Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (ACTION-1)

April 8, 2024 updated by: RayzeBio, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

288

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Brussel, Belgium
        • Recruiting
        • Cliniques universitaires Saint-Luc
        • Principal Investigator:
          • Ivan BORBATH, MD
        • Contact:
      • Brussels, Belgium
      • Leuven, Belgium
        • Not yet recruiting
        • UZ Leuven
        • Principal Investigator:
          • Christophe Deroose, MD
        • Contact:
        • Contact:
          • Phone Number: +32 16 34 86 78
      • Roeselare, Belgium
        • Recruiting
        • AZ Delta
        • Contact:
        • Principal Investigator:
          • Kristoff Muylle, MD
  • Brazil
      • Brasília, Brazil
        • Recruiting
        • Sociedade Beneficente De Senhoras Hospital - Sírio-Libanês Brasilia
        • Contact:
        • Principal Investigator:
          • Brenda Pires Gumz, MD
      • Rio De Janeiro, Brazil
        • Not yet recruiting
        • Instituto D'Or de Pesquisa e Ensino
        • Contact:
        • Principal Investigator:
          • Paulo Henrique Rosado de Castro, MD
      • Rio De Janeiro, Brazil
        • Not yet recruiting
        • Instituto Nacional de Cancer
        • Contact:
        • Principal Investigator:
          • Daniel Bulzico, MD
      • São Paulo, Brazil
        • Not yet recruiting
        • Hospital Israelita Albert Einstein
        • Contact:
        • Principal Investigator:
          • Diogo Bugano Diniz Gomes, MD
      • São Paulo, Brazil
        • Not yet recruiting
        • Fundacao Antonio Prudente - A.C. Camargo Cancer Center
        • Contact:
        • Principal Investigator:
          • Rachel Riechelmann, MD
      • São Paulo, Brazil
        • Recruiting
        • Sociedade Beneficente de Senhoras Hospital Sirio-Libanes
        • Contact:
        • Principal Investigator:
          • Carlos Alberto Buchpiguel, MD
  • Canada
      • Toronto, Canada
        • Not yet recruiting
        • University Health Network - Princess Margaret Cancer Centre
        • Contact:
        • Principal Investigator:
          • Rebecca Wong, MD
    • Ontario
      • London, Ontario, Canada
        • Recruiting
        • London Health Sciences Centre
        • Contact:
          • David Laidley, MD
        • Principal Investigator:
          • David Laidley, MD
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Sten Myrehaug, MD
    • Quebec
      • Montréal, Quebec, Canada
        • Recruiting
        • Jewish General Hospital
        • Principal Investigator:
          • Petr Kavan, MD
        • Contact:
          • Petr Kavan
        • Contact:
  • France
      • Clichy, France
        • Not yet recruiting
        • CHU Beaujon, APHP.Nord - Université Paris Cité
        • Contact:
        • Principal Investigator:
          • Louis de Mestier
      • Lille, France
        • Not yet recruiting
        • CHRU de Lile
        • Contact:
        • Principal Investigator:
          • Amandine Beron
      • Nantes, France
        • Recruiting
        • CHU de Nantes
        • Principal Investigator:
          • Catherine Ansquer
        • Contact:
      • Vandoeuvre-Lès-Nancy, France
        • Not yet recruiting
        • CHRU de Nancy Hôpital de Brabois
        • Contact:
        • Principal Investigator:
          • Elodie Chevalier
      • Villejuif, France
        • Not yet recruiting
        • Institut Gustave Roussy
        • Principal Investigator:
          • Eric Baudin, MD
        • Contact:
  • Netherlands
      • Utrecht, Netherlands
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Jaume Capdevila, MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
        • Principal Investigator:
          • Rocio Garcia-Carbonero, MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario La Paz
        • Contact:
        • Principal Investigator:
          • Ana Custodio Carretero, MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
        • Principal Investigator:
          • Teresa Alonso Gordoa, MD
      • Madrid, Spain
        • Not yet recruiting
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Enrique Grande, MD
        • Contact:
      • Madrid, Spain
        • Not yet recruiting
        • Hospital HM Universitario Sanchinarro
        • Contact:
        • Principal Investigator:
          • Antonio Cubillo Gracian, MD
      • Zaragoza, Spain
        • Not yet recruiting
        • Hospital Universitario Miguel Servet
        • Contact:
        • Principal Investigator:
          • Vicente Alonso, MD
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Arizona
        • Contact:
          • Clinical Trials Referral Office
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Mohamed (Bassam) Sonbol, MD
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
        • Contact:
          • Daneng Li, MD
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Nuclear Medicine
        • Contact:
        • Principal Investigator:
          • Martin Allen-Auerbach, MD
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Memorial Hospital Presbyterian
        • Contact:
        • Principal Investigator:
          • Gary Ulaner, MD, PhD
      • Palo Alto, California, United States, 94305
        • Not yet recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Carina Mari Aparici, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Principal Investigator:
          • Courtney Lawhn Heath, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale Cancer Center
        • Contact:
        • Principal Investigator:
          • Pamela Kunz, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Principal Investigator:
          • Anteneh Tesfaye, MD
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Florida
        • Contact:
          • Clinical Trials Referral Ofice
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Jason Starr, DO
      • Miami, Florida, United States, 33165
        • Recruiting
        • Biogenix Molecular
        • Principal Investigator:
          • Frankis Almaguel, MD
        • Contact:
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Jonathan Strosberg, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute, Emory University Hospital Midtown
        • Contact:
        • Principal Investigator:
          • Amol Takalkar, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals & Clinics
        • Principal Investigator:
          • David Bushnell, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky Markey Cancer Center
        • Contact:
        • Contact:
          • Phone Number: (859) 323-7628
        • Principal Investigator:
          • Anthony Lowell, MD
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Recruiting
        • Advanced Molecular Imaging and Therapy
        • Contact:
          • Michael Morris, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Heather Jacene, MD
        • Contact:
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hussein Assi, MD
    • Michigan
      • Troy, Michigan, United States, 48098
        • Recruiting
        • Profound Research LLC/MHP Radiation Oncology Institute
        • Contact:
        • Principal Investigator:
          • Thomas P. Boike, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Contact:
          • Clinical Trials Referral Office
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Thorvardur (Thor) Halfdanarson, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University - St. Louis
        • Principal Investigator:
          • Richard Wahl, MD
        • Contact:
    • Nebraska
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
        • Principal Investigator:
          • Edward Wolin, MD
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering
        • Principal Investigator:
          • Lisa Bodei, MD
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Principal Investigator:
          • Amr Mohamed, MD
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Principal Investigator:
          • Erik Mittra, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center
        • Contact:
        • Principal Investigator:
          • Kenneth G Bennet, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Clinical Trials Information Program
          • Phone Number: 800-811-8480
          • Email: cip@vumc.org
        • Principal Investigator:
          • Robert Ramirez, DO
    • Texas
      • Houston, Texas, United States, 77030
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Hospital University of Utah
        • Contact:
          • Heloisa P Soares, MD, PhD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Principal Investigator:
          • Amir Iravani, MD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Subjects must meet all the following criteria for enrollment in the study:

