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

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What is this study about?

This clinical trial is focused on studying a type of cancer known as gastroenteropancreatic neuroendocrine tumors (GEP-NETs). These tumors are found in the digestive system and pancreas and are characterized by their expression of a specific protein called somatostatin receptor. The study is investigating a new treatment called RYZ101, which is being compared to standard treatments for this condition. The standard treatments include medications such as Everolimus, Sunitinib, Octreotide, and Lanreotide. These medications are used when the tumors have progressed after previous therapy with a type of drug known as 177Lu-labelled somatostatin analogue (177Lu-SSA).

The purpose of the study is to determine if RYZ101 can improve the condition of patients compared to the standard treatments. The study is divided into two parts. In the first part, the focus is on finding the right dose of RYZ101 and assessing its safety and how well it is tolerated by patients. In the second part, the study aims to see if RYZ101 can help patients live longer without their disease getting worse, compared to those receiving standard treatments. The study involves taking the medication either by mouth, as in the case of Everolimus and Sunitinib, or through injections, as with Octreotide and Lanreotide.

Participants in the study will receive either RYZ101 or one of the standard treatments, and their progress will be monitored over time. The study will look at various outcomes, including how long patients live without their disease worsening and any side effects they may experience. This research is important for finding better ways to treat GEP-NETs and improving the quality of life for those affected by this condition.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient will be required to provide informed consent, acknowledging understanding of the trial and its potential risks and benefits.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes evaluating renal and hematologic function, as well as other health parameters. Women of childbearing potential will need a negative pregnancy test.

3 treatment allocation

The patient will be randomly assigned to receive either RYZ101 or a standard of care (SoC) therapy. The SoC options include everolimus 10 mg daily by mouth, sunitinib 37.5 mg daily by mouth, high-dose octreotide 60 mg every four weeks by intramuscular injection, or high-dose lanreotide 120 mg every two weeks by deep subcutaneous injection.

4 treatment administration

If assigned to RYZ101, the patient will receive the medication intravenously. The specific dosage and frequency will be determined based on the trial’s phase and the patient’s response.

If assigned to SoC therapy, the patient will follow the prescribed regimen for the selected medication.

5 monitoring and follow-up

The patient will be monitored regularly for any side effects or adverse events. This includes laboratory tests, ECGs, and other safety assessments.

Progression-free survival (PFS) and overall survival (OS) will be evaluated to determine the effectiveness of the treatment.

6 end of treatment

The treatment will continue until disease progression, unacceptable toxicity, or other criteria for discontinuation are met.

After the treatment ends, the patient will have a final assessment to evaluate the overall health status and any long-term effects of the treatment.

Who Can Join the Study?

The patient must have a type of cancer called gastro-enteropancreatic neuroendocrine tumors (GEP-NETs).
The patient should be a candidate for one of the following standard treatments:
- Everolimus 10 mg taken daily by mouth
- Sunitinib 37.5 mg taken daily by mouth
- High-dose octreotide LAR 60 mg given by intramuscular injection every 4 weeks
- High dose frequency lanreotide 120 mg given by deep subcutaneous injection every 2 weeks
The patient must have adequate kidney function, which means their kidneys are working well enough, as shown by a test result called eGFR of 60 or more.
The patient must have adequate blood function, which means their blood tests show:
- Hemoglobin (a part of red blood cells) of 8.0 g/dL or more
- ANC (a type of white blood cell) of 1000 cells/mm³ or more
- Platelets (cells that help with blood clotting) of more than 100,000 per mm³
The patient’s total bilirubin (a substance made by the liver) must be 3 times the normal limit or less.
The patient’s serum albumin (a protein in the blood) must be 3.0 g/dL or more, unless their prothrombin time (a blood clotting test) is normal.
For women who can have children:
- They must have a negative pregnancy test within 48 hours before starting the study treatment.
- They must agree to use two forms of effective birth control or practice total abstinence while receiving the study treatment and for 7 months after the last dose.
- A woman is considered able to have children if she has started menstruating, has not gone through menopause (12 months without a period), and has not had surgery to prevent pregnancy.
Sexually active male patients must use a condom during intercourse while receiving the study treatment and for 4 months after the last dose. They should not father a child during this time.
- If their partner can have children, they must also use a second form of effective birth control or practice total abstinence.
- Men who have had a vasectomy must still use a condom to prevent passing the drug through seminal fluid.

Who Cannot Join the Study?

Patients who have not been diagnosed with gastro-enteropancreatic neuroendocrine tumors (GEP-NETs). These are a type of tumor that can occur in the stomach, intestines, or pancreas.
Patients whose tumors do not have SSTR+. This means the tumors do not have a specific type of receptor that the study is targeting.
Patients who have not previously been treated with 177Lu-SSA. This is a type of therapy used for treating certain tumors.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or attend the required visits.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are part of a vulnerable population that the study cannot safely include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
University Hospital Maastricht	Maastricht	The Netherlands
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Netherlands Cancer Institute	Amsterdam	The Netherlands
Hopital Beaujon	Clichy	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Algemeen Ziekenhuis Delta	Roeselare	Belgium
MD Anderson Cancer Center	Madrid	Spain
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Centre Hospitalier Universitaire De Nantes	Nantes	France
Cnbddbclh Uzwdyjbzaedlvn Sdwdjuxpg	Woluwe-Saint-Lambert	Belgium
Ixugbjxc Repecziv Dj Cgpibs Dn Mbimuuujgis	Montpellier	France
Claa Dy Ngqva	Vandoeuvre Les Nancy	France
Fezgluynr Pxqf Li Iwcdhycosllgp Bfzwwjsol Dpd Hdbaxgym Unhgmcsrcoxvj Lo Pwb	Madrid	Spain
Hnjukjpb Vawz drkmhwak	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	10.08.2023
France	Not recruiting	10.08.2023
Spain	Recruiting	10.08.2023
The Netherlands	Recruiting	10.08.2023

Trial locations

Investigated drugs:

RYZ101 is an investigational medication being studied for its potential to treat advanced gastro-enteropancreatic neuroendocrine tumors (GEP-NETs) that express somatostatin receptors. These tumors have progressed despite previous treatment with a specific type of therapy known as 177Lu-labelled somatostatin analogue. The trial aims to determine the appropriate dosage and evaluate the safety and effectiveness of RYZ101 in managing these tumors.

Investigated diseases:

Gastroenteropancreatic neuroendocrine tumour disease

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) – These are a group of rare tumors that originate in the neuroendocrine cells of the gastrointestinal tract and pancreas. They can produce hormones that cause various symptoms, depending on the location and type of tumor. GEP-NETs can be classified as either functioning or non-functioning, based on whether they secrete hormones that lead to clinical symptoms. The progression of these tumors can vary, with some growing slowly over many years, while others may grow more rapidly. They often spread to other parts of the body, such as the liver, before being diagnosed. The behavior and growth rate of GEP-NETs can be unpredictable, making them challenging to manage.

Trial ID:

2023-509334-19-00

Protocol code:

RYZ101-301

NCT ID:

NCT05477576

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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