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Study on the Safety and Effects of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in Patients with Advanced or Metastatic Solid Tumors

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

This clinical trial is focused on studying certain types of cancer that are difficult to remove through surgery or have spread to other parts of the body. These cancers include clear cell renal cell carcinoma (a type of kidney cancer), pancreatic ductal adenocarcinoma (a type of pancreatic cancer), and colorectal cancer (cancer of the colon or rectum). The study is testing two new treatments: Debio 0328 and Debio 0228. Debio 0328 is given as a solution for injection, and Debio 0228 is given as a solution for infusion. Both treatments are administered through a vein.

The purpose of the study is to evaluate the safety and effectiveness of these treatments. The study is divided into three parts. In the first part, participants will receive a single dose of Debio 0328 to assess its safety and how well it can help in imaging the tumors. In the second part, the study will determine the best dose of Debio 0228 for each type of cancer. The third part will explore the potential of Debio 0228 to reduce the size of the tumors. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatments.

Throughout the study, participants will be closely monitored for any side effects and changes in their health. The study aims to gather information on how the body absorbs and processes these treatments, as well as their impact on the tumors. This research could provide valuable insights into new ways to treat these challenging cancers.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Part A: Initial Evaluation
Receive a single intravenous administration of [68Ga]Ga-DPI-4452.
Undergo imaging to assess the uptake of the radiotracer in normal organs and tumor lesions.
Monitor vital signs and undergo electrocardiogram (ECG) assessments.
Provide blood and urine samples for analysis of radioactivity levels.
Step 2
Part B: Dose Determination
Receive intravenous administration of [177Lu]Lu-DPI-4452.
Monitor for any dose-limiting toxicities and assess overall safety.
Undergo imaging to evaluate the absorption of radioactivity in organs and tumor lesions.
Provide blood and urine samples for pharmacokinetic analysis.
Step 3
Part C: Efficacy Evaluation
Continue receiving [177Lu]Lu-DPI-4452 as determined in Part B.
Assess the preliminary antitumor activity through imaging and clinical evaluations.
Monitor for any adverse events and changes in laboratory values.
Provide additional blood and urine samples for further analysis.

Who can join the trial?

16 criteria

For Part A, the patient must have a confirmed diagnosis of a type of cancer that cannot be removed by surgery and has spread locally or to other parts of the body. This includes clear cell renal cell carcinoma (ccRCC), pancreatic ductal adenocarcinoma (PDAC), or colorectal cancer (CRC).
For Part A, the patient must have a disease that can be measured using specific medical guidelines called RECIST v1.1.
For Part A, the patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, which is a scale used to assess how the disease affects the patient's daily living abilities.
For Part A, the patient must have enough healthy bone marrow and organ function, as shown by blood and urine tests.
For Part A, the patient must have adequate blood counts, including hemoglobin of at least 8 g/dL, an absolute neutrophil count (ANC) of at least 1.0 x 10⁹/L, and platelets of at least 50 x 10⁹/L.
For Part A, the patient must have adequate liver function, with specific enzyme levels not exceeding certain limits, and bilirubin levels within a safe range.
For Part A, the patient must have adequate kidney function, with an estimated glomerular filtration rate (eGFR) above 50 mL/min/1.73 m² for PDAC and CRC patients, and above 40 mL/min/1.73 m² for ccRCC patients.
For Parts B and C, the patient must have a confirmed diagnosis of a type of cancer that is progressing, cannot be removed by surgery, and has spread locally or to other parts of the body. This includes ccRCC, PDAC, or CRC.
For Parts B and C, the patient must have a disease that can be measured using specific medical guidelines called RECIST v1.1.
For Parts B and C, the patient must have an ECOG performance status of 0-1.
For Parts B and C, the patient must have a life expectancy of more than 6 months.
For Parts B and C, the patient must have enough healthy bone marrow and organ function, as shown by blood and urine tests.
For Parts B and C, the patient must have adequate blood counts, including hemoglobin of at least 9 g/dL, an ANC of at least 1.5 x 10⁹/L, and platelets of at least 100 x 10⁹/L.
For Parts B and C, the patient must have adequate liver function, with specific enzyme levels not exceeding certain limits, and bilirubin levels within a safe range.
For Parts B and C, the patient must have adequate kidney function, with an eGFR above 50 mL/min/1.73 m² for PDAC and CRC patients, and above 40 mL/min/1.73 m² for ccRCC patients.
For Parts B and C, the patient must have adequate blood clotting ability, with specific test results within safe limits and no history of major bleeding or clotting events in the past 6 months.

