Actively Recruiting
Targeted Pathway Inhibition in Patients With Pancreatic Cancer
Led by OHSU Knight Cancer Institute · Updated on 2026-02-27
90
Participants Needed
1
Research Sites
443 weeks
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
A
American Association for Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
This early phase I trial aims to determine how cobimetinib, olaparib, onvansertib, azenosertib, AZD5305 or tremelimumab works in patients with pancreatic cancer. Validation of cobimetinib, olaparib, onvansertib azenosertib, AZD5305 and tremelimumab molecular targets will be explored by comparing pre-treatment biopsies with post-treatment specimens. This knowledge will help design future biomarker driven trials to determine whether giving cobimetinib, or olaparib, or onvansertib or azenosertib, or AZD5305, or tremelimumab will work better than standard treatments in patients with pancreatic cancer.
CONDITIONS
Official Title
Targeted Pathway Inhibition in Patients With Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent
- Age 18 years or older
- ECOG performance status of 0 to 2
- Clinically confirmed diagnosis of resectable, borderline resectable, locally advanced, or metastatic pancreatic adenocarcinoma
- At least one lesion suitable for biopsy based on imaging
- Hemoglobin 9.0 g/dL or higher without recent blood transfusion
- White blood cell count greater than 3 x 10^9/L
- Absolute neutrophil count 1.5 x 10^9/L or higher (may be waived in some cases)
- Platelet count 100 x 10^9/L or higher
- Creatinine within 1.5 times upper limit of normal or creatinine clearance 60 mL/min/1.73m^2 or higher
- Serum bilirubin 1.5 times upper limit of normal or less
- AST and ALT 2.5 times upper limit of normal or less
- Willingness to undergo mandatory tumor biopsies during the study
- Ability to comply with study protocol including treatment and visits
- Ability to swallow tablets or capsules without gastrointestinal impairment
- Negative pregnancy test if of childbearing potential
- Agreement to use contraception during and after study treatment
- No invasive malignancy recently except certain treated skin or in situ cancers
- No active hepatitis B; controlled hepatitis C allowed
- HIV infection allowed if stable with criteria met
- For azenosertib arm: no prior WEE1 inhibitor treatment
- For azenosertib arm: no recent major surgery, recent radiation, stem cell transplant, investigational agents with prolonged effects, or CYP3A inducers
- For azenosertib arm: no symptomatic brain metastases or leptomeningeal disease requiring immediate treatment
- For azenosertib arm: no severe gastrointestinal abnormalities
- For azenosertib arm: no active uncontrolled infection
- For azenosertib arm: QTcF less than or equal to 480 ms except specific conditions
- For azenosertib arm: no history of long QT syndrome or Torsade de Pointes
- For azenosertib arm: no unresolved toxicity greater than grade 1 from prior therapies
- For azenosertib arm: no hypersensitivity to similar drugs
- For azenosertib arm: not pregnant or breastfeeding
- For azenosertib arm: contraception agreement and sperm donation restrictions
- For azenosertib arm: no medications causing significant QT prolongation
- For azenosertib arm: no strong/moderate CYP3A4 or P-gp inhibitors or inducers
- For azenosertib arm: avoid certain citrus fruits and juices during study
- For AZD5305 arm: contraception agreement including use after treatment
- For tremelimumab arm: contraception agreement including use after treatment
You will not qualify if you...
- Tumor not accessible for core biopsy
- Medical conditions making surgery too risky as per institutional standards
- Major surgery within 4 weeks or minor surgery within 2 weeks before study treatment
- Use of strong or moderate CYP3A inducers or inhibitors
- Use of other anti-cancer therapies or live vaccines during study medication
- Known severe hypersensitivity to study agents or their excipients
- Clinically significant uncontrolled heart disease or arrhythmia
- QTcF greater than 470 ms (females) or 450 ms (males) or congenital long QT syndrome
- Heart attack or unstable angina within 6 months before screening
- Pregnant or lactating female participants
- Conditions impairing swallowing or gastrointestinal absorption
- Active uncontrolled infections
- Psychiatric or social issues limiting study compliance
- History of hypersensitivity to study agents
- Pregnancy, breastfeeding, or planning pregnancy during study and 120 days after
- AZD5305 arm: allergy to AZD5305 or excipients
- AZD5305 arm: myelodysplastic syndrome or acute myeloid leukemia
- AZD5305 arm: cardiovascular disease or QTc over 450 ms
- AZD5305 arm: history of severe pancytopenia
- Tremelimumab arm: medical risks making surgery too risky
- Tremelimumab arm: prior immunotherapy for pancreatic cancer
- Tremelimumab arm: unresolved toxicity greater than grade 2 from prior therapy
- Tremelimumab arm: history or evidence of severe lung or autoimmune conditions
- Tremelimumab arm: active or prior autoimmune or inflammatory disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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