Study of bemarituzumab treatment for patients with solid tumors that have high levels of FGFR2b protein

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What is this study about?

This study focuses on various types of solid tumors that have a specific characteristic called FGFR2b overexpression. The types of cancer being studied include head and neck squamous cell carcinoma, triple-negative breast cancer, intrahepatic cholangiocarcinoma, lung adenocarcinoma, ovarian epithelial carcinoma, endometrial adenocarcinoma, and cervical carcinoma. The treatment being tested is a medicine called bemarituzumab (also known as AMG 552), which is given through an intravenous infusion directly into the bloodstream.

The purpose of this research is to test how safe bemarituzumab is and how well it works in treating different types of solid tumors. The study is divided into two parts. In the first part, doctors will closely monitor how patients respond to the medication and any side effects that may occur. In the second part, they will evaluate how effective the medication is at fighting the cancer.

During the study, patients will receive bemarituzumab through regular infusions. The doctors will track the progress of the treatment using different medical tests and imaging scans such as computed tomography (CT) or magnetic resonance imaging (MRI). They will monitor how the tumors respond to the treatment and keep track of any changes in the patient’s health throughout the study period.

1 Initial eligibility verification

Your cancer type must be confirmed through tissue examination and meet specific requirements for prior treatments

Your tumor must show high levels of FGFR2b protein through a special laboratory test

Your cancer must be measurable using standard imaging techniques

Blood tests will be performed to verify adequate organ function

2 Treatment phase initiation

Bemarituzumab will be administered through an intravenous infusion

Regular monitoring of vital signs during and after infusion

Vision tests will be conducted to monitor eye health

Blood samples will be collected to measure drug levels in your body

3 Ongoing monitoring

Regular imaging scans (CT or MRI) to measure tumor response

Blood tests to monitor organ function

Assessment of any side effects or changes in health status

Vision checks will continue throughout treatment

4 Response evaluation

Your response to treatment will be assessed through regular imaging scans

The medical team will evaluate if the tumor has shrunk (partial response) or disappeared (complete response)

The duration of any positive response will be tracked

Your overall health status will be monitored throughout the study period

5 Long-term follow-up

Continued monitoring of your health status

Regular assessment of cancer progression

Documentation of long-term treatment outcomes

The study is expected to continue until September 2026

Who Can Join the Study?

  • Must be an adult (18 years or older)
  • Must have a confirmed diagnosis of one of these cancers that has returned or not responded to previous treatment:
    • Head and neck cancer (after at least 1 previous treatment)
    • Triple-negative breast cancer (after at least 2 previous treatments)
    • Bile duct cancer (after at least 1 previous treatment)
    • Lung cancer (after chemotherapy, immunotherapy, and targeted therapy if applicable)
    • Ovarian, fallopian tube, or peritoneal cancer that has progressed within 6 months of platinum treatment
    • Endometrial cancer (after at least 1 previous treatment)
    • Cervical cancer (after at least 1 previous treatment)
    • Other solid tumors (after at least 1 previous treatment)
  • Must have tumors that show high levels of a protein called FGFR2b through special testing
  • Must have tumors that can be measured using specific criteria (RECIST)
  • Must have adequate blood cell counts:
    • White blood cells (neutrophils) at least 1.5 x 10^9/L
    • Platelets at least 100 x 10^9/L
    • Hemoglobin at least 9 g/dL
  • Must have adequate liver function
  • Must have adequate kidney function
  • Must have normal blood clotting function (unless on blood thinners with stable dosing for at least 6 weeks)

Who Cannot Join the Study?

  • History of severe allergic reactions or anaphylaxis (serious, life-threatening allergic reactions)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Significant heart problems including:
    • Unstable heart disease
    • Heart attack within last 6 months
    • Uncontrolled high blood pressure
  • Active, uncontrolled infections
  • Other cancer diagnosis within the past 3 years (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
  • Pregnant or breastfeeding women
  • Major surgery within 4 weeks before starting the study treatment
  • Participation in another clinical trial within 4 weeks before starting this study
  • Serious medical conditions that could interfere with study participation
  • Known positive test for HIV, active hepatitis B, or active hepatitis C
  • History of organ transplantation
  • Current use of medications that could interact with the study drug

