for solution for infusion

Nab-Paclitaxel+Gemcitabine+OMO-103

Nab-Paclitaxel DRUG

IV infusion - Standard of Care

Nab-Paclitaxel+Gemcitabine+OMO-103

Gemcitabine DRUG

IV infusion - Standard of Care

Nab-Paclitaxel+Gemcitabine+OMO-103

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female patients, 18 years of age or older who sign the ICF and are willing and able to comply with the study protocol.
• \. Histologically or cytologically proven pancreatic cancer (pancreatic ductal adenocarcinoma \[PDAC\]).
• \. Patients have to be treatment naïve in the metastatic setting (neo-or adjuvant treatment has to be finished at least six months before) and are suitable to receive the standard regimen gemcitabine and nab-paclitaxel.
• \. Patients must have measurable disease as per RECIST v1.1 criteria and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI). NOTE: Lesions to be used as measurable disease for the purpose of response assessment must either:
• not reside in a field that has been subjected to prior radiotherapy, or
• have demonstrated clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrolment.
• \. Tumour biopsy (either from the primary tumour or from metastases) during Screening and during Treatment should be obtained from the patients. NOTE: In case a patient has had a tumour biopsy in the previous 6 months and a paraffin block is available, a new biopsy does not need to be done at Screening.
• \. For each patient undergoing pre- and on-treatment biopsies, the identified lesion to be biopsied should not have been previously irradiated and should not be the only lesion being utilised as a measurable-disease target lesion for objective response assessment. Patients must have tumour lesions that can be accessed for biopsy with acceptable clinical risk in the judgement of the Investigator.
• \. ECOG performance status up to 1. 9. Adequate organ function as defined by the following criteria:
• Haematological:
• o Neutrophils ≥1,500/μL
• o Platelets ≥100,000/μL
• Haemoglobin ≥10 g/dL
• Renal:
• o Creatinine Clearance (calculated via Cockcroft-Gault Equation) ≥50 mL/min

You may not qualify if:

• Systemic anti-cancer therapy within four weeks prior to study drug administration.
• Radiation therapy within four weeks prior to study entry. Localised palliative radiotherapy to non-target lesions is allowed.
• Previous or concurrent malignancy that could affect compliance with the protocol or interpretation of results. Patients curatively treated more than 2 years prior to enrolment, and patients with adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ are eligible.
• Previous treatment with either gemcitabine or nab-paclitaxel in any setting.
• Contraindication to receive gemcitabine/nab-paclitaxel.
• Non-malignant systemic disease including cerebrovascular accident, unstable angina pectoris, unstable atrial fibrillation, unstable cardiac arrhythmia, myocardial infarction in the last six months, New York Heart Association (NYHA) Class III or IV heart failure.
• Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except after vaccination) or hepatitis C infection. Investigators may test as per their discretion.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
• Pregnant or nursing.
• Patients with symptomatic or unstable central nervous system primary tumour or metastases and/or carcinomatous meningitis.
• Live vaccine in the last four weeks.
• Current participation in another trial.

Sponsors & Collaborators

• Peptomyc S.L.: lead

Study Sites (6)

Hospital Vall d´Hebrón

Barcelona, Barcelona, 08035, Spain

Location

ICO Hopsitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Gregorio Marañon

Madrid, Madrid, 28007, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, Spain, 29010, Spain

Location

Hospital Miguel Servet

Zaragoza, Zaragoza, 5009, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Teresa Macarulla, MD, PhD

  Hospital Vall d´Hebrón

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 28, 2023
• Study Start: August 31, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)