Who cannot join the trial?

9 criteria

Patients with tumors that can be surgically removed cannot participate.
Patients with medical conditions other than the specified types of cancer cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are not able to give informed consent cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with certain medical conditions that might interfere with the study cannot participate.
Patients who have received certain treatments recently that might interfere with the study cannot participate.
Patients with allergies to the study medication cannot participate.
Patients who are participating in another clinical trial cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

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Investigated drugs

[68Ga]Ga-DPI-4452
is a medication used in this clinical trial to help doctors see tumors more clearly during imaging tests. It is given through an intravenous (IV) injection and helps to highlight the tumors in the body, making it easier for doctors to assess the size and location of the tumors.
[177Lu]Lu-DPI-4452
is another medication used in the trial, aimed at treating patients with advanced or metastatic solid tumors. This medication is also administered through an IV injection and is being studied for its ability to reduce the size of tumors and improve patient outcomes. The trial is evaluating how well this medication works and how safe it is for patients.

What is already known about the treatment

[68Ga]Ga-DPI-4452
This medication is administered intravenously and is currently being studied in clinical trials to evaluate its safety, tolerability, and imaging characteristics in patients with unresectable locally advanced or metastatic solid tumors, including clear cell renal cell carcinoma, pancreatic ductal adenocarcinoma, and colorectal cancer. It is not yet approved for general medical use. The main therapeutic indication is for imaging purposes to help visualize tumors. The mechanism of action involves binding to specific targets on tumor cells, allowing for enhanced imaging. It is classified as a radiopharmaceutical agent.
[177Lu]Lu-DPI-4452
This medication is also administered intravenously and is under investigation in clinical trials to assess its safety, tolerability, and preliminary antitumor activity in patients with the same types of tumors as [68Ga]Ga-DPI-4452. It is not yet approved for general medical use. The main therapeutic indication is for the treatment of certain solid tumors. The mechanism of action involves delivering targeted radiation to tumor cells, which can help reduce tumor size. It is classified as a radiopharmaceutical therapeutic agent.

Investigated diseases

Clear Cell Renal Cell Carcinoma
This is a type of kidney cancer that originates in the lining of the small tubes in the kidney. It is characterized by the presence of clear cells when viewed under a microscope. The disease often progresses by forming a mass in the kidney, which can grow and potentially spread to other parts of the body. As it advances, it may cause symptoms such as blood in the urine, pain in the side, or a lump in the abdomen. The progression can vary, with some tumors growing slowly while others may spread more rapidly.
Pancreatic Ductal Adenocarcinoma
This is the most common type of pancreatic cancer, originating in the ducts of the pancreas. It typically progresses by forming a tumor that can obstruct the bile duct, leading to jaundice. As the disease advances, it may invade nearby tissues and organs, and potentially spread to distant sites. Symptoms often include abdominal pain, weight loss, and digestive issues. The progression can be aggressive, with the cancer often spreading before it is detected.
Colorectal Cancer
This cancer begins in the colon or rectum, parts of the large intestine. It usually starts as a growth called a polyp on the inner lining, which can become cancerous over time. The disease progresses by invading deeper layers of the bowel wall and potentially spreading to nearby lymph nodes and other organs. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression can vary, with some cancers growing slowly and others spreading more quickly.