Actively Recruiting
A Window of Opportunity Strategy for Targeted Pathway Inhibition in Patients With Pancreatic Ductal Adenocarcinoma
Led by OHSU Knight Cancer Institute · Updated on 2026-02-27
90
Participants Needed
1
Research Sites
87 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
Researchers are evaluating how several drugs—cobimetinib, olaparib, onvansertib, azenosertib, AZD5305 (saruparib), and tremelimumab—affect patients with pancreatic cancer. This early phase I trial aims to understand changes in tumor biology after treatment and identify biomarkers that predict sensitivity or resistance to these agents. The results will support designing future studies to compare these targeted treatments against standard therapies for pancreatic cancer. Participants are assigned to one of six groups. Most receive an oral drug daily for 10 days, including azenosertib, AZD5305, cobimetinib, olaparib, or onvansertib, although the arms for olaparib, cobimetinib, and onvansertib are now closed. The tremelimumab group receives a single intravenous infusion. Within 12 to 24 hours after treatment, patients undergo a biopsy or surgery as appropriate. After treatment, patients are followed for 12 months to monitor outcomes. During the study, participants have biopsies before and after treatment to detect changes in tumor biology. Researchers assess safety, tolerability, and molecular changes in tumor cells. Blood tests and clinical evaluations are conducted to monitor health and side effects. The main goal is to measure tumor changes after treatment. Safety is monitored for up to 30 days, and patients are observed for one year following treatment completion.
CONDITIONS
Brief 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Confirmed diagnosis of resectable, borderline resectable, locally advanced, or metastatic pancreatic adenocarcinoma
- At least one disease lesion suitable for biopsy
- Hemoglobin ≥ 9.0 g/dL without blood transfusion within 28 days
- White blood cell count > 3 x 10^9/L
- Absolute neutrophil count ≥ 1.5 x 10^9/L (may be waived in some cases)
- Platelet count ≥ 100 x 10^9/L
- Creatinine ≤ 1.5 times upper limit of normal or creatinine clearance ≥ 60 mL/min/1.73m²
- Serum bilirubin ≤ 1.5 times upper limit of normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Willing to undergo mandatory tumor biopsies
- Able to comply with protocol including treatment and visits
- Able to swallow tablets or capsules
- Negative pregnancy test if of childbearing potential
- Agree to use adequate contraception during study and specified periods
- No other prior invasive malignancy except certain treated cancers
- No active hepatitis B; controlled hepatitis C allowed
- HIV positive patients allowed if stable with specific criteria
- For azenosertib arm, no prior WEE1 inhibitor treatment and other specific criteria
You will not qualify if you...
- Tumor not accessible for core biopsy
- Medical conditions making surgery too risky
- Recent major surgery within 4 weeks or minor surgery within 2 weeks before treatment
- Use of strong or moderate CYP3A inducers or inhibitors
- Use of other anti-cancer therapies or live vaccines during study
- Known severe allergy to study drugs or related compounds
- Significant uncontrolled heart disease or abnormal ECG
- Pregnant or lactating women
- Conditions affecting swallowing or absorption of oral drugs
- Active uncontrolled infections
- Psychiatric or social issues limiting study compliance
- History of hypersensitivity to study agents
- For AZD5305 arm, specific exclusions including allergy, blood disorders, and heart risks
- For tremelimumab arm, prior immunotherapy, unresolved toxicities, certain lung diseases, or autoimmune disorders
- Participants expected to conceive during study or shortly after
- Other specific medical or laboratory exclusions as per study arm requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 days
Participants receive assigned study drugs orally or one biological agent intravenously for up to 10 days depending on their assigned arm, in the absence of disease progression or unacceptable toxicity.
Daily dosing for up to 10 days
Duration - 1 to 2 days
Within 12 to 24 hours after treatment completion, participants undergo biopsy or surgery as clinically appropriate per institutional standards for management of their disease.
1 visit (in-person) within 1 day after treatment
Duration - 12 months
Participants are followed up for safety and disease status for up to 12 months after completion of study treatment.
Periodic visits for up to 12 months
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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