  1. Histologically proven, Grade 1-2 well differentiated, inoperable, advanced GEP-NETs (Ki67 ≤20%)
  2. Eastern Cooperative Oncology Group (ECOG) status 0-2
  3. Life expectancy of at least 12 weeks

  4. Subjects with functional tumors who are receiving SSAs on a stable dose for symptom control .

    Subjects that do not require octreotide LAR or lanreotide for symptom control must discontinue SSAs at least 4 weeks prior to randomization.

  5. Progressive, SSTR-PET positive (i.e., Krenning score 3 or 4) GEP-NET (GI or pancreas) based on RECIST v1.1 following 2-4 cycles of treatment with 177Lu-labeled SSA. Must have achieved disease control for at least 6 months following Lu-177 SSA. Radiographic progression must be demonstrated within 18 months of randomization. No time limit is defined between 177Lu-SSA treatment and randomization. Premature discontinuation of Lu-177 SSA treatment should not have been due to PD.

  6. Part 2: Subject is a candidate for therapy with 1 of the following SoC options:

    1. Everolimus 10 mg daily
    2. Sunitinib 37.5 mg daily
    3. High-dose octreotide LAR 60 mg Q4W
    4. High dose frequency lanreotide 120 mg every 2 weeks (Q2W)
  7. Adequate renal function, as evidenced by creatinine clearance (CrCl) ≥60 mL/min (calculated using the Cockcroft-Gault formula) (Cockcroft and Gault, 1976)

