Study of Rinatabart Sesutecan with glatiramer acetate in patients with advanced gastrointestinal cancers

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What is this study about?

The study focuses on Gastrointestinal Cancers, a group of cancers that affect the stomach, intestines, pancreas, bile ducts, and esophagus. Specific types included are metastatic colorectal cancer, where the disease has spread beyond the original site; gastric/gastroesophageal junction cancer, which starts in the stomach or where the stomach meets the esophagus; esophageal adenocarcinoma, a cancer of the lower esophagus; pancreatic ductal adenocarcinoma, a common form of pancreatic cancer; biliary tract cancer, affecting the tubes that carry bile; and esophageal squamous cell carcinoma, a cancer of the upper esophagus. The investigational medicine is Rinatabart Sesutecan (Rina‑S), which is given by an intravenous infusion, meaning the drug is delivered directly into a vein through a thin tube.

The purpose of the study is to assess the antitumor activity and safety of Rinatabart Sesutecan in participants with these advanced cancers. Participants will receive the study drug at regular intervals while being monitored through clinic visits, blood tests, and imaging scans to check for changes in tumor size and to record any side effects, known as adverse events. The study follows a schedule that spans several months, allowing researchers to observe how the cancer responds over time and to gather information on the medication’s tolerability.

1 baseline assessments

after joining the study, initial medical tests are performed to record the current health status, including scans, blood tests, and physical examination.

these assessments create a reference point to compare future changes during the trial.

2 start of rinatabart sesutecan infusion

the study drug, rinatabart sesutecan, is given by intravenous infusion, which means it is delivered directly into a vein through a drip.

the dose is calculated based on body surface area at 0.0 mg/m2 and is administered as a single infusion on the first day of each treatment cycle.

the infusion is performed in a clinical setting under the supervision of medical staff.

3 pegfilgrastim supportive injection

as background supportive care, a subcutaneous injection of pegfilgrastim is given.

the dose listed in the protocol is 00 mg, administered under the skin shortly after the infusion, according to the study schedule.

4 regular monitoring visits

following each treatment cycle, scheduled visits are required to evaluate response to therapy and check for side effects.

these visits include repeat imaging studies, blood work, and physical examinations.

any adverse events are recorded and reported to the study team.

5 continuation of treatment cycles

the cycle of intravenous infusion of rinatabart sesutecan and subcutaneous injection of pegfilgrastim repeats according to the protocol until disease progression, unacceptable toxicity, or completion of the planned number of cycles.

the exact number of cycles is determined by the investigator based on individual response and safety.

6 final evaluation

at the end of the study period or when treatment is stopped, a final set of assessments is performed to document the overall outcome.

this includes imaging to determine tumor response, final safety evaluations, and collection of any remaining study data.

Who Can Join the Study?

  • Participant must have a gastrointestinal cancer that has been confirmed by a laboratory test looking at the cancer cells (histologically or cytologically confirmed).
  • Participant must have cancer that has spread to other parts of the body or cannot be removed by surgery (metastatic or unresectable disease) and cannot be treated with the goal of cure.
  • Participant must have tumors that can be measured on imaging scans according to a standard method called RECIST version 1.1.
  • Participant must show that the cancer has gotten worse on scans while on or after the most recent treatment (radiological disease progression).
  • Participant must have an ECOG performance status of 0 or 1, meaning they are fully active or have only minor symptoms but can still carry out most daily activities.
  • Participant must be expected to live at least three months (life expectancy ≥3 months).
  • Participant must be able to provide a newly obtained or stored tissue sample from the tumor (tissue sample).
  • Participant must have laboratory test results showing that major organs (such as the liver, kidneys, and heart) and the bone‑marrow are working well enough (adequate organ and bone marrow function).
  • Both men and women are eligible to take part in the study.

Who Cannot Join the Study?

