A study of pumitamig and a drug combination versus bevacizumab and a drug combination for patients with untreated, unresectable, or metastatic colorectal cancer

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What is this study about?

This study is designed to compare the effectiveness of different treatment combinations for people with Colorectal Cancer that has not been treated before, cannot be removed by surgery, or has spread to other parts of the body. The research focuses on comparing a combination involving the drug pumitamig, also known as BNT327, with a standard treatment combination that includes bevacizumab.

The treatment groups will receive various medications. One group will receive a combination of pumitamig with several chemotherapy drugs, including oxaliplatin, calcium folinate, fluorouracil, irinotecan hydrochloride trihydrate, and capecitabine. These drugs are administered through different methods, such as an infusion, which is a liquid medicine delivered directly into a vein, or by oral use, which means taking the medicine by mouth. The other group will receive a combination of bevacizumab along with a set of chemotherapy drugs.

The study is divided into two stages. The first stage aims to see how many people experience a reduction in tumor size after receiving the treatment. The second stage focuses on observing how long the treatment keeps the cancer from growing or spreading further. Throughout the process, information is gathered to understand how well the medicines work and how they are tolerated by the body.

Who Can Join the Study?

  • You must be at least 18 years old.
  • You must have colorectal cancer (cancer in the large intestine or rectum) that has returned, spread to other parts of the body, or cannot be removed through surgery (an operation to cut out the tumor).
  • You must not have received any previous cancer treatments.
  • You must not have a specific type of colorectal cancer known as dMMR/MSI-H, which refers to certain genetic changes in how cells repair their DNA.
  • You must not have a BRAF V600E gene mutation, which is a specific change or error in the DNA that can cause cancer cells to grow.
  • Your cancer must be large enough or in a location that can be seen and measured using a scan (an imaging test like a CT or MRI).

Who Cannot Join the Study?

  • You cannot participate if your cancer has spread to the brain, spinal cord, or nearby areas and has not been treated (received medical care to stop or manage the disease).
  • You cannot participate if you have had another type of active cancer (cancer that is currently growing or spreading) within the last 2 years, unless it was a low-risk case that was cured locally (successfully treated in one specific area).
  • You cannot participate if you have serious heart problems, such as a recent heart attack (when blood flow to the heart is blocked), a stroke (when blood flow to the brain is blocked), blocked arteries (narrowing of the tubes that carry blood), uncontrolled high blood pressure, or certain genetic heart rhythm issues (irregular heartbeats caused by your DNA).
  • You cannot participate if you have already taken checkpoint inhibitors (medicines that help the immune system fight cancer), CD137 agonists (a type of drug that stimulates the immune system), or chemotherapy (medicine used to kill cancer cells).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Istituto Oncologico Veneto Padua Italy
Centre Hospitalier Universitaire Rouen Rouen France
Centrul De Oncologie-Euroclinic S.R.L. Iasi Romania
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Algemeen Ziekenhuis Delta Roeselare Belgium
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj Cluj Napoca Romania
Katholisches Klinikum Bochum gGmbH Bochum Germany
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opole Poland
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Mazowiecki Szpital Onkologiczny Sp. z o.o. Wieliszew Poland
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Institutul Regional De Oncologie Iasi Iasi Romania
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Marien Hospital Duesseldorf GmbH Duesseldorf Germany
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Nantes Nantes France
Muenchen Klinik gGmbH Munich Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Lux Med Onkologia Sp. z o.o. Warsaw Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej Jelenia Gora Poland
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Haematologisch Onkologische Praxis Eppendorf Hamburg Germany
Fundeni Clinical Institute Bucharest Romania
Cpnnvjmak Uehnrsgdalgzto Sfmhimitg Woluwe-Saint-Lambert Belgium
Ohmltvmhdsalvl Lhsl Gelj Linz Austria
Uqlaundcekwr Mqssnzr Coqivev Gtllxixky Groningen The Netherlands
Ukwmjsqgdz Os Apuwikn Edegem Belgium
Otafhddh Gbceykcqx Catania Italy
Fviekzzo nonjtswwn Miwdj a Hccqysa Prague Czechia
Choqrt Hikkwxbleny Uxfeknrevmrhc Da Dyprp Dijon France
Axpidjojt Udb Amsterdam The Netherlands
Agtyuzkqke Pdnohjsp Hpvevlbs Du Mvrvcalov Marseille France
Sro Eifyghhym Hkvqlssg Txakihj Tilburg The Netherlands
Pgjzvgpme Imcizmum Mqrmcote Mpsopbvpingu Scsef Wzwpeeedkqlf I Acwsadrtsjjbf Warsaw Poland
Nzqleqgv Itetzwbn Oirdpfecf Ipt Mkfqo Sdpaqlqgnnaubpkglrxhqjjaerev Iinxbvop Bqvifsjx Cracow Poland
Axieose Ugu Iamex Dq Rwlsiu Expwfx Reggio Emilia Italy
Hwqmvkax Uaiiujcziztzf Hmmjvdwm Tsfrt y Prpxjj Idkmybse Coruuu dbfecmqrkmdxovley (ezzy Badalona Spain
Hgxhgqwa Viiq dmvlyrqa Barcelona Spain
Isdqvjaa Pbpjnkqzrryjpnk Cmpdnh Cumyox Marseille France

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
04.02.2026
Belgium Belgium
Recruiting
04.02.2026
Czechia Czechia
Recruiting
04.02.2026
France France
Recruiting
04.02.2026
Germany Germany
Recruiting
04.02.2026
Italy Italy
Recruiting
04.02.2026
Poland Poland
Recruiting
04.02.2026
Romania Romania
Recruiting
04.02.2026
Spain Spain
Recruiting
04.02.2026
Sweden Sweden
Not yet recruiting
04.02.2026
The Netherlands The Netherlands
Not yet recruiting
04.02.2026

Trial locations

Pumitamig is a medication being tested in this study to see how well it works when combined with other cancer treatments. It is given through an IV infusion.

Oxaliplatin is a type of chemotherapy medicine used to treat cancer. It is administered as a solution through an IV infusion.

Calcium folinate is a medication used alongside certain chemotherapy drugs to help manage how the body reacts to the treatment or to improve its effectiveness. It is given as an injection.

Fluorouracil is a common chemotherapy drug used to treat various types of cancer. It is administered as a solution through an IV injection or infusion.

Capecitabine is a chemotherapy medication that is taken by mouth in pill form.

Irinotecan is a chemotherapy drug used to treat cancer. It is administered as a solution through an IV infusion.

Bevacizumab is a medication used as a comparison in this study to see how the new treatment performs against current standard care. It is given through an IV infusion.

Colorectal cancer – This disease occurs when abnormal cells form in the colon or the rectum. These cells grow uncontrollably and can form a mass known as a tumor. As the condition progresses, the cancer cells may spread from their original location to nearby tissues or distant organs in the body. In some cases, the tumor becomes difficult to remove through surgery. The disease can also present in a state where it has already moved to other parts of the body.

Trial ID:
2025-523224-45-00
Protocol code:
CA2660003
Trial Phase:
Therapeutic use (Phase IV)

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