#1 Clinical Trials Search in Europe

Actinium (Ac 225) Oxodotreotide

Actinium (Ac 225) Oxodotreotide, also known as RYZ101, is being investigated in clinical trials for patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This article provides an overview of the ongoing research, including the trial’s objectives, eligibility criteria, and potential benefits for patients who have progressed after previous treatments.

Table of Contents

What is ACTINIUM (AC 225) OXODOTREOTIDE?

ACTINIUM (AC 225) OXODOTREOTIDE, also known as RYZ101 or Ac-225 DOTATATE, is an innovative drug being studied for the treatment of advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs)[1]. This medication is classified as a targeted radionuclide therapy, which means it combines a radioactive element (Actinium-225) with a molecule that can specifically bind to cancer cells.

Medical Condition Treated

The primary focus of this treatment is on gastroenteropancreatic neuroendocrine tumors (GEP-NETs). These are rare tumors that form in the digestive system, including the pancreas, stomach, and intestines[1]. Specifically, this drug is being studied for patients with:

  • Inoperable, advanced GEP-NETs
  • Tumors that express somatostatin receptors (SSTR+)
  • Well-differentiated tumors (which means they grow slowly)
  • Tumors that have progressed after previous treatment with another type of radionuclide therapy (177Lu-labelled somatostatin analogue therapy)

How It Works

ACTINIUM (AC 225) OXODOTREOTIDE works by targeting specific receptors called somatostatin receptors, which are often found in high numbers on the surface of neuroendocrine tumor cells. The drug consists of two main parts:

  1. DOTATATE: This is a molecule that binds specifically to somatostatin receptors on tumor cells.
  2. Actinium-225: This is a radioactive element that delivers radiation directly to the tumor cells.
When the drug is injected into the bloodstream, it circulates throughout the body. The DOTATATE part of the drug seeks out and attaches to the somatostatin receptors on tumor cells. Once attached, the Actinium-225 emits radiation, which can damage and kill the cancer cells[1].

Current Clinical Trial

ACTINIUM (AC 225) OXODOTREOTIDE is currently being studied in a clinical trial called ACTION-1. This is a Phase 1b/3 global, randomized, controlled, open-label trial[1]. Here are some key points about the trial:

  • It compares RYZ101 (ACTINIUM (AC 225) OXODOTREOTIDE) to standard of care (SoC) therapy.
  • The trial has two parts:
    • Part 1: Focuses on determining the right dose and assessing safety.
    • Part 2: Aims to determine if RYZ101 improves progression-free survival compared to standard treatments.
  • The trial is looking at several outcomes, including overall survival, tumor response rates, and quality of life measures.

Eligibility Criteria

To participate in this clinical trial, patients must meet certain criteria. Some key eligibility factors include[1]:

  • Having a GEP-NET that has progressed after previous treatment with 177Lu-labelled somatostatin analogue therapy
  • Adequate kidney function
  • Adequate blood cell counts
  • No history of certain other cancers within the past 3 years
  • No brain metastases (in Part 2, previously treated brain metastases may be allowed under certain conditions)
There are also several exclusion criteria, such as certain cardiovascular conditions, uncontrolled diabetes, and pregnancy or breastfeeding.

How It’s Administered

ACTINIUM (AC 225) OXODOTREOTIDE is given as an intravenous (IV) injection. The maximum daily dose being studied is 10.2 MBq (megabecquerels, a unit of radioactivity), with a maximum total dose of 40.8 MBq over a treatment period of up to 32 weeks[1].

Potential Benefits

While the full benefits of ACTINIUM (AC 225) OXODOTREOTIDE are still being studied, researchers hope that it may offer several advantages over current treatments:

  • Improved progression-free survival (time without the cancer growing or spreading)
  • Better overall survival
  • Higher tumor response rates
  • Improved quality of life for patients with advanced GEP-NETs
However, it’s important to note that these potential benefits are still being evaluated in the clinical trial[1].

Safety Considerations

As with any new treatment, safety is a crucial consideration. The clinical trial is closely monitoring for any side effects or adverse events. Some specific safety measures include:

  • Regular monitoring of blood cell counts, kidney function, and liver function
  • Watching for any signs of heart problems
  • Monitoring for any unexpected side effects
Patients considering this treatment should discuss potential risks and benefits thoroughly with their healthcare provider[1].

Aspect Details
Drug Name Actinium (Ac 225) Oxodotreotide (RYZ101)
Trial Phase Phase 1b/3
Target Condition Advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
Patient Population Patients with inoperable, advanced, SSTR+ GEP-NETs that progressed after 177Lu-SSA therapy
Primary Objectives Determine recommended dose, assess safety and tolerability, compare PFS to standard of care
Secondary Objectives Evaluate overall survival, objective response rate, and quality of life measures
Administration Intravenous injection
Key Eligibility Criteria Adequate organ function, no recent major surgeries or radiation therapy, no brain metastases
Safety Monitoring Adverse events, laboratory changes, ECG changes

FAQ

  • What is Actinium (Ac 225) Oxodotreotide, and how is it being used in clinical trials? Actinium (Ac 225) Oxodotreotide, also called RYZ101, is an investigational drug being studied in clinical trials for patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). It is being compared to standard of care therapies in patients whose tumors have progressed after previous treatment with certain radioactive drugs.
  • Who is eligible to participate in this clinical trial? Eligible participants include patients with inoperable, advanced GEP-NETs that express somatostatin receptors (SSTR+) and have progressed after previous treatment with Lu-177 labeled somatostatin analogue therapy. Patients must meet specific criteria regarding organ function, previous treatments, and other health conditions.
  • What are the main objectives of this clinical trial? The main objectives are to determine the recommended dose of RYZ101, assess its safety and tolerability, and compare its effectiveness to standard of care therapy in improving progression-free survival in patients with GEP-NETs.
  • How is the drug administered in this trial? RYZ101 is administered through intravenous (IV) injection. The trial will determine the appropriate dose and schedule for administration.
  • What are some of the potential benefits and risks of participating in this trial? Potential benefits include access to a new investigational treatment and close monitoring by healthcare professionals. Risks may include side effects from the drug and the possibility that it may not be more effective than standard treatments. The trial will closely monitor patients for any adverse events and assess the drug's effectiveness compared to current therapies.

Ongoing Clinical Trials on Actinium (Ac 225) Oxodotreotide

  • Study on RYZ101 for Patients with Advanced Gastroenteropancreatic Neuroendocrine Tumors After Previous Treatment

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France The Netherlands Spain

Glossary

  • Gastroenteropancreatic neuroendocrine tumors (GEP-NETs): A type of cancer that forms in the hormone-producing cells of the digestive system and pancreas.
  • Somatostatin receptor expressing (SSTR+): Tumors that have specific receptors on their surface which can bind to somatostatin or similar molecules, making them potential targets for certain treatments.
  • 177Lu-labelled somatostatin analogue (177Lu-SSA) therapy: A type of targeted radiation therapy using a radioactive form of lutetium attached to a molecule similar to somatostatin, which can bind to certain tumor cells.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives without the cancer progressing or getting worse.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.
  • Adverse events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Quality of life (QoL): A measure of an individual's well-being and ability to carry out daily activities, often assessed in cancer trials using specific questionnaires.

References

  1. http://clinicaltrials.eu/trial/study-on-ryz101-for-patients-with-advanced-gastroenteropancreatic-neuroendocrine-tumors-after-previous-treatment/