  • Having significant non‑malignant gastrointestinal disorders such as diarrhea that is worse than mild, ulcerative colitis, or inflammatory bowel disease (conditions that cause long‑term inflammation of the intestine).
  • Having recent serious gastrointestinal bleeding, open cancer‑related sores (ulcerations), abnormal connections between organs (fistula), collections of pus (abscess), or a recent hole (perforation) in the gut within the past 4‑6 weeks.
  • Having any other cancer (past or present) besides the study cancers, or any leftover cancer cells (residual disease) from a previously diagnosed tumor.
  • Having new or known unstable brain tumors that are getting worse (brain metastases), symptoms from cancer in the brain or spinal fluid, or a history of cancer spreading to the membranes covering the brain and spinal cord (carcinomatous meningitis, also called leptomeningeal disease).
  • Having previously received a drug that contains a topoisomerase‑1 inhibitor combined with an antibody‑drug conjugate (ADC) (a medicine that attaches a cancer‑killing drug to an antibody that seeks out cancer cells).
  • Having taken any other anticancer agent within 28 days before the first dose of the study treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Institut Gustave Roussy Villejuif France
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Hospital General Universitario De Valencia Valencia Spain
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Icqtobih Oopwrcbapg Vbkhko Padua Italy
Crbdnrcvo Urjktadopydzzs Swawwodqf Woluwe-Saint-Lambert Belgium
Iqtyxjxv Jyedk Bxqvgh Anderlecht Belgium
Igaelwaz Phonzcqorqqdygl Cmoaoe Cslucn Marseille France
Hugeghuu Vhso dgjvvtdw Barcelona Spain
Hqwuev Hsqfowba Herlev Denmark
Atqc Glbxju Oetyxbac Mewvrkbyxyhbv Nnqtuyck Milan Italy
Awxgtxktc Uak Amsterdam The Netherlands
Hnnsmire Cdopndy San Ctclmx Madrid Spain
Usoqdtxllk Havogtiz Mampwnazmt Maastricht The Netherlands
Rtqqozdmgpdeup Copenhagen Denmark
Ckkwgw Ldux Bhisds Lyon France
Cxmcou Rsnrmdbh Cncwvsjn Dj Vfwxkn Sunwiz Verona Italy
Chtsan Hduuoiblbwq Uujzhjqvjsbxo Du Pthuiehd Poitiers France
Hoyochgr Uehjactnapprz 1i Dm Otjjzzx Madrid Spain
Hjcieaab Uuwmifirrevze Meqopdc De Vqdjaqflsz Santander Spain
Aqerj Gutmlxzie Ds Czxhwgu Catania Italy
Hmuocby Dq Lbfmxzmid Libramont-Chevigny Belgium
Fhrvnypvss Ipwcwqdajt Izggchjc Njkcdieuaaf Beqne Milan Italy

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.09.2026
Denmark Denmark
Not yet recruiting
01.09.2026
France France
Not yet recruiting
01.09.2026
Italy Italy
Not yet recruiting
01.09.2026
Spain Spain
Not yet recruiting
01.09.2026
The Netherlands The Netherlands
Not yet recruiting
01.09.2026

Trial locations

Rinatabart Sesutecan is an experimental medication being tested in this study. It is given through an intravenous infusion, which means it is delivered directly into a vein over a period of time. The drug is being studied as a single‑agent treatment (monotherapy) to see if it can shrink or stop the growth of advanced gastrointestinal cancers, such as colorectal, stomach, esophageal, pancreatic, and biliary tract cancers. Researchers are looking at how well the drug works against tumors and whether it is safe for patients.

PEGFILGRASTIM is a background medication used in the trial to support the patients’ blood cells. It is given as a subcutaneous injection (injected under the skin) and works by stimulating the body’s production of certain white blood cells, helping to reduce the risk of low blood counts that can occur during cancer treatment. This support allows patients to stay on the study therapy with fewer interruptions due to blood‑related side effects.

Metastatic colorectal cancer – This cancer starts in the colon or rectum and has spread to other parts of the body. Tumor cells can travel through the blood or lymph system to reach distant organs. As the disease progresses, new tumor sites may appear, increasing the overall tumor burden. The spread often leads to symptoms related to the affected organs. Monitoring the size and number of tumors helps assess disease activity.

Gastric and gastroesophageal junction cancer – This malignancy arises in the stomach lining or at the area where the esophagus meets the stomach. Cancer cells can grow outward, infiltrating nearby tissues and lymph nodes. Over time, they may extend into the abdominal cavity or spread through the bloodstream. The disease often presents with changes in appetite or digestion. As it advances, multiple tumor sites can develop.

Esophageal adenocarcinoma – This tumor originates from glandular cells in the lower part of the esophagus. It tends to grow inward, narrowing the esophageal tube and can extend into surrounding structures. Cancer cells may enter the lymphatic system and travel to distant organs. The disease can cause difficulty swallowing and weight loss as it expands. Continued growth leads to additional metastatic sites.

Pancreatic ductal adenocarcinoma – This cancer begins in the ducts that carry digestive enzymes within the pancreas. It typically infiltrates the surrounding pancreatic tissue and nearby blood vessels. Tumor cells can spread to the liver, lungs, or peritoneal cavity through blood or lymph channels. Early growth may cause vague abdominal discomfort. As it progresses, multiple organ involvement becomes common.

Biliary tract cancer – This malignancy develops in the bile ducts that drain bile from the liver to the intestine. The tumor can block bile flow and invade surrounding liver tissue. Cancer cells may travel to lymph nodes and distant organs such as the lungs. Disease advancement often results in additional tumor deposits throughout the abdomen.

Esophageal squamous cell carcinoma – This cancer originates from the flat cells lining the upper and middle parts of the esophagus. It grows outward, thickening the esophageal wall and can spread to nearby lymph nodes. Cancer cells may enter the bloodstream and form new tumors in distant sites. The disease frequently causes swallowing difficulties as it enlarges. Ongoing spread leads to multiple metastatic lesions.

Trial ID:
2025-524130-26-00
Protocol code:
GCT1184-09
NCT ID:
NCT07539311
Trial Phase:
Therapeutic exploratory (Phase II)

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