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Study of DKN-01 and Tislelizumab with Chemotherapy for Adults with Advanced Gastric or Gastroesophageal Cancer

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What is this study about?

This clinical trial is focused on studying treatments for gastric cancer, specifically a type called gastric adenocarcinoma, which can also affect the area where the stomach meets the esophagus, known as the gastroesophageal junction. The study is exploring the use of a new treatment combination involving a medication called DKN-01 and another medication named Tislelizumab. These treatments may be used alone or together with chemotherapy, which is a type of cancer treatment that uses drugs to destroy cancer cells. The chemotherapy drugs being studied include Capecitabine and Oxaliplatin, which are often used together in a regimen called CAPOX, as well as a combination known as mFOLFOX6, which includes leucovorin calcium, fluorouracil, and oxaliplatin.

The purpose of this study is to understand how safe and tolerable these treatment combinations are for patients with advanced stages of gastric cancer that cannot be removed by surgery. The study will also look at whether adding DKN-01 to the treatment improves the time patients live without the cancer getting worse, which is known as progression-free survival. The study is divided into different parts, with some patients receiving the new treatment combinations as their first treatment and others receiving it after previous treatments have not worked.

Participants in the study will receive the treatments through an intravenous method, which means the medication is given directly into a vein. The study will last for a period of up to 24 months, during which time the safety and effects of the treatments will be closely monitored. The study aims to provide valuable information on the potential benefits of these new treatment combinations for patients with advanced gastric cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, physical examination, and necessary laboratory tests.

The assessment ensures that the patient meets the criteria for participation, such as having a specific type of gastric or gastroesophageal cancer and acceptable organ function.

2 treatment plan discussion

The treatment plan is discussed, including the medications involved and their administration methods. The study involves a combination of DKN-01 and tislelizumab, with or without chemotherapy.

Chemotherapy may include capecitabine and oxaliplatin (CAPOX regimen) or leucovorin calcium, fluorouracil, and oxaliplatin (mFOLFOX6 regimen).

3 treatment administration

The treatment is administered in cycles. DKN-01 and tislelizumab are given through intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

Capecitabine is taken orally in the form of tablets, while oxaliplatin and fluorouracil are also administered intravenously.

4 monitoring and follow-up

Regular monitoring is conducted to assess the patient’s response to treatment and to identify any side effects. This includes physical exams, blood tests, and imaging studies.

The frequency of these assessments is determined by the study protocol and is essential for ensuring patient safety and evaluating the effectiveness of the treatment.

5 completion of treatment

Upon completion of the treatment cycles, a final assessment is conducted to evaluate the overall response to the therapy.

Patients may continue to be monitored for a period after the treatment to track long-term effects and outcomes.

Who Can Join the Study?

  • Must have a diagnosis of gastric adenocarcinoma or Siewert I-III GEJ adenocarcinoma.
  • Must be at least 18 years old (19 years old in the Republic of Korea).
  • Must be able to provide written consent and agree to follow the study requirements.
  • Must have acceptable kidney function as shown by specific blood tests.
  • Must have acceptable blood health, meaning enough white blood cells, platelets, and hemoglobin.
  • Must have acceptable liver function as shown by specific blood tests.
  • Must have acceptable blood clotting ability, unless on blood-thinning medication.
  • Must have an ECOG performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must have at least one measurable tumor as seen on imaging tests.
  • Must provide a tumor sample for evaluation, either a new biopsy or an archived specimen.
  • Females who can have children must use effective birth control during the study and for 6 months after, and have a negative pregnancy test before starting the study.
  • Males who are not sterile must use effective birth control during the study and for 6 months after.
  • For Part A and C: Must not have had previous systemic therapy for inoperable or advanced cancer, except if prior treatment was completed without disease return for at least 6 months.
  • For Part B: Must have documented disease progression after first-line therapy with specific drugs for advanced cancer.
  • For Part B: Must have high levels of DKK1 mRNA in tumor cells from a biopsy.
  • For Part C: Must have documentation of PD-L1 CPS and DKK1 mRNA expression in tumor cells from a biopsy.

