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Pancreatic Ductal CarcinomaPhase 2NCT06813079

Using Tumor Models to Determine Treatments

A Phase 2 study testing Cobimetinib, Ponatinib and Brigatinib in people with Pancreatic Ductal Carcinoma and Advanced Cancer, run by University Health Network, Toronto at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to see if using Patient Derived Organoids (PDO) to choose a drug for the treatment of pancreatic cancer individually for each patient is useful. The study will look at the number of participants who have a response to their assigned drug. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cobimetinib, Ponatinib and Brigatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteCanada
Study dates
7 Apr 2025to 17 Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or over
  • Ability to understand and willing to sign a written informed consent form in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to screening to document their willingness to participate.
  • Advanced inoperable malignant epithelial pancreatic ductal carcinomas (i.e. primary diagnosis of ductal adenocarcinoma or acinar cell adenocarcinoma, inclusive of all subtypes)
  • Treatment history meeting one of either:
  • Stable disease or partial response to FOLFIRINOX (leucovorin calcium/folinic acid, fluorouracil, irinotecan hydrochloride, and oxaliplatin) after at least eight cycles of treatment (Cohort B)
  • Progression of disease after receiving standard of care chemotherapies (Cohort A).
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  • There is no maximum number of prior lines
  • Patients with recurrence within six months of adjuvant-intent chemotherapy will be eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Life Expectancy of greater than 12 weeks
  • Patients must have acceptable organ function
  • Patients must have baseline hepatitis B screening. If they have a positive surface antigen the case will discussed with the hepatologist to determine if therapy is indicated. This does not exclude them from study.
  • Patients must agree to use effective contraceptive methods for the period required by the study.
  • Patients must have measurable disease
  • Patient-derived organoid is sensitive to a drug listed for this study, defined by
  • Consensus agreement in molecular tumor boards, considering the totality of the genomic and organoid data, and the safety profile of the drug, and the clinical situation
  • Sensitivity to a drug chosen for the study, based on
  • IC50 < Cmax (maximum plasma concentration) ii. Area under the curve (AUC) < 30th percentile of cohort iii. Individual assay fulfills quality control metrics c. Matched clinical scenario (maintenance versus treatment) as outlined in this protocol.
  • Able to swallow and tolerate oral medication (as applicable)

Who cannot join

  • Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
  • Patient received last dose of chemotherapy within 21 days prior to Cycle 1 Day 1.
  • Patients with ongoing toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2, other than peripheral neuropathy, related to prior anti-tumour treatment.
  • Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.
  • Patients concurrently receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g. megestrol acetate, bisphosphonates). These medications must have been started ≥ one month prior to enrolment in this study.
  • Patients with a history of a severe allergic reaction attributed to compounds of similar or biologic composition to the PDO matched drug may be excluded if assessed by the investigator and determined to be unsafe to proceed.
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  • Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific ineligibility criteria.
  • Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within one month prior to screening. All patients with previously treated brain metastases must be stable (clinically and radiologically) for at least one month after completion of treatment and either off steroid treatment or only taking physiological doses of steroids prior to the screening step.
  • Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure.
  • Patients with known left ventricular ejection fraction (LVEF) < 40 % as determined by a multigated acquisition (MUGA) scan or echocardiogram.
  • Patients with stroke (including TIA) or acute myocardial infarction within three months prior to the screening step.
  • Patients with acute gastrointestinal bleeding within one month prior to the screening step.
  • Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations.
  • Lactating and nursing women.
  • Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1M9

    Robert C. Grant, MD, 416-946-4501 ext. 3308, robert.grant@uhn.ca

    Robert C. Grant, MD

    Recruiting

Other trials in Canada

About this study

Official title: ADOPT: Adaptive Organoid-Based Precision Therapy Study in Pancreatic Cancer - A Prospective Single-Arm Phase II Trial

The purpose of this study is to see if using Patient Derived Organoids (PDO) to choose a drug for the treatment of pancreatic cancer individually for each patient is useful. The study will look at the number of participants who have a response to their assigned drug.