  8. Adequate hematologic function, defined by the following laboratory results:

    1. Part 1: Hemoglobin concentration ≥5.6 mmol/L (≥9.0 g/dL); absolute neutrophil count (ANC) ≥1500 cells/µL (≥1500 cells/mm3); platelets ≥100 x 109/L (100 x 103/mm3)
    2. Part 2: Hemoglobin concentration ≥5.0 mmol/L (≥8.0 g/dL); ANC ≥1000 cells/µL (≥1000 cells/mm3); platelets ≥75 x 109/L (75 x 103/mm3).
  9. Total bilirubin ≤3 x upper limit normal (ULN)
  10. Serum albumin ≥3.0 g/dL unless prothrombin time is within the normal range
  11. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 48 hours prior to the first dose of study drug and agree to use barrier contraception and a second form of highly effective contraception (Clinical Trials Facilitation Group [CTFG] 2014) or total abstinence while receiving study drug and for 6 months following their last dose of RYZ101.
  12. Sexually active male subjects must use a condom during intercourse while receiving study drug and for 3 months after the last dose of the study drug and should not father a child during this period. If sexual partners are WOCBP must also agree to use a second form of highly effective contraception (CTFG 2014) or total abstinence while receiving study drug and for 3 months following their last dose of RYZ101.
  13. Able to read and/or understand the details of the study and provide written informed consent prior to any study-specific assessments and procedures commence

Subjects who meet any of the following criteria will be excluded from the study:

  1. Known hypersensitivity to 225Actinium, 68Gallium, 64Copper, octreotate, or any of the excipients of DOTATATE imaging agents
  2. Part 1: Prior treatment with alkylating agents
  3. Prior radioembolization
  4. Any surgery, chemoembolization, and radiofrequency ablation within 12 weeks prior to first dose of study drug

  5. Use of anticancer agents within the following intervals prior to the first dose of study drug:

    1. PRRT: within <6 months
    2. Chemotherapy: within <6 weeks
    3. Small molecule inhibitors: within <4 weeks
    4. Biological agents: within 4 weeks

  6. Prior external-beam radiation (EBRT) therapy as defined below:

    1. Part 1: Any prior EBRT, including SBRT
    2. Part 2: Prior EBRT within 6 weeks prior to study enrollment or any prior EBRT to more than 25% of the bone marrow
  7. Prior participation in any interventional clinical study within 30 days prior to first dose of study drug
  8. Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
  9. Significant cardiovascular disease, such as New York Heart Association (NYHA) Class ≥II heart failure, left ventricular ejection fraction (LVEF) <40% or QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms for males and >470 ms for females.
  10. Resistant hypertension, defined as uncontrolled blood pressure (BP) >140/90 mmHg while on optimal doses of at least 3 antihypertensive medications with 1 being a diuretic (Whelton et al. 2018)
  11. Uncontrolled diabetes mellitus as defined by hemoglobin A1C (HgB A1C) ≥8%
  12. Have a history of primary malignancy within the past 3 years other than (1) GEP-NET, (2) adequately treated carcinoma in situ or non-melanoma carcinoma of the skin, (3) any other curatively treated malignancy that is not expected to require treatment for recurrence during participation in the study, or (4) an untreated cancer on active surveillance that may not affect the subject's survival status for ≥3 years based on clinician assessment/statement and with Medical Monitor approval.
  13. Known brain, meningeal or spinal cord metastases. In Part 2, subjects with previously treated brain metastases will be allowed if the following conditions are met: (a) there is no evidence of central nervous system (CNS) progression for at least 6 months as assessed by local MRI for brain metastasis during screening; (b) the subject has recovered from acute side effects of radiotherapy; and (c) the subject is receiving a stable or decreasing dose of steroids.
  14. Subject requires other treatment that in the opinion of the investigator would be more appropriate than the therapy offered in the study
  15. Pregnancy or lactation
  16. Unable or unwilling to comply with the requirements of the study protocol
  17. PRRT other than Lu-177 SSA
  18. 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.
  19. Prior history of liver cirrhosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1b - RYZ101
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.
Drug: RYZ101
RP3D as determined in Phase 1b
Active Comparator: Phase 3 - RYZ101
Actinium 225 radiolabeled somatostatin analog (SSA) for injection
Drug: RYZ101
RP3D as determined in Phase 1b
Active Comparator: Phase 3 - Standard of Care
Investigator's choice of standard of care between everolimus, sunitinib, octreotide, or lanreotide.
Drug: Everolimus 10 mg
Everolimus 10 mg daily by mouth
Drug: Sunitinib 37.5 MG
Sunitinib 37.5 mg daily by mouth
Drug: Octreotide LAR 60 MG Injection
High-dose octreotide LAR 60 mg Q4W by i.m. injection
Drug: Lanreotide 120Mg Sa Susp Inj Syringe
High dose frequency lanreotide 120 mg Q2W by deep s.c. injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1b: RP3D
Time Frame: 56 days of study treatment
Incidence of DLTs during the first 56 days of study treatment will be assessed.
56 days of study treatment
Phase 3: PFS as determined by BICR
Time Frame: After the target number of 143 PFS events have occurred
PFS will be defined as the time from the date of randomization until the date of progression (as determined by BICR from tumor assessments using RECIST v1.1) or death due to any cause, whichever occurs earlier.
After the target number of 143 PFS events have occurred

