Phase 2/3 study of telisotuzumab adizutecan with drug combination versus standard care in adults with first‑line metastatic pancreatic ductal adenocarcinoma

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What is this study about?

The condition being studied is metastatic pancreatic ductal adenocarcinoma, an advanced form of pancreatic cancer that has spread to other parts of the body. The experimental treatment combines an intravenous antibody called Telisotuzumab adizutecan with a chemotherapy regimen known as FOLFOX, which contains fluorouracil, calcium folinate, and oxaliplatin. For comparison, participants may receive the usual standard of care that can include irinotecan together with the same chemotherapy drugs.

The main goal of the trial is to determine whether the new combination is safe and works better than current therapies. Participants will receive the assigned medicines by IV infusion in repeated cycles, with regular hospital visits for the infusions and for medical checks. Throughout the study, doctors will look for signs that tumors shrink, known as objective response, and will track how long patients live, referred to as overall survival.

After random assignment to either the experimental group or the standard‑care group, treatment continues for several weeks while imaging scans, blood tests, and questionnaires are used to assess tumor size, side effects, and quality of life. The study also measures how long the disease stays under control without getting worse, called progression‑free survival, before participants are followed for long‑term survival outcomes.

1 baseline evaluation

after enrollment, a complete medical history, physical examination, laboratory tests and imaging studies are performed to document the current condition.

the purpose is to create a reference point for later comparison with future assessments.

2 first treatment administration

on the first scheduled day, the patient receives four intravenous (iv) infusions:

telisotuzumab adizutecan (dose 00 mg as defined in the protocol),

fluorouracil (dose 00 mg iv),

calcium folinate (dose 00 mg iv), and

oxaliplatin (dose 00 mg iv).

each medicine is given through a vein using a drip pump, following the timing and order specified in the study protocol.

3 repeated treatment cycles

subsequent cycles of the same four iv infusions are given according to the schedule defined in the protocol.

the patient returns to the clinic for each cycle, receives the medicines, and is monitored throughout the infusion.

treatment continues until the protocol‑specified end point, disease progression, or unacceptable side effects.

4 regular monitoring visits

before each infusion, blood tests are drawn to check organ function and blood counts.

a brief physical examination is performed to assess any new symptoms.

the clinical staff records any side effects and adjusts care as needed.

5 imaging assessments

at intervals defined by the protocol, imaging studies such as CT scans are performed to evaluate tumor response.

the results are compared with the baseline evaluation to determine whether the cancer is shrinking, stable, or growing.

6 end of treatment evaluation

after the final scheduled infusion, a comprehensive assessment is carried out.

this includes a physical exam, laboratory tests, and imaging to document the disease status at the end of therapy.

7 post‑treatment follow‑up

the patient continues to be seen at scheduled visits after treatment has stopped.

follow‑up visits include blood tests, physical examinations and imaging as required by the protocol to monitor overall survival and long‑term safety.

Who Can Join the Study?

Have a type of pancreatic cancer called adenocarcinoma that cannot be removed by surgery (unresectable) and has spread to other parts of the body (metastatic), and this diagnosis must be confirmed by looking at the cancer cells under a microscope (histologically‑ or cytologically‑confirmed).
Be able to perform daily activities with a score of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance status scale, where 0 means fully active and 1 means able to do light work but not fully active.
Agree to let the study team use a stored or recently taken sample of your tumor tissue (tumor tissue) for testing during the screening process.
Have tumors that can be measured on scans, using the rules called Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, which help doctors track how the cancer changes over time.

Who Cannot Join the Study?