Read the detailed description

PDO is a three-dimensional experimental model grown in a laboratory from patient's tumour tissues. PDO is used to test different drugs and select the drugs that may work for treating the patient's cancer. Researchers will review participants' PDO drug results from other studies from which they participated in and will identify the drug that seem to have the best effect on the PDO model. Participants will be offered to receive that drug during the study.

Being tested
Cobimetinib, Ponatinib, Brigatinib, Colchicine, Selinexor
Medical subject headings
Carcinoma, Pancreatic Ductal, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CobimetinibDrug

    Cobimetinib is an antineoplastic agent and selective inhibitor of the mitogen-activated extracellular kinase (MEK) pathway.

    Participants will take cobimetinib by mouth (orally), once a day on days 1 to 21 followed by a 7-day break of each cycle. A cycle will be 28 days in length.

  • PonatinibDrug

    Ponatinib is a type of drug called a protein tyrosine kinase inhibitor (TKI). Tyrosine kinases are proteins that act as chemical messengers to stimulate cancer cells to grow. Ponatinib blocks and interferes with a number of protein kinases. It is called a multi kinase inhibitor.

    Participants will take ponatinib by mouth (orally), once a day, every day of each cycle. A cycle will be 28 days.

  • BrigatinibDrug

    Brigatinib is a type of cancer growth blockers called a tyrosine kinase inhibitor (TKI). It blocks chemical signals (enzymes) from tyrosine kinase proteins. Tyrosine kinases help to send growth signals in cells, so blocking them stops the cell growing and dividing.

    Participants will take brigatinib by mouth (orally), once a day for the first 7 days. If participants are able to tolerate the dose during the first 7 days, they will take the doubled dose orally, once a day until end of the cycle (day 8 to day 28). Each cycle will be 28 days in length.

  • ColchicineDrug

    Colchicine is an alkaloid that affects the way the body responds to uric acid crystals, and reduces swelling and pain.

    On the first day, participants will take two tablets of colchicine by mouth (orally), then one tablet orally one hour later. Starting the second day, participants will take one tablet of colchicine once or twice a day, every day of each cycle. A cycle will be 28 days in length. The study doctor will decide whether participants will take colchicine once or twice a day.

  • SelinexorDrug

    Selinexor blocks a protein called CRM1, a protein within the cell, and may help keep cancer cells from growing and may kill them. It is a type of small molecule inhibitor.

    Participants will take selinexor by mouth (orally), once a week on days 1, 8, 15, and 22 of each cycle. A cycle will be 28 days in length.

  • AbemaciclibDrug

    Abemaciclib belongs to a class of medications called kinase inhibitors. Abemaciclib works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

    Participants will take abemaciclib by mouth (orally), twice a day, every day of each cycle. A cycle will be 28 days in length.

  • NeratinibDrug

    Neratinib is a targeted cancer drug that works on a protein called human epidermal growth factor receptor 2 (HER2). HER2 proteins make cells divide and grow. Some cancers have large amounts of HER2 proteins which can cause cancer cells to divide and grow faster. Neratinib works by locking onto the HER2 on the cancer cells. So it stops the cells from growing.

    Participants will take neratinib by mouth (orally), once a day, every day of each cycle. Dose will increase weekly, until week 3. On week 3 and onward, participants will take the same dose. A cycle will be 28 days in length.

  • DoxorubicinDrug

    Doxorubicin is a type of chemotherapy drug called an anthracycline. It slows or stops the growth of cancer cells by blocking an enzyme called topo isomerase 2. Cancer cells need this enzyme to divide and grow.

    Participants will receive doxorubicin by vein (intravenous infusion or IV) in clinic, over 60-90 minutes, once every cycle. A cycle will be 21 days in length. Participants may receive 6-8 cycles of study drug.

  • EtoposideDrug

    Etoposide is a chemotherapy drug that destroys quickly dividing cells, such as cancer cells.

    Participants will receive etoposide by mouth (orally), twice a day, on days 1 to 7 of every cycle. On days 8 to 21, there will be no dosing. A cycle will be 21 days in length.

