Evaluating a new treatment for metastatic pancreatic cancer
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 testing a new treatment combining OMO-103 with standard drugs for people who are newly diagnosed with metastatic pancreatic cancer to see if it is safe and effective.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peptomyc S.L. Industry-sponsored |
| Drugs / interventions | Radiation |
| Locations | 6 sites (L´Hospitalet de Llobregat, Barcelona and 5 other locations) |
| Trial ID | NCT06059001 on ClinicalTrials.gov |
What this trial studies
This open-label, multicentre Phase 1b trial aims to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of OMO-103 when combined with the standard treatment of gemcitabine and nab-paclitaxel in treatment-naïve patients with metastatic pancreatic cancer. The study consists of two parts: the first part focuses on determining the appropriate dosing and safety of the combination therapy, while the second part expands on this by further evaluating its efficacy and safety in a larger patient group. Patients will be closely monitored for their response to the treatment and any adverse effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed pancreatic ductal adenocarcinoma who are treatment-naïve and meet specific biomarker criteria.
Not a fit: Patients who have previously received treatment for pancreatic cancer or do not meet the biomarker signature requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with metastatic pancreatic cancer, potentially improving survival rates and quality of life.
How similar studies have performed: While this approach is novel in its specific combination, similar studies have shown promise in targeting pancreatic cancer with innovative therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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:
1. not reside in a field that has been subjected to prior radiotherapy, or
2. 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:
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1. 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;
2. Sexual intercourse with vasectomised male;
3. 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);
4. 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:
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1. True abstinence
2. Male sterilisation
3. Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal) and condom
4. 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 palliative radiotherapy to non-target lesions is allowed.
3. 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.
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 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.
7. 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.
8. 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.
9. Pregnant or nursing.
10. Patients with symptomatic or unstable central nervous system primary tumour or metastases and/or carcinomatous meningitis.
11. Live vaccine in the last four weeks.
12. Current participation in another trial.
Where this trial is running
L´Hospitalet de Llobregat, Barcelona and 5 other locations
- ICO Hopsitalet — L´Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
- Hospital Vall d´Hebrón — Barcelona, Spain (Recruiting)
- Hospital Gregorio Marañon — Madrid, Spain (Recruiting)
- Hospital Regional Universitario de Málaga — Málaga, Spain (Recruiting)
- Hospital Universitario Marqués de Valdecilla — Santander, Spain (Recruiting)
- Hospital Miguel Servet — Zaragoza, Spain (Recruiting)
Study contacts
- Principal investigator: Teresa Macarulla, MD, PhD — Hospital Vall d´Hebrón
- Study coordinator: Manuela Niewel, MD, PhD
- Email: mniewel@peptomyc.com
- Phone: +34670327414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.