RYZ101 for Neuroendocrine Tumors
(ACTION-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called RYZ101 (also known as 225Ac-DOTATATE) for individuals with advanced neuroendocrine tumors that cannot be surgically removed. The trial aims to determine if RYZ101 is safe and effective compared to standard treatments for tumors that have continued to grow despite previous therapy. Suitable candidates have tumors related to the stomach or pancreas that have worsened even after specific radiation therapy. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants access to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on high-dose glucocorticoids (a type of steroid), you must stop them 14 days before starting the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that RYZ101 was well-tolerated in earlier studies. One study found that a dose of 10.2 MBq of RYZ101 was safe for further testing, with no major side effects reported at this dose. This finding is encouraging for those considering participation in a trial with RYZ101, as it suggests the treatment is safe for more testing in future trials. However, long-term safety information is still being collected, and more details will become available as additional studies are completed.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about RYZ101 for neuroendocrine tumors because it employs a novel approach using a radiolabeled somatostatin analog (SSA). Unlike standard treatments like everolimus, sunitinib, octreotide, or lanreotide, RYZ101 is linked with Actinium-225, which delivers targeted radiation directly to the tumor cells. This targeted approach could potentially minimize damage to surrounding healthy tissues while effectively attacking the tumor, offering a promising new avenue for treatment.
What evidence suggests that RYZ101 might be an effective treatment for neuroendocrine tumors?
Research has shown that RYZ101, which participants in this trial may receive, may help treat neuroendocrine tumors. Early lab studies demonstrated that RYZ101 slowed tumor growth, particularly in tumors with more somatostatin receptors. Initial human studies found that some patients' cancer did not worsen. Research on a similar treatment, 225Ac-DOTATATE, showed that it helped patients with neuroendocrine tumors live longer. These findings suggest that RYZ101 could be effective for patients whose tumors have continued to grow after other treatments.678910
Who Is on the Research Team?
Ye Yuan, MD
Principal Investigator
RayzeBio Sr. Medical Director
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1b Treatment
Uncontrolled dose de-escalation study to confirm the safety and determine the RP3D of RYZ101
Phase 3 Treatment
Comparison of RYZ101 with investigator-selected standard of care therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RYZ101
Find a Clinic Near You
Who Is Running the Clinical Trial?
RayzeBio, Inc.
Lead Sponsor