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Study on Ifinatamab Deruxtecan for Patients with Recurrent or Metastatic Solid Tumors

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the effects of a new treatment called Ifinatamab deruxtecan, also known by its code name DS-7300a. This treatment is being tested on various types of cancers that have either come back or spread to other parts of the body. These cancers include endometrial cancer, head and neck squamous cell carcinoma, pancreatic cancer, colorectal cancer, liver cancer, esophageal and stomach cancer, bladder cancer, ovarian cancer, cervical cancer, biliary tract cancer, HER2-low breast cancer, HER2 IHC 0 breast cancer, and cutaneous melanoma. The purpose of the study is to evaluate how effective and safe Ifinatamab deruxtecan is for patients with these types of cancers.

Participants in the study will receive the treatment as a solution for infusion, which means it will be given through a vein. The study will observe how the treatment affects the cancer and monitor any side effects. The trial will include regular check-ups and assessments to track the progress of the treatment. The study aims to understand how well the treatment works in shrinking the tumors and how safe it is for the patients.

The study will continue for several years, with the goal of gathering enough information to determine the treatment's effectiveness and safety. This research is important for developing new ways to treat these challenging cancers and could potentially lead to new treatment options for patients in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, an initial visit is scheduled. During this visit, a healthcare professional will explain the study details, including the purpose, procedures, and potential risks and benefits.

    A series of tests and assessments will be conducted to confirm eligibility. These may include blood tests, imaging scans, and a review of medical history.

  2. Step 2

    Treatment administration

    The treatment involves the administration of ifinatamab deruxtecan, a medication given as a solution for infusion. This means it is delivered directly into the bloodstream through a vein.

    The infusion is scheduled at regular intervals, as determined by the study protocol. The healthcare team will provide specific instructions on the frequency and duration of each infusion session.

  3. Step 3

    Regular monitoring

    Throughout the study, regular monitoring visits are required. These visits are essential to track the body's response to the treatment and to ensure safety.

    During these visits, various assessments will be conducted, including physical exams, blood tests, and imaging scans. The healthcare team will also inquire about any side effects or changes in health status.

  4. Step 4

    Follow-up visits

    After completing the treatment phase, follow-up visits are scheduled. These visits help evaluate the long-term effects of the treatment and monitor overall health.

    The frequency and duration of follow-up visits will be communicated by the healthcare team, and they may include similar assessments as during the treatment phase.

  5. Step 5

    End of study

    At the end of the study, a final visit is conducted. This visit includes a comprehensive evaluation of health status and a discussion of the study's outcomes.

    Participants will receive information about any further steps or recommendations based on the study results and their individual health needs.

Who can join the trial?

9 criteria

  • Participants must be at least 18 years old.
  • Participants must have a type of cancer that is recurrent (comes back) or metastatic (has spread to other parts of the body).
  • Participants must have at least one measurable lesion (an area of cancer that can be measured) on a CT or MRI scan.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest.
  • Participants must have adequate organ function, which includes specific requirements for blood counts, liver function, and kidney function.
  • Participants must have documented disease progression (worsening of cancer) after previous treatments.
  • Participants must not have received certain types of cancer treatments before, such as topoisomerase I inhibitors (a type of chemotherapy).
  • Participants with specific types of cancer must have received prior treatments, such as platinum-based therapy or immune checkpoint inhibitors (ICIs), unless they are ineligible for these treatments.
  • Participants with certain genetic mutations in their tumors must have been treated with targeted therapy before joining the study.

Who cannot join the trial?

