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Lab-Grown mini tumors could guide pancreatic cancer treatment
NCT ID NCT06813079
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study explores whether growing miniature versions of a patient's own pancreatic tumor in the lab (called organoids) can help doctors choose the most effective drug for that individual. About 25 adults with advanced, inoperable pancreatic cancer will have their tumor organoids tested against two drugs, cobimetinib and ponatinib. The goal is to see if this personalized approach leads to tumor shrinkage or better disease control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cobimetinib and Ponatinib
- What this could lead to
- If successful, this approach could make treatment for advanced pancreatic cancer more personalized and effective, potentially improving survival and quality of life.
- What could go wrong
- This is a small, early-phase trial (25 participants) testing a new method. The drugs may not work for everyone, and side effects could be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 years or over 2. 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. 3. Advanced inoperable malignant epithelial pancreatic ductal carcinomas (i.e. primary diagnosis of ductal adenocarcinoma or acinar cell adenocarcinoma, inclusive of all subtypes) 4. Treatment history meeting one of either: 1. 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) 2. Progression of disease after receiving standard of care chemotherapies (Cohort A). i. There is no maximum number of prior lines ii. Patients with recurrence within six months of adjuvant-intent chemotherapy will be eligible 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 6. Life Expectancy of greater than 12 weeks 7. Patients must have acceptable organ function 8. 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. 9. Patients must agree to use effective contraceptive methods for the period required by the study. 10. Patients must have measurable disease 11. Patient-derived organoid is sensitive to a drug listed for this study, defined by 1. 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 2. Sensitivity to a drug chosen for the study, based on i. 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. 12. Able to swallow and tolerate oral medication (as applicable) Exclusion Criteria: 1. 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. 2. Patient received last dose of chemotherapy within 21 days prior to Cycle 1 Day 1. 3. Patients with ongoing toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2, other than peripheral neuropathy, related to prior anti-tumour treatment. 4. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded. 5. 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. 6. 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. 7. Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific ineligibility criteria. 8. 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. 9. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure. 10. Patients with known left ventricular ejection fraction (LVEF) \< 40 % as determined by a multigated acquisition (MUGA) scan or echocardiogram. 11. Patients with stroke (including TIA) or acute myocardial infarction within three months prior to the screening step. 12. Patients with acute gastrointestinal bleeding within one month prior to the screening step. 13. 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. 14. Lactating and nursing women. 15. Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Princess Margaret Cancer Centre
RECRUITINGToronto, Ontario, M5G 1M9, Canada
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