Having any previous chemotherapy, hormone therapy, targeted drug treatment, major surgery, or radiation (except low‑dose comfort‑care radiation) for cancer that could not be removed or had spread to other parts of the body.
Having taken medicines that specifically block the c-MET protein, which is a type of targeted cancer therapy.
Having a past or current lung problem called interstitial lung disease (ILD) or pneumonitis that needed treatment with strong anti‑inflammatory drugs (systemic steroids), or any sign of an active lung problem on a screening chest scan (CT). This includes conditions such as:
- idiopathic pulmonary fibrosis – a scar‑forming lung disease with unknown cause,
- organizing pneumonia (for example, bronchiolitis obliterans) – a type of lung inflammation that can block small airways,
- drug‑induced pneumonitis – lung inflammation caused by medicines,
- idiopathic pneumonitis – lung inflammation with no known cause.
Having had a bone‑marrow transplant, a solid‑organ transplant (such as kidney, liver, or heart), or a previous medical diagnosis of tuberculosis (a bacterial infection that mainly affects the lungs).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal
Centre Hospitalier Universitaire De Lille	Lille	France
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
IRCCS Humanitas Research Hospital	Rozzano	Italy
Medical University Of Vienna	Vienna	Austria
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Hospital Paul Brousse	Villejuif	France
Champalimaud Clinical Centre	Lisbon	Portugal
Centre Hospitalier Universitaire De Nantes	Nantes	France
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Uniklinikum Salzburg	Salzburg	Austria
Caampq Hqcjqmitpni Uzdldqgslukfo Dn Dmdqr	Dijon	France
Hiyssmmy Vhvo drvnkppg	Barcelona	Spain
Usceylvixc Mdjrruj Cnfpim Huhesqnivsolfbhtx	Hamburg	Germany
Ufexqytyzsuhwaledomhx Ercvq Ace	Essen	Germany
Opkjjpyzsrahma Lkkc Gmmw	Linz	Austria

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	04.01.2027
France	Not yet recruiting	04.01.2027
Germany	Not yet recruiting	04.01.2027
Italy	Not yet recruiting	04.01.2027
Portugal	Not yet recruiting	04.01.2027
Spain	Not yet recruiting	04.01.2027

Trial locations

Investigated Drugs:

Telisotuzumab adizutecan is an experimental antibody given by IV infusion. It is designed to attach to certain proteins on cancer cells and help the immune system recognize and attack those cells. In this study it is tested together with other chemotherapy drugs to see if it improves safety and how well it works against pancreatic cancer.

Fluorouracil is a chemotherapy medicine that is given through an IV. It works by stopping cancer cells from making DNA, which prevents them from growing and dividing. In the trial it is part of the standard chemotherapy combination used for treating pancreatic cancer.

Oxaliplatin is a chemotherapy drug given by IV infusion. It contains platinum, which damages the DNA inside cancer cells and leads to cell death. It is used together with other drugs in the standard treatment regimen for pancreatic cancer.

Calcium folinate (also known as leucovorin) is a vitamin‑like substance given intravenously. It does not kill cancer cells by itself, but it makes fluorouracil work better by helping it stay inside cancer cells longer. It is included in the standard chemotherapy mix for pancreatic cancer.

Irinotecan is a chemotherapy agent administered by IV. It interferes with an enzyme that cancer cells need to copy their DNA, which stops the cells from growing. In this study it is listed as a comparator treatment that may be used as part of the standard care options.

Metastatic pancreatic ductal adenocarcinoma – Metastatic pancreatic ductal adenocarcinoma is a cancer that begins in the cells lining the main ducts of the pancreas and has spread to other parts of the body. The disease often starts without clear symptoms, and as it grows it can cause abdominal pain, weight loss, and digestive problems. Cancer cells travel through the bloodstream or lymph system, forming new tumors in organs such as the liver, lungs, or peritoneum. As more sites become involved, the overall burden of disease increases, leading to further decline in organ function.

Trial ID:

2025-522563-15-00

Protocol code:

M25-288

Trial Phase:

Therapeutic use (Phase IV)

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Phase 2/3 study of telisotuzumab adizutecan with drug combination versus standard care in adults with first‑line metastatic pancreatic ductal adenocarcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?