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New treatment option for Locally Advanced Pancreatic Ductal Adenocarcinoma
Official title OMO-103 for the Treatment of Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
ClinicalTrials.gov ID: NCT07089940
What this study is testing
What is Myc Inhibitor OMO-103?
Myc Inhibitor OMO-103 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced pancreatic ductal adenocarcinoma.
Also referred to as OMO 103, OMO-103.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This early phase I trial studies the biological activity of OMO-103 in patients with pancreatic ductal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). OMO-103 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must provide written informed consent before any study-specific procedures or interventions are performed
- Must be ≥ 18 years old at the time of informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Clinically-confirmed diagnosis of locally-advanced or metastatic adenocarcinoma of the pancreas
- Participants may be treatment naïve or have received prior therapy for the treatment of their PDAC. A minimum washout period of 14-days after...
You likely can't join if
- Concomitant use of other anti-cancer therapy otherwise not permitted in this protocol, including: chemotherapy, immunotherapy, hormonal therapy...
- Prior anti-cancer therapy within 2 weeks prior to study enrollment
- Prior treatment with a MYC inhibitor
- Known severe hypersensitivity to OMO-103 or to any excipient of these medicinal products, or history of allergic reactions attributed to compounds of...
- Major surgery within 6 weeks prior to enrollment
- Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and myocardial...
See the full eligibility criteria
- Must provide written informed consent before any study-specific procedures or interventions are performed
- Must be ≥ 18 years old at the time of informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Clinically-confirmed diagnosis of locally-advanced or metastatic adenocarcinoma of the pancreas
- Participants may be treatment naïve or have received prior therapy for the treatment of their PDAC. A minimum washout period of 14-days after completing the most recent line of therapy is required before a participant...
- Based on available imaging, participant must have at least one disease lesion that can be biopsied in accordance with institutional standards
- Patient agrees to undergo a minimum of 2 biopsies (pre- and post-treatment). Note: at principal investigator (PI) discretion, archival sample may be obtained in lieu of pre-treatment biopsy
- Hemoglobin ≥ 7.5 g/dL
- Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L (\> 1500 per mm\^3)
- Platelet count ≥ 75 x 10\^9/L (\> 100,000 per mm\^3)
- Calculated creatinine clearance \> 50 mL/min/1.73m\^2 (per Cockcroft-Gault equation)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT): ≤ 3 x upper limit of normal (ULN), or ≤ 5 x ULN in presence of liver metastases
- Participants of childbearing potential (POCBP) must agree to abstain from sexual intercourse or use effective methods of contraception starting with the first dose of study therapy through 6 months from the last dose of...
- POCBP may participate provided they have a negative serum pregnancy test at screening and a negative serum OR urine pregnancy test within 7 days of starting treatment
- Sperm-producing participants must agree to abstain from sexual intercourse or use effective contraception starting with the first dose through 6 months after last dose of study intervention
- Concomitant use of other anti-cancer therapy otherwise not permitted in this protocol, including: chemotherapy, immunotherapy, hormonal therapy (hormone replacement therapy is acceptable), radiotherapy (except for...
- Prior anti-cancer therapy within 2 weeks prior to study enrollment
- Prior treatment with a MYC inhibitor
- Known severe hypersensitivity to OMO-103 or to any excipient of these medicinal products, or history of allergic reactions attributed to compounds of similar chemical or biologic composition
- Major surgery within 6 weeks prior to enrollment
- Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and myocardial infarction within 3 months of initiating study intervention
- History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent
- Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.