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68Ga-Dpi-4452

This article discusses the ongoing clinical trials of 68Ga-DPI-4452, a novel radiopharmaceutical being studied for its potential in diagnosing and treating advanced or metastatic solid tumors. The trials aim to assess the safety, tolerability, and imaging characteristics of 68Ga-DPI-4452, as well as the safety, tolerability, and efficacy of its therapeutic counterpart, 177Lu-DPI-4452, in patients with specific types of cancer, including clear cell renal cell carcinoma, pancreatic ductal adenocarcinoma, and colorectal cancer.

Table of Contents

What is 68Ga-DPI-4452?

68Ga-DPI-4452 is an investigational drug being studied for its potential use in patients with advanced or metastatic solid tumors. It is classified as a radiopharmaceutical, which means it contains a radioactive substance used for diagnostic or therapeutic purposes in medicine[1]. The drug is also known by its product name “Debio 0328” and is being developed by Debiopharm[1].

How does 68Ga-DPI-4452 work?

68Ga-DPI-4452 is designed to target a specific protein called Carbonic Anhydrase IX (CA IX). This protein is often found in higher amounts in certain types of cancer cells. The drug combines a targeting molecule that seeks out CA IX with a radioactive element (Gallium-68). This combination allows doctors to see where the drug accumulates in the body, potentially highlighting areas where cancer is present[1].

What conditions does 68Ga-DPI-4452 treat?

The clinical trial is investigating the use of 68Ga-DPI-4452 in patients with the following types of advanced or metastatic solid tumors:

  • Clear cell renal cell carcinoma (ccRCC): A type of kidney cancer
  • Pancreatic ductal adenocarcinoma (PDAC): A type of pancreatic cancer
  • Colorectal Cancer (CRC): Cancer that starts in the colon or rectum

These cancers are considered “unresectable locally advanced or metastatic,” which means they cannot be completely removed by surgery and may have spread to other parts of the body[1].

Clinical Trial Overview

The clinical trial for 68Ga-DPI-4452 is a Phase 1/2 study, which means it’s in the early stages of testing in humans. The trial has multiple parts:

  • Part A: This part focuses on evaluating the safety and how well the body tolerates a single dose of 68Ga-DPI-4452[1].
  • Part B: This part aims to determine the best dose of a related drug called 177Lu-DPI-4452 for each type of cancer being studied[1].
  • Part C: This part will look at how effective 177Lu-DPI-4452 is at fighting the cancer[1].

Who can participate in the trial?

The trial has specific criteria for who can participate. Some key points include:

  • Patients must have confirmed advanced or metastatic ccRCC, PDAC, or CRC[1].
  • Patients must have measurable disease according to specific criteria (RECIST v1.1)[1].
  • Patients must have adequate bone marrow, liver, and kidney function[1].
  • For Parts B and C, patients must have a life expectancy of more than 6 months[1].

There are also several factors that would prevent someone from participating, such as certain medical conditions or previous treatments[1].

What to expect during the trial

During the trial, participants will receive 68Ga-DPI-4452 through an intravenous (IV) injection, which means it’s given directly into a vein. Depending on which part of the trial they’re in, participants may also receive 177Lu-DPI-4452[1].

Throughout the study, doctors will monitor participants closely. They will perform various tests and scans to see how the drug is working and to check for any side effects. These may include:

  • Blood and urine tests
  • PET/CT scans (a type of imaging that can show where the drug is in the body)
  • Monitoring of vital signs and heart activity (ECG)
  • Assessments of how the tumor is responding to treatment

Potential Benefits and Risks

As with any clinical trial, there are potential benefits and risks to participating:

Potential Benefits:

  • Access to a new treatment that may be effective against your cancer
  • Close monitoring by healthcare professionals
  • Contributing to medical research that may help future patients

Potential Risks:

  • Side effects from the drug, which are not yet fully known
  • The treatment may not be effective for your cancer
  • Time commitment for study visits and procedures

It’s important to discuss these potential benefits and risks with your doctor and the study team before deciding to participate in any clinical trial[1].

Aspect Details
Study Type Phase 1/2, multicenter, open-label, non-randomized
Investigational Drugs [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452
Target Conditions Unresectable locally advanced or metastatic solid tumors (ccRCC, PDAC, CRC)
Primary Objectives Evaluate safety, tolerability, imaging characteristics, and efficacy
Key Eligibility Criteria Confirmed diagnosis, measurable disease, adequate organ function
Primary Endpoints Adverse events, dose-limiting toxicities, objective response rate
Secondary Endpoints Pharmacokinetics, dosimetry, tumor uptake, progression-free survival

FAQ

  • What is 68Ga-DPI-4452? 68Ga-DPI-4452 is a radiopharmaceutical being studied for its potential in diagnosing advanced or metastatic solid tumors. It is used in PET imaging to help identify and locate tumor lesions in the body.
  • What types of cancer are being studied in these clinical trials? The clinical trials are focusing on patients with unresectable locally advanced or metastatic solid tumors, specifically clear cell renal cell carcinoma (ccRCC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC).
  • What are the main objectives of the clinical trials? The main objectives are to evaluate the safety and tolerability of 68Ga-DPI-4452, determine the optimal dose of 177Lu-DPI-4452, and assess the preliminary anti-tumor activity of 177Lu-DPI-4452 in patients with advanced solid tumors.
  • How is 68Ga-DPI-4452 administered to patients? 68Ga-DPI-4452 is administered to patients through intravenous (IV) injection. This allows the radiopharmaceutical to circulate throughout the body and accumulate in tumor tissues for imaging purposes.
  • What are some of the key eligibility criteria for participating in these trials? Key eligibility criteria include having a confirmed diagnosis of one of the specified tumor types, measurable disease according to RECIST v1.1 criteria, adequate organ function, and meeting specific performance status requirements. Patients must also not have certain medical conditions or prior treatments that could interfere with the study.

Ongoing Clinical Trials on 68Ga-Dpi-4452

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

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France

Glossary

  • Radiopharmaceutical: A drug that contains a radioactive substance used for diagnosing or treating diseases, including cancer.
  • PET imaging: Positron Emission Tomography, a type of medical imaging that uses small amounts of radioactive materials to diagnose or evaluate the treatment of various diseases, including cancer.
  • Metastatic: Cancer that has spread from its original location to other parts of the body.
  • Unresectable: Tumors that cannot be completely removed through surgery.
  • Clear cell renal cell carcinoma (ccRCC): A type of kidney cancer that begins in the cells lining the small tubes in the kidneys.
  • Pancreatic ductal adenocarcinoma (PDAC): The most common type of pancreatic cancer, which starts in the ducts of the pancreas.
  • Colorectal Cancer (CRC): Cancer that starts in the colon or rectum, parts of the large intestine.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or require a dose reduction.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Dosimetry: The measurement and calculation of radiation doses in various parts of the body.
  • SUVmax/SUVmean: Standardized Uptake Value (maximum or mean), a measure of how much radiotracer is taken up by tissue in PET imaging.
  • SPECT/CT: Single Photon Emission Computed Tomography combined with Computed Tomography, an imaging technique that provides both functional and anatomical information.
  • Immunohistochemistry (IHC): A method used to detect specific proteins in tissues, often used to diagnose certain types of cancer.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-68gaga-dpi-4452-and-177lulu-dpi-4452-in-patients-with-advanced-or-metastatic-solid-tumors/