RECRUITING

Study of RYZ101 Compared with SOC in Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity \[HA\]-DOTATATE.

Official Title

Phase 1b/3 Global, Randomized, Controlled, Open-label Trial Comparing Treatment with RYZ101 to Standard of Care Therapy in Subjects with Inoperable, Advanced, SSTR+, Well-differentiated GEP-NETs That Have Progressed Following Prior 177Lu-SSA Therapy

Quick Facts

Study Start:2022-03-24
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05477576

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

RayzeBio Clinical Trials
CONTACT
+1 619 657 0057
clinicaltrials@rayzebio.com

Principal Investigator

Denis Ferreira, MD
STUDY_DIRECTOR
RayzeBio Sr. Medical Director

Study Locations (Sites)

Research Facility
Phoenix, Arizona, 85054
United States
Research Facility
Duarte, California, 91010
United States
Research Facility
Irvine, California, 92663
United States
Research Facility
Los Angeles, California, 90095
United States
Research Facility
Palo Alto, California, 94305
United States
Research Facility
San Francisco, California, 94143
United States
Research Facility
New Haven, Connecticut, 06510
United States
Research Facility
Washington, District of Columbia, 20010
United States
Research Facility
Jacksonville, Florida, 32224
United States
Research Facility
Miami, Florida, 33165
United States
Research Facility
Tampa, Florida, 33607
United States
Research Facility
Atlanta, Georgia, 30322
United States
Research Facility
Iowa City, Iowa, 52242
United States
Research Facility
Lexington, Kentucky, 40536
United States
Research Facility
Glen Burnie, Maryland, 21061
United States
Research Facility
Boston, Massachusetts, 02118
United States
Research Facility
Boston, Massachusetts, 02215
United States
Research Facility
Troy, Michigan, 48098
United States
Research Facility
Rochester, Minnesota, 55905
United States
Research Facility
St. Louis, Missouri, 63110
United States
Research Facility
Omaha, Nebraska, 68130
United States
Research Facility
New York, New York, 10029
United States
Research Facility
New York, New York, 10065
United States
Research Facility
Cleveland, Ohio, 44106
United States
Research Facility
Portland, Oregon, 97239
United States
Research Facility
Philadelphia, Pennsylvania, 19104
United States
Research Facility
Pittsburgh, Pennsylvania, 15232
United States
Research Facility
Nashville, Tennessee, 37232
United States
Research Facility
Houston, Texas, 77030
United States
Research Facility
Salt Lake City, Utah, 84112
United States
Research Facility
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: RayzeBio, Inc.

  • Denis Ferreira, MD, STUDY_DIRECTOR, RayzeBio Sr. Medical Director

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-24
Study Completion Date2028-07

Study Record Updates

Study Start Date2022-03-24
Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

  • Neuroendocrine Tumors
  • SSTR+
  • GEP-NET
  • targeted radiotherapy
  • Gastroenteropancreatic Neuroendocrine Tumor
  • RayzeBio
  • Actinium
  • Ac 225
  • Dotatate
  • Everolimus
  • sunitinib
  • octreotide
  • lanreotide
  • PRRT
  • alpha emitter

Additional Relevant MeSH Terms

  • GEP-NET
  • Gastroenteropancreatic Neuroendocrine Tumor
  • Gastroenteropancreatic Neuroendocrine Tumor Disease
  • Neuroendocrine Tumors
  • Carcinoid
  • Carcinoid Tumor
  • Pancreatic NET