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Metastatic Pancreatic CancerPhase 1OMO-103-02NCT06059001

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

A Phase 1 study testing OMO-103, Nab-Paclitaxel and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Peptomyc S.L. at 6 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
OMO-103, Nab-Paclitaxel and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
6 sitesSpain
Study dates
31 Aug 2023to 31 May 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. 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.
  • 2. Histologically or cytologically proven pancreatic cancer (pancreatic ductal adenocarcinoma [PDAC]).
  • 3. 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.
  • 4. Patients must show a specific biomarker signature, which will be analysed before inclusion into the study, comprising CD62E, MIP-1ß, MCP-1 and IL-8.
  • 5. 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
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  • have demonstrated clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrolment.
  • 6. 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.
  • 7. 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.
  • 8. 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
  • Hepatic:
  • o Serum total bilirubin ≤1.5 upper limit of normal (ULN) or
  • o Direct bilirubin ≤ULN for patients with total bilirubin >1.5 ULN
  • o Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) ≤2.5 ULN or ≤5 ULN if liver metastases
  • Chemistry:
  • Albumin >30 g/L. 10. If not postmenopausal or surgically sterile, female patients must be willing to practice at least one of the following highly effective methods of birth control (defined as having a low failure rate) for at least a menstrual cycle before and for 1 month after last study drug administration:
  • <!-- -->
  • True abstinence, when this is in line with the preferred and usual lifestyle of the patient, from sexual intercourse with a member of the opposite sex;
  • Sexual intercourse with vasectomised male;
  • Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal) for at least 3 consecutive months prior to investigational product administration (when not clinically contraindicated as in breast, ovarian and endometrial cancers);
  • Use of an intrauterine contraceptive device. 11. Male patients and their sexual partners must use an appropriate contraceptive from Screening for 6 months after last study drug administration, including:
  • <!-- -->
  • True abstinence
  • Male sterilisation
  • Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal) and condom
  • Intrauterine contraceptive device and condom.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Spain6 sites

  • Hospital Vall d´Hebrón

    Barcelona, Barcelona, 08035

  • ICO Hopsitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Gregorio Marañon

    Madrid, Madrid, 28007

  • Hospital Regional Universitario de Málaga

    Málaga, Spain, 29010

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Miguel Servet

    Zaragoza, Zaragoza, 5009

Other trials in Spain

About this study

Official title: 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

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.

Read the 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

Being tested
OMO-103, Nab-Paclitaxel, Gemcitabine
Keywords
PDAC, Pancreatic cancer, metastatic
Medical subject headings
Pancreatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMO-103Drug

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

  • Nab-PaclitaxelDrug

    IV infusion - Standard of Care

  • GemcitabineDrug

    IV infusion - Standard of Care

Study groups in NCT06059001
Study groupRoleWhat they receive
Nab-Paclitaxel+Gemcitabine+OMO-103ExperimentalSoC Gemcitabine/Nab-Paclitaxel plus experimental OMO-103
Receives: Drug: OMO-103; Drug: Nab-Paclitaxel; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: through study completion, an average of 2 years

Secondary outcomes (7)

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

    ORR, PFS, DCR, TTP, TTR, and DOR assessed via RECIST v1.1 criteria.

    Measured: through study completion, an average of 2 years

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

    Predictive cytokine signature and its impact on efficacy (as above)

    Measured: through study completion, an average of 2 years

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

    Percentage of tumour burden change evaluated via 3D volumetric analysis of the total tumour burden.

    Measured: through study completion, an average of 2 years

  4. Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory

    Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory abnormalities.

    Measured: through study completion, an average of 2 years

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

    PK parameters of OMO-103 plus gemcitabine/nab-paclitaxel

    Measured: through study completion, an average of 2 years

  6. To assess the development of human ADAs to OMO-103.

    Incidence of ADAs to OMO-103

    Measured: through study completion, an average of 2 years

  7. To evaluate quality of life (QoL) in patients with metastatic pancreatic cancer

    Scores on the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) (version 3) and QLQ-PAN26 (EORTC PAN26)

    QLQ-PAN26: Scale with values from 1 to 4, where 4 is the most positive for the patient's quality of life.

    QLQ-C30: Scale with values from 1 to 4, where 1 is the most positive for the patient's quality of life.

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start31 Aug 2023
  3. Primary completion31 May 2026 (estimated)
  4. Study completion31 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06059001
Sponsor's protocol ID
OMO-103-02
Acronym
OMO-103-02
Status last verified
Jan 2026
First submitted
13 Sep 2023
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OMO-103, Nab-Paclitaxel and Gemcitabine in people with Metastatic Pancreatic Cancer, run by Peptomyc S.L. at 6 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of AEs, SAEs to evaluate the safety and tolerability of OMO-103 plus gemcitabine/nab-paclitaxel (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06059001.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.

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