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Virus Therapy
RYZ101 for Neuroendocrine Tumors (ACTION-1 Trial)
Phase 3
Recruiting
Research Sponsored by RayzeBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate renal function (CrCl ≥60 mL/min)
Histologically proven, Grade 1-2 well differentiated, inoperable, advanced GEP-NETs (Ki67 ≤20%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 80 months or until a total of 130 deaths have occurred, whichever occurs first
Awards & highlights
ACTION-1 Trial Summary
This trial is testing a new drug, RYZ101, for safety and effectiveness in treating patients with a certain type of cancer that has spread and progressed after treatment with other drugs.
Who is the study for?
This trial is for adults with advanced, inoperable GEP-NETs that express somatostatin receptors and have progressed after treatment with 177Lu-SSA therapy. Participants must have a life expectancy of at least 12 weeks, stable symptoms controlled by SSAs, adequate kidney and blood function, and agree to use effective contraception.Check my eligibility
What is being tested?
The study tests RYZ101's safety and dosage compared to standard care therapies like Everolimus or Sunitinib in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). It has two parts: determining the safe dose of RYZ101 and comparing its effectiveness against other treatments.See study design
What are the potential side effects?
Potential side effects include typical reactions related to cancer medications such as nausea, fatigue, changes in blood counts leading to increased infection risk or bleeding tendencies. Specific side effects of RYZ101 are not detailed but may be similar to those observed with comparable therapies.
ACTION-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys are working well.
Select...
My tumor is a low to intermediate grade and cannot be removed by surgery.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
ACTION-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 80 months or until a total of 130 deaths have occurred, whichever occurs first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 80 months or until a total of 130 deaths have occurred, whichever occurs first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b: RP3D
Phase 3: PFS as determined by BICR
Secondary outcome measures
Phase 1b: AUC
Phase 1b: Absorbed radiation doses of RYZ101 to critical organs and tumors
Phase 1b: Clearance
+12 moreOther outcome measures
Electrocardiogram
Phase 3: AUC
Phase 3: Average Concentration
+7 moreACTION-1 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Phase 1b - RYZ101Experimental Treatment1 Intervention
Part 1 is an uncontrolled dose de-escalation study to confirm the safety and determine the RP3D of RYZ101 based on Bayesian optimal interval design. Eligible participants will be enrolled in cohorts of 6 to receive RYZ101 up to 4 infusions every 8 weeks. If the initial dose level is not tolerated, the dose will be de-escalated; up to 3 dose levels will be assessed.
Group II: Phase 3 - Standard of CareActive Control4 Interventions
Investigator's choice of standard of care between everolimus, sunitinib, octreotide, or lanreotide.
Group III: Phase 3 - RYZ101Active Control1 Intervention
Actinium 225 radiolabeled somatostatin analog (SSA) for injection
Find a Location
Who is running the clinical trial?
RayzeBio, Inc.Lead Sponsor
2 Previous Clinical Trials
61 Total Patients Enrolled
Denis Ferreira, MDStudy DirectorRayzeBio Sr. Medical Director
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken high-dose steroids for my condition in the last 14 days.My tumor is a low to intermediate grade and cannot be removed by surgery.I am a man who will use protection and avoid fathering a child while on the study drug and for 3 months after.My kidneys are working well.I am on a stable dose of medication for symptom control of my functional tumor.I haven't had cancer, except for specific types, in the last 3 years.I do not have serious heart disease, uncontrollable high blood pressure, or diabetes.My blood counts are within a healthy range.I have had radiation therapy recently.I can take care of myself and am up and about more than 50% of my waking hours.I have received PRRT treatment, but not with Lu-177 SSA.Your bilirubin levels are not more than three times the normal upper limit.Your blood protein level (serum albumin) is above 3.0 g/dL, unless your prothrombin time is normal.I have a history of liver cirrhosis.I do not have any mental or physical health conditions that could affect the study.You are expected to live for at least 12 more weeks.My NET has grown despite 2-4 treatments with Lu-177 and was stable for 6+ months after.I haven't taken any cancer drugs recently.I haven't had treatments like chemo, surgery, or radiation in the last 3 months.I am allergic to specific imaging agents or their components.I have brain or spinal cord metastases but meet specific conditions for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b - RYZ101
- Group 2: Phase 3 - Standard of Care
- Group 3: Phase 3 - RYZ101
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current vacancies for participants in this research?
"The trial, which clinicaltrials.gov has listed as actively recruiting patients, was first posted on 3/24/2022 and edited most recently on 10/11/2022."
Answered by AI
Who else is applying?
What site did they apply to?
Dana-Farber Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
Sutent don't work for me.
PatientReceived 2+ prior treatments
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