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Virus Therapy

RYZ101 for Neuroendocrine Tumors (ACTION-1 Trial)

Phase 3
Waitlist Available
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%)
Must not have
Any condition requiring systemic treatment with high-dose glucocorticoids within 14 days prior to first dose of study treatment and/or which cannot be stopped while on study. Inhaled or topical steroids are permitted
Significant cardiovascular disease, resistant hypertension, uncontrolled diabetes mellitus
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

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidneys are working well.
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My tumor is a low to intermediate grade and cannot be removed by surgery.
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I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken high-dose steroids for my condition in the last 14 days.
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I do not have serious heart disease, uncontrollable high blood pressure, or diabetes.
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I have received PRRT treatment, but not with Lu-177 SSA.
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I have a history of liver cirrhosis.
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I am allergic to specific imaging agents or their components.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 80 months or until a total of 130 deaths have occurred, whichever occurs first
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 80 months or until a total of 130 deaths have occurred, whichever occurs first for reporting.

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 more
Other outcome measures
Electrocardiogram
Phase 3: AUC
Phase 3: Average Concentration
+7 more

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Targeted radioligand therapy, such as Lutetium-177 DOTATATE, works by binding to somatostatin receptors on the surface of neuroendocrine tumor cells. Once bound, the radioligand delivers localized radiation to the tumor cells, causing DNA damage and cell death while sparing surrounding healthy tissue. This targeted approach is crucial for NET patients as it offers a more precise treatment option with potentially fewer side effects compared to traditional chemotherapy. Other common treatments include somatostatin analogs, which inhibit hormone secretion and tumor growth, and molecularly targeted therapies like everolimus, which disrupts cancer cell proliferation by inhibiting the mTOR pathway. These therapies are important as they provide multiple avenues to control tumor growth and manage symptoms, improving the quality of life for NET patients.

Find a Location

Who is running the clinical trial?

RayzeBio, Inc.Lead Sponsor
3 Previous Clinical Trials
91 Total Patients Enrolled
Denis Ferreira, MDStudy DirectorRayzeBio Sr. Medical Director

Media Library

RYZ101 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05477576 — Phase 3
Neuroendocrine Tumor Disease Research Study Groups: Phase 1b - RYZ101, Phase 3 - Standard of Care, Phase 3 - RYZ101
Neuroendocrine Tumor Disease Clinical Trial 2023: RYZ101 Highlights & Side Effects. Trial Name: NCT05477576 — Phase 3
RYZ101 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05477576 — Phase 3
~81 spots leftby Jul 2025