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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

9 criteria

  • 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 trial?

6 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

  • Rinatabart Sesutecan

    This drug is given as a sterile solution that is infused into a vein. It is still experimental and is being tested in a Phase 2 trial for advanced gastrointestinal cancers, so it is not yet approved or widely described in medical literature. The main goal is to see if it can shrink or stop the growth of tumors in the digestive system. It works by targeting specific molecules that help cancer cells grow, and it is classified as an investigational anti‑cancer agent.

  • PEGFILGRASTIM

    This medication is injected just under the skin as a subcutaneous injection. It is an approved drug that is used to help the body make more white blood cells after chemotherapy, and it is well described in medical references. Its primary use is to lower the risk of infection by increasing neutrophil counts in patients receiving cancer treatment. It works by attaching to receptors on bone‑marrow cells, telling them to produce more neutrophils, and it belongs to the class of colony‑stimulating factors.

Investigated diseases

  • 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524130-26-00Protocol codeGCT1184-09Estimated enrolment160 patientsSponsorGenmab A/S

sourced from the EU Clinical Trials Register and site verification

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