Study to Evaluate the Safety, PK, and Efficacy of the Myc Inhibitor OMO-103 Administered iv in Pa… (NCT06059001) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study to Evaluate the Safety, PK, and Efficacy of the Myc Inhibitor OMO-103 Administered iv in Patients With PDAC
Spain26 participantsStarted 2023-08-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Number of AEs, SAEs to evaluate the safety and tolerability of OMO-103 plus gemcitabine/nab-paclitaxel
Timeframe: through study completion, an average of 2 years
✕. 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.