OMO-103 for the Treatment of Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
Recruiting
Early Phase 1Interventional Study
Locally Advanced Pancreatic Ductal AdenocarcinomaMetastatic Pancreatic Ductal AdenocarcinomaStage II Pancreatic Cancer AJCC v8Stage III Pancreatic Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
12 (estimated)
Sponsor
OHSU Knight Cancer Institute · Other
Who this trial is looking for
This trial is looking for adults with advanced pancreatic cancer that has spread to other areas. Participants will receive OMO-103 and undergo some tests, including biopsies, to see how the treatment affects their cancer.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have advanced pancreatic cancer that can be biopsied.
I can provide written consent to participate.
I have good overall health as measured by performance status.
I have enough blood counts and organ function.
I agree to have at least 2 biopsies during the trial.
If I am a woman able to become pregnant, I will use effective birth control.
If I am a man able to father children, I will use effective birth control.
You may not be able to join if
I have taken anti-cancer therapy in the last 2 weeks.
I have severe allergies to OMO-103 or similar drugs.
I have had major surgery in the last 6 weeks.
I have uncontrolled health issues like heart problems.
I have a history of psychiatric illness that affects my participation.
I am pregnant or breastfeeding.
I have previously taken a MYC inhibitor.
The doctor thinks I cannot follow the trial rules.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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. This trial m…
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. This trial may help researchers determine how exposure to OMO-103 changes pancreatic tumor cells.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion 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-…
Inclusion 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 can initiate treatment with study agent(s)
* 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 study intervention
* 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
Exclusion Criteria:
* 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 palliative), biological therapy, or other novel agent
* 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
Contacts
No contact information available.
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