Who Cannot Join the Study?

  • Patients with any other type of cancer besides gastric cancer, gastric adenocarcinoma, or gastroesophageal cancer cannot participate.
  • Patients who have had previous treatment with the study drugs DKN-01 or tislelizumab are not eligible.
  • Patients with severe allergies or reactions to the study drugs or similar drugs cannot join the study.
  • Patients with uncontrolled medical conditions that could interfere with the study treatment are excluded.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Patients who are unable to follow the study procedures or attend study visits are not eligible.
  • Patients with a history of certain heart conditions or diseases affecting the heart are excluded.
  • Patients with active infections that require treatment are not eligible.
  • Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body, are excluded.
  • Patients who have received another investigational drug within a certain period before the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Haematologisch Onkologische Praxis Eppendorf Hamburg Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany

Other Sites

Site Name City Country Status
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Krankenhaus Nordwest GmbH Frankfurt Germany
Caritas Traegergesellschaft Saarbruecken mbH (CTS) Saarbrücken Germany
Deutsches Herzzentrum Berlin Berlin Germany
Studienzentrum Onkologie Ravensburg GmbH Ravensburg Germany

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

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
30.09.2023

Trial locations

Investigated drugs:

DKN-01 is a medication being studied for its potential to help treat certain types of stomach cancer. It is being tested to see if it can work together with other treatments to improve outcomes for patients. The goal is to see if DKN-01 can help slow down the growth of cancer cells when used with other therapies.

Tislelizumab is a type of medication known as an immunotherapy. It works by helping the body’s immune system recognize and fight cancer cells more effectively. In this study, it is being used to see if it can help improve the treatment of stomach cancer when combined with other medications.

CAPOX is a combination of two chemotherapy drugs, capecitabine and oxaliplatin. These drugs work together to kill cancer cells or stop them from growing. In this trial, CAPOX is being used to see if it can enhance the effectiveness of other treatments for stomach cancer.

mFOLFOX6 is another combination of chemotherapy drugs, including leucovorin calcium, fluorouracil, and oxaliplatin. This combination is used to attack cancer cells and prevent them from multiplying. The study is exploring whether mFOLFOX6 can improve treatment results when used with other therapies for stomach cancer.

Investigated diseases:

Gastric Cancer – Gastric cancer is a disease where malignant cells form in the lining of the stomach. It often begins in the mucus-producing cells that line the stomach, known as adenocarcinoma. The disease progresses as the cancer cells grow and invade deeper layers of the stomach wall. Over time, it can spread to nearby lymph nodes and other organs. The progression can lead to symptoms such as stomach pain, nausea, and weight loss. As the disease advances, it may affect the stomach’s ability to function properly.

Gastric Adenocarcinoma – Gastric adenocarcinoma is a type of cancer that originates in the glandular cells of the stomach lining. It is the most common form of stomach cancer. The disease progresses as the cancerous cells multiply and invade the stomach wall and surrounding tissues. This can lead to symptoms like difficulty swallowing, feeling full after small meals, and gastrointestinal bleeding. As it advances, the cancer may spread to lymph nodes and distant organs. The progression can disrupt normal digestive processes and cause significant discomfort.

Gastroesophageal Cancer – Gastroesophageal cancer refers to malignancies that occur at the junction of the stomach and esophagus. It often involves adenocarcinoma, which starts in the glandular cells of this region. The disease progresses as cancer cells grow and invade the esophagus, stomach, and nearby structures. Symptoms may include difficulty swallowing, chest pain, and regurgitation. As the cancer advances, it can spread to lymph nodes and other parts of the body. The progression can lead to significant challenges in eating and digestion.

Trial ID:
2023-504940-32-00
Protocol code:
DEK-DKK1-P205
NCT ID:
NCT04363801
Trial Phase:
Therapeutic exploratory (Phase II)

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