  • CeritinibDrug

    Ceritinib is a tyrosine kinase inhibitor. It works by blocking an enzyme called anaplastic lymphoma kinase (ALK). Ceritinib only works in cancer cells that have an overactive version of ALK.

    Participants will take ceritinib by mouth (orally), once a day, every day of each cycle. A cycle will be 28 days in length.

Study groups in NCT06813079
Study groupRoleWhat they receive
Cohort AExperimentalPatients in this cohort will be entering the study for treatment for progressive disease.
Receives: Drug: Cobimetinib; Drug: Ponatinib; Drug: Brigatinib; Drug: Colchicine; Drug: Selinexor; Drug: Abemaciclib; Drug: Neratinib; Drug: Doxorubicin; Drug: Etoposide; Drug: Ceritinib
Cohort BExperimentalPatients in this cohort will be entering the study for maintenance therapy with stable disease.
Receives: Drug: Cobimetinib; Drug: Ponatinib; Drug: Brigatinib; Drug: Colchicine; Drug: Selinexor; Drug: Abemaciclib; Drug: Neratinib; Drug: Doxorubicin; Drug: Etoposide; Drug: Ceritinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    Measured: 3 years

Secondary outcomes (24)
  1. Disease control rate (DCR)

    Measured: 3 years

  2. Duration of response (DOR)

    Measured: 3 years

  3. Progression free survival (PFS)

    Measured: 3 years

  4. Overall survival (OS)

    Measured: 3 years

  5. Number of side effects experienced with participants in Cohort A assigned to cobimetinib

    Measured: 3 years

  6. Number of side effects experienced with participants in Cohort B assigned to cobimetinib

    Measured: 3 years

  7. Number of side effects experienced with participants in Cohort A assigned to ponatinib

    Measured: 3 years

  8. Number of side effects experienced with participants in Cohort B assigned to ponatinib

    Measured: 3 years

  9. Number of side effects experienced with participants in Cohort A assigned to brigatinib

    Measured: 3 years

  10. Number of side effects experienced with participants in Cohort B assigned to brigatinib

    Measured: 3 years

  11. Number of side effects experienced with participants in Cohort A assigned to colchicine

    Measured: 3 years

  12. Number of side effects experienced with participants in Cohort B assigned to colchicine

    Measured: 3 years

  13. Number of side effects experienced with participants in Cohort A assigned to selinexor

    Measured: 3 years

  14. Number of side effects experienced with participants in Cohort B assigned to selinexor

    Measured: 3 years

  15. Number of side effects experienced with participants in Cohort A assigned to ceritinib

    Measured: 3 years

  16. Number of side effects experienced with participants in Cohort B assigned to ceritinib

    Measured: 3 years

  17. Number of side effects experienced with participants in Cohort A assigned to abemaciclib

    Measured: 3 years

  18. Number of side effects experienced with participants in Cohort B assigned to abemaciclib

    Measured: 3 years

  19. Number of side effects experienced with participants in Cohort A assigned to neratinib

    Measured: 3 years

  20. Number of side effects experienced with participants in Cohort B assigned to neratinib

    Measured: 3 years

  21. Number of side effects experienced with participants in Cohort A assigned to doxorubicin

    Measured: 3 years

  22. Number of side effects experienced with participants in Cohort B assigned to doxorubicin

    Measured: 3 years

  23. Number of side effects experienced with participants in Cohort A assigned to etoposide

    Measured: 3 years

  24. Number of side effects experienced with participants in Cohort B assigned to etoposide

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2025
  2. Study start7 Apr 2025
  3. Primary completion17 Feb 2028 (estimated)
  4. Study completion17 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06813079
Sponsor's protocol ID
ADOPT
Other IDs
24-5059
Status last verified
Jun 2026
First submitted
3 Feb 2025
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cobimetinib, Ponatinib and Brigatinib in people with Pancreatic Ductal Carcinoma and Advanced Cancer, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Robert C. Grant, MD (416-946-4501 ext. 3308, robert.grant@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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