RayzeBio is sponsoring the phase 1/3 ACTION-1 study for patients who have inoperable, progressive, somatostatin receptor positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NET). 

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The trial is a part of larger international study and will compare the standard of care therapy with 225Ac-DOTATATE (RYZ101). The phase 1 portion of the study will look at the safety and tolerability of RYZ101.

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The phase 1 of the study is currently enrolling at sites across the country.

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Main Eligibility Criteria:

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• Over 18 years of age

• Grade 1-2 well differentiated GEP-NET (GI or pancreas)

• Ki67 <= 20%

• Progressive GEP-NET following 2 to 4 cycles of treatment with 177Lu-DOTATATE / 177Lu-DOTATOC. If 177Lu-DOTATATE or 177Lu-DOTATOC treatment was stopped before completing 4 cycles, it should not have been stopped early due to disease progression.

• Must have had some response to PRRT, defined as tumor shrinkage or tumor stability, that lasted at least 3 months following the last dose of prior 177Lu-DOTATATE/DOTATOC

• No prior treatment with alkylating agents

• No prior use of anticancer agents within the following intervals prior to the first dose of study drug:

  • Peptide Receptor Radionuclide Therapy (PRRT): within <8 weeks

  • Chemotherapy: within <6 weeks

  • Small molecule inhibitors: within <4 weeks

  • Biological agents: within <7 days or <5 half-lives

• No prior external radiation therapy, including stereotactic body radiation therapy (SBRT)

• No prior radioembolization treatment

• No significant cardiovascular disease

• No known brain metastases

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If you are interested in learning more, please ask your doctor to contact clinicaltrials@rayzebio.com.