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Medical University Of Graz Graz Austria
Katholieke Universiteit te Leuven Leuven Belgium
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Orszagos Onkologiai Intezet Budapest Hungary
Hospital General Universitario Gregorio Maranon Madrid Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Grand Hopital De Charleroi Charleroi Belgium
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet Szolnok Hungary
University General Hospital Of Heraklion Heraklion Greece
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Azienda Ulss 3 Serenissima Venice Italy
Pratia S.A. Skorzewo Poland
Azienda Sanitaria Locale Napoli 1 Centro Naples Italy
Hospital Quironsalud Barcelona Barcelona Spain
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Institutul Regional De Oncologie Iasi Iasi Romania
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
Alexandra Hospital Athens Greece
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Da Luz S.A. Lisbon Portugal
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Universidade De Santiago De Compostela Santiago De Compostela Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Oncomed S.R.L. Timisoara Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
University Hospital Olomouc Olomouc Czechia
Rigshospitalet Copenhagen Denmark
Pirkanmaan hyvinvointialue Tampere Finland
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Ars Medical Sp. z o.o. Pila Poland
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Institut de Cancérologie de l’Ouest Saint-Herblain France
Hospital Universitario Virgen De La Victoria Malaga Spain
Ivenxxan Ragnmiiv Df Chdbxg De Mvifiicnkgk Montpellier France
Sgrrmootvn Eokuapv Budapest Hungary
Sojdfojhg Rmelcwk Uzmtoqaxut Msmpxqj Chxhmq Nijmegen The Netherlands
Dynbanwp Ot Helsinki Finland
Cnutuxpww Uqylcxaerphlyd Sfrhxaibs Woluwe-Saint-Lambert Belgium
Lrtno Gclefwk Hjdixcqv Ok Axyolt Athens Greece
Bzfcmxqq Ukbzupqtdr Htlwbmgl Cjvpnn Besançon France
Anqyihy Oxzhxnfudtq Ucpruwhykvpfv Oeikawvb Rpfhybe Foggia Italy
Alioiu Mxfamcz Cbbasm Stvh Thessaloniki Greece
Mwxevmhk Mbdqdhf Axttyar Pleven Bulgaria
Uclglzlrju Oz Arhzzsk Edegem Belgium
Ufmtaflwjs Djzae Smoeu Dx Rwzc Le Szrxhebn Rome Italy
Utqveagcyqek Mnvywba Cypwjiz Gzsiizsbk Groningen The Netherlands
Hwrwxuzl Vjla dsaiunoq Barcelona Spain
Irmngrbn Pyccptrnkpdbhzr Cdfttm Cfktkz Marseille France
Cxpjjf Okymh Lhciaht Lille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
28.03.2022
Belgium Belgium
Not recruiting
28.03.2022
Bulgaria Bulgaria
Not recruiting
28.03.2022
Czechia Czechia
Not recruiting
28.03.2022
Denmark Denmark
Not recruiting
28.03.2022
Finland Finland
Not recruiting
28.03.2022
France France
Not recruiting
28.03.2022
Greece Greece
Not recruiting
28.03.2022
Hungary Hungary
Not recruiting
28.03.2022
Italy Italy
Not recruiting
28.03.2022
Poland Poland
Not recruiting
28.03.2022
Portugal Portugal
Not recruiting
28.03.2022
Romania Romania
Not recruiting
28.03.2022
Spain Spain
Not recruiting
28.03.2022
The Netherlands The Netherlands
Not recruiting
28.03.2022

Trial locations

Investigated drugs:

Bemarituzumab is a targeted therapy medication that works by binding to a specific protein called FGFR2b found on the surface of certain cancer cells. This medication is being studied as a standalone treatment for patients who have solid tumors that produce too much FGFR2b protein. It is designed to help fight cancer by targeting and blocking the activity of this protein, which may help stop cancer cells from growing and spreading.

Solid tumors – A type of cancer that develops as a solid mass of abnormal cells in various organs or tissues of the body. These growths form when cells multiply uncontrollably and cluster together, creating lumps or masses that can occur in many different parts of the body such as the breast, lung, colon, or other organs. Solid tumors can be either benign (non-cancerous) or malignant (cancerous), with malignant tumors having the ability to invade nearby tissues. The growth of solid tumors typically progresses gradually as cells continue to multiply and the mass increases in size. These tumors can often be detected through physical examination or imaging when they reach a certain size.

Trial ID:
2023-505455-44-00
Protocol code:
20210104
NCT ID:
NCT05325866
Trial Phase:
Human Pharmacology (Phase I) – Other

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