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

Inclusion Criteria:

1. Male or female patients, 18 years of age or older who sign the ICF and arewilling and able to comply with the study protocol.

2. Histologically or cytologically proven pancreatic cancer (pancreatic ductaladenocarcinoma [PDAC]).

3. Patients have to be treatment naïve in the metastatic setting (neo-or adjuvanttreatment has to be finished at least six months before) and are suitable toreceive the standard regimen gemcitabine and nab-paclitaxel.

4. Patients must show a specific biomarker signature, which will be analysedbefore 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 anddocumented by computed tomography (CT) and/or magnetic resonance imaging (MRI).NOTE: Lesions to be used as measurable disease for the purpose of responseassessment must either:

6. not reside in a field that has been subjected to prior radiotherapy, or

7. have demonstrated clear evidence of radiographic progression since thecompletion of prior radiotherapy and prior to study enrolment.

8. Tumour biopsy (either from the primary tumour or from metastases) duringScreening 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 aparaffin block is available, a new biopsy does not need to be done atScreening.

9. For each patient undergoing pre- and on-treatment biopsies, the identifiedlesion to be biopsied should not have been previously irradiated andshould not be the only lesion being utilised as a measurable-diseasetarget lesion for objective response assessment. Patients must have tumourlesions that can be accessed for biopsy with acceptable clinical risk inthe judgement of the Investigator.

10. ECOG performance status up to 1. 9. Adequate organ function as defined bythe following criteria:Haematological:o Neutrophils ≥1,500/μLo Platelets ≥100,000/μL

• Haemoglobin ≥10 g/dLRenal:o Creatinine Clearance (calculated via Cockcroft-Gault Equation) ≥50 mL/minHepatic:o Serum total bilirubin ≤1.5 upper limit of normal (ULN) oro Direct bilirubin ≤ULN for patients with total bilirubin >1.5 ULNo 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 metastasesChemistry:
• Albumin >30 g/L. 10. If not postmenopausal or surgically sterile, femalepatients must be willing to practice at least one of the following highlyeffective methods of birth control (defined as having a low failure rate)for at least a menstrual cycle before and for 1 month after last studydrug administration:

1. True abstinence, when this is in line with the preferred and usual lifestyle ofthe patient, from sexual intercourse with a member of the opposite sex;

2. Sexual intercourse with vasectomised male;

3. Hormonal female contraceptive (oral, parenteral, intravaginal, implantable ortransdermal) for at least 3 consecutive months prior to investigational productadministration (when not clinically contraindicated as in breast, ovarian andendometrial cancers);

4. Use of an intrauterine contraceptive device. 11. Male patients and their sexualpartners must use an appropriate contraceptive from Screening for 6 monthsafter last study drug administration, including:

5. True abstinence

6. Male sterilisation

7. Hormonal female contraceptive (oral, parenteral, intravaginal, implantable ortransdermal) and condom

8. Intrauterine contraceptive device and condom.

Exclusion Criteria:

1. Systemic anti-cancer therapy within four weeks prior to study drug administration.

2. Radiation therapy within four weeks prior to study entry. Localised palliativeradiotherapy to non-target lesions is allowed.

3. Previous or concurrent malignancy that could affect compliance with the protocol orinterpretation of results. Patients curatively treated more than 2 years prior toenrolment, and patients with adequately treated basal cell or squamous cell skincancer, or carcinoma in situ are eligible.

4. Previous treatment with either gemcitabine or nab-paclitaxel in any setting.

5. Contraindication to receive gemcitabine/nab-paclitaxel.

6. Non-malignant systemic disease including cerebrovascular accident, unstable anginapectoris, unstable atrial fibrillation, unstable cardiac arrhythmia, myocardialinfarction in the last six months, New York Heart Association (NYHA) Class III or IVheart failure.

7. Patients with active uncontrolled infection or known to be serologically positivefor human immunodeficiency virus (HIV), hepatitis B (except after vaccination) orhepatitis C infection. Investigators may test as per their discretion.

8. Other severe acute or chronic medical or psychiatric condition or laboratoryabnormality that may increase the risk associated with study participation orinvestigational product administration or may interfere with the interpretation ofstudy results and, in the judgment of the Investigator, would make the patientinappropriate for entry into this study.

9. Pregnant or nursing.

10. Patients with symptomatic or unstable central nervous system primary tumour ormetastases and/or carcinomatous meningitis.

11. Live vaccine in the last four weeks.

12. Current participation in another trial.