5 criteria

  • Patients with **recurrent** (cancer that has come back) or **metastatic** (cancer that has spread to other parts of the body) solid tumors cannot participate.
  • Patients with specific types of cancer such as endometrial cancer, head and neck squamous cell carcinoma, pancreatic ductal adenocarcinoma, colorectal cancer, hepatocellular carcinoma, adenocarcinoma of the esophagus, gastroesophageal junction, and stomach, urothelial carcinoma, ovarian cancer, cervical cancer, biliary tract cancer, HER2-low breast cancer, HER2 immunohistochemistry 0 breast cancer, and cutaneous melanoma are excluded.
  • Patients who do not have **target lesions** (specific areas of cancer that can be measured) as defined by **RECIST v1.1** (a set of rules for measuring cancer response to treatment) are not eligible.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a **vulnerable population** (groups that may need special protection) are excluded.
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Investigated drugs

Ifinatamab deruxtecan (I DXd) is a medication being studied for its potential to treat various types of solid tumors that have come back or spread to other parts of the body. It is designed to target and attach to specific proteins on the surface of cancer cells. Once attached, it delivers a powerful drug directly into the cancer cells, which may help to kill them or stop them from growing. This study aims to see how well this medication works in shrinking tumors and to check if it is safe and tolerable for patients with these types of cancers.

What is already known about the treatment

Ifinatamab deruxtecan – Ifinatamab deruxtecan is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating various types of recurrent or metastatic solid tumors, including endometrial cancer, head and neck cancer, and others. The medication works by targeting specific proteins on cancer cells, delivering a toxic substance that helps to kill these cells. It is classified as an antibody-drug conjugate, which is a type of targeted cancer therapy designed to attack cancer cells while minimizing damage to normal cells.

Investigated diseases

  • Endometrial Cancer

    Endometrial cancer originates in the lining of the uterus, known as the endometrium. It typically begins with abnormal cell growth in this lining, which can form a tumor. As the disease progresses, the cancer cells may invade the uterine wall and spread to nearby organs. In advanced stages, it can metastasize to distant parts of the body. The progression is often marked by symptoms such as abnormal vaginal bleeding or discharge.

  • Head and Neck Squamous Cell Carcinoma

    This type of cancer arises from the squamous cells lining the moist surfaces inside the head and neck. It often begins in areas such as the mouth, throat, or nose. The disease progresses by invading nearby tissues and can spread to lymph nodes in the neck. As it advances, it may affect speech, swallowing, and breathing. The progression is typically associated with symptoms like persistent sore throat, difficulty swallowing, or a lump in the neck.

  • Pancreatic Ductal Adenocarcinoma

    Pancreatic ductal adenocarcinoma is a cancer that forms in the ducts of the pancreas. It usually starts with the abnormal growth of cells in these ducts, leading to tumor formation. The disease progresses by invading nearby tissues and organs, such as the stomach and intestines. In advanced stages, it can spread to distant organs like the liver and lungs. Symptoms often include jaundice, weight loss, and abdominal pain as the disease advances.

  • Colorectal Cancer

    Colorectal cancer begins in the colon or rectum, often starting as a polyp that can become cancerous over time. The disease progresses by growing into the wall of the colon or rectum and potentially spreading to nearby lymph nodes. As it advances, it can metastasize to distant organs, such as the liver or lungs. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort.

  • Hepatocellular Carcinoma

    Hepatocellular carcinoma is a primary liver cancer that originates in the liver cells, known as hepatocytes. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis. The disease progresses by forming a tumor in the liver, which can grow and invade nearby blood vessels. In advanced stages, it may spread to other parts of the body. Symptoms can include abdominal pain, weight loss, and jaundice as the disease progresses.

  • Adenocarcinoma of Esophagus, Gastroesophageal Junction, and Stomach

    This cancer originates in the glandular cells lining the esophagus, gastroesophageal junction, or stomach. It typically begins with abnormal cell growth, forming a tumor in these areas. The disease progresses by invading deeper layers of the esophagus or stomach wall and can spread to nearby lymph nodes. In advanced stages, it may metastasize to distant organs. Symptoms often include difficulty swallowing, weight loss, and stomach pain.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509632-26-00Protocol codeDS7300-203Estimated enrolment561 patientsSponsorDaiichi Sankyo Inc.

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