Study of 177Lu-FAP-2286 alone and with drug combinations for patients with advanced solid tumors including non-small cell lung cancer, breast cancer, and pancreatic cancer

2 1 1 1

What is this study about?

This clinical trial is investigating treatments for patients with advanced solid tumors, specifically focusing on non-small cell lung cancer, breast cancer, and pancreatic ductal adenocarcinoma that has spread or cannot be removed by surgery. The study uses several medications including AAA614, paclitaxel, oxaliplatin, irinotecan, calcium folinate, and fluorouracil. Some of these drugs are combined into a treatment known as mFOLFIRINOX.

The study aims to test how well patients respond to these treatments and determine the safest and most effective doses. The main treatment being studied is a radioactive drug called [177Lu]Lu-FAP-2286, which will be given either alone or in combination with other cancer medications. This drug works by targeting specific proteins found in cancer cells.

During the study, patients will receive their assigned treatments through intravenous infusion, which means the medications are given directly into a vein. Doctors will monitor patients’ responses to treatment and track any side effects that may occur. The study includes different treatment groups depending on the type of cancer and previous treatments patients have received.

1 Initial medical assessment

Your eligibility will be confirmed through laboratory tests to check bone marrow function, liver function, and kidney function

A physical examination will be performed to assess your overall health status and confirm your ECOG performance status is 0 or 1 (ability to carry out daily activities)

Your tumor measurements will be taken using CT or MRI scans to confirm presence of measurable disease

2 Treatment administration – Imaging agent

You will receive an intravenous injection of [68Ga]Ga-FAP-2286, an imaging agent to assess your tumor

3 Treatment administration – Main therapy

Based on your cancer type, you will receive one of the following treatment combinations via intravenous infusion:

For pancreatic cancer: [177Lu]Lu-FAP-2286 combined with mFOLFIRINOX (combination of fluorouracil, calcium folinate, irinotecan, and oxaliplatin)

For lung cancer: [177Lu]Lu-FAP-2286 combined with paclitaxel

For breast cancer: [177Lu]Lu-FAP-2286 alone

4 Monitoring during treatment

Regular assessments will track your response to treatment using CT or MRI scans

Blood tests will be performed to monitor your organ function

Any side effects will be recorded and monitored

Treatment will continue until disease progression or other stopping criteria are met

5 End of treatment assessment

Final scans will be performed to assess your response to treatment

Final blood tests and physical examination will be conducted

Any ongoing side effects will be documented

Who Can Join the Study?

Must be at least 18 years old
Must sign an informed consent form before any study procedures
Must have one of these confirmed cancers:
- Recurring or spreading non-small cell lung cancer
- Breast cancer that has spread
- Pancreatic cancer that cannot be surgically removed or has spread
Must have adequate organ function, including:
- Good bone marrow function
- Proper liver function
- Good kidney function
Must have a good physical condition (ECOG score of 0 or 1, which means able to do light work)
Must have a life expectancy of at least 6 months
Must have measurable tumors that are at least:
- 10 millimeters for regular tumors
- 15 millimeters for affected lymph nodes
Must agree to provide tumor tissue samples if available
For breast cancer patients: Must have received previous treatments depending on cancer type
For pancreatic cancer patients: Must have had 1-2 previous chemotherapy treatments
For lung cancer patients: Must have had previous chemotherapy and immunotherapy treatments

Who Cannot Join the Study?

Prior history of allergic reactions to study medications or similar substances
Pregnant or breastfeeding women
Active brain metastases (cancer that has spread to the brain) that are untreated or unstable
Serious heart conditions including heart failure or uncontrolled high blood pressure
Major surgery within 4 weeks before starting the study
Current participation in other clinical trials
Severe kidney or liver problems
Active infections requiring treatment
History of other cancers within the past 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
Any condition that, in the opinion of the study doctor, would make participation unsafe
Unable to follow study procedures or attend scheduled visits
History of organ transplantation
Psychiatric illness or substance abuse that could interfere with the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Centre Jean Perrin	Clermont Ferrand	France
Hospital Clinico San Carlos	Madrid	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
IRCCS Ospedale Sacro Cuore Don Calabria	Negrar di Valpolicella	Italy
Iwnxqxqj Rqtldidr Dn Cmjhoo Dy Mmtbvjmkred	Montpellier	France
Iacsvwze Rlenbandq Pmt Ly Seopdc Drl Tgpdab Dvoy Axzruhu Ijep Swisww	Meldola	Italy
Arrymngtqd Ppzsxcqa Hjqcbvgd Ds Mkgdaqjpa	Marseille	France
Cnyg Dn Nxonk	Vandoeuvre Les Nancy	France
Afvgmdg Ufz Ihzgm Du Rdlhhu Eqhnjo	Reggio Emilia	Italy
Ufehvxccko Oa Aevqorp	Edegem	Belgium
Ihevdhej Crolqn Dxcwtmsnaibhkikzv	L'hospitalet De Llobregat	Spain
Hqrtggfn Uxicdpyhfcdiz db A Cwrcuc	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	31.07.2025
France	Recruiting	31.07.2025
Italy	Not yet recruiting	31.07.2025
Spain	Recruiting	31.07.2025

Trial locations

Investigated drugs:

Based on the provided trial information, here are the medications involved:

Lu FAP-2286 is a radioactive medication used to target and treat advanced solid tumors. It contains lutetium-177, which delivers targeted radiation therapy to cancer cells.

mFOLFIRINOX is a combination chemotherapy treatment that includes multiple cancer-fighting drugs used together to treat pancreatic cancer (PDAC).

Nab-paclitaxel is a chemotherapy medication that is bound to protein particles, used to treat non-small cell lung cancer (NSCLC). It works by stopping cancer cells from dividing and growing.

Investigated diseases:

Non-small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the cells of the lungs and can spread to other parts of the body. It develops when lung cells begin to grow abnormally and form tumors. NSCLC accounts for most lung cancer cases and typically grows and spreads more slowly than small cell lung cancer.

Breast Carcinoma (BC) – A cancer that forms in the cells of the breast tissue. It occurs when breast cells begin to grow uncontrollably, forming a tumor that can be felt as a lump or seen on imaging. The cancer can develop in different parts of the breast and may spread to surrounding tissues.

Pancreatic Ductal Adenocarcinoma (PDAC) – A cancer that develops in the ducts of the pancreas, which are tubes that carry digestive enzymes. It begins when cells in the pancreatic ducts start to grow uncontrollably. PDAC is the most common type of pancreatic cancer and affects the organ’s ability to produce digestive enzymes and hormones.

Trial ID:

2023-508995-12-01

Protocol code:

CAAA614A12101

NCT ID:

NCT04939610

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of 177Lu-FAP-2286 alone and with drug combinations for patients with advanced solid tumors including non-small cell lung cancer, breast cancer, and pancreatic cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?