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1b: Cmax
Time Frame: Up to Day 8
Up to Day 8
Phase 1b: Tmax
Time Frame: Up to Day 8
Up to Day 8
Phase 1b: AUC
Time Frame: Up to Day 8
Up to Day 8
Phase 1b: Volume of Distribution
Time Frame: Up to Day 8
Up to Day 8
Phase 1b: Clearance
Time Frame: Up to Day 8
Up to Day 8
Phase 1b: Terminal Half-life
Time Frame: Up to Day 8
Up to Day 8
Phase 1b: TIAC of RYZ101 to critical organs and tumors
Time Frame: Up to Day 184
Calculated mean TIAC (hours) and absorbed radiation dose coefficients (mGy/MBq) to critical organs (e.g., the kidneys and bone marrow) and tumors after the 1st and 4th RYZ101 infusions will be assessed
Up to Day 184
Phase 1b: Absorbed radiation doses of RYZ101 to critical organs and tumors
Time Frame: Up to Day 184
Calculated mean TIAC (hours) and absorbed radiation dose coefficients (mGy/MBq) to critical organs (e.g., the kidneys and bone marrow) and tumors after the 1st and 4th RYZ101 infusions will be assessed
Up to Day 184
Phase 3: OS
Time Frame: Up to 80 months or until a total of 130 deaths have occurred, whichever occurs first
OS will be defined as the time from the date of randomization until the date of death due to any cause.
Up to 80 months or until a total of 130 deaths have occurred, whichever occurs first
Phase 3: ORR by BICR
Time Frame: Up to 80 months
ORR, as determined by BICR according to RECIST v1.1.
Up to 80 months
Phase 3: PFS
Time Frame: Up to 80 months
PFS as determined by Investigator
Up to 80 months
Phase 3: ORR by Inv
Time Frame: Up to 80 months
ORR, as assessed by the Investigator according to RECIST v1.1
Up to 80 months
Phase 3: BOR
Time Frame: Up to 80 months
Assessed by BICR and by the Investigator according to RECIST v1.1
Up to 80 months
Phase 3: Disease Control Rate
Time Frame: Up to 80 months
Assessed by BICR and by the Investigator according to RECIST v1.1
Up to 80 months
Phase 3: DoR
Time Frame: Up to 80 months
Only for subjects with a RECIST v.1.1 response, assessed by BICR and by the Investigator according to RECIST v1.1
Up to 80 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1b and 3: Incidence and severity of AEs by NCI CTCAE v5, including SAEs, laboratory changes, ECG changes, and other safety findings
Time Frame: Up to 80 months
Incidence and severity of AEs by NCI CTCAE v5, including SAEs, laboratory changes, ECG changes, and other safety findings
Up to 80 months
Phase 3: Cmax
Time Frame: Up to 80 months
Up to 80 months
Phase 3: AUC
Time Frame: Up to 80 months
Up to 80 months
Phase 3: Average Concentration
Time Frame: Up to 80 months
Up to 80 months
Phase 3: Relationship between exposure endpoints and clinical outcomes
Time Frame: Up to 80 months
Up to 80 months
Phase 3: Relationship between biomarkers including but not limited to CgA in the serum and (5-HIAA) in the urine, with AEs of special interest and/or efficacy endpoints (e.g., PFS, OS, BOR, DoR)
Time Frame: Up to 80 months
Relationship between biomarkers, including but not limited to CgA in the serum and (5-HIAA) in the urine, with AEs of special interest and/or efficacy endpoints (e.g., PFS, OS, BOR, DoR)
Up to 80 months
Phase 3: Changes in EQ-5D-5L questionnaire scores
Time Frame: Up to 80 months
Up to 80 months
Phase 3: Changes in EORTC QLQ-C30 questionnaire scores
Time Frame: Up to 80 months
Up to 80 months
Phase 3: Changes in EORTC QLQ GI NET21 questionnaire scores
Time Frame: Up to 80 months
Up to 80 months
Phase 3: QTc
Time Frame: Up to 80 months
Measured by continuous ECG recording using a 12-lead Holter monitoring device
Up to 80 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RayzeBio, Inc.

Investigators

  • Study Director: Denis Ferreira, MD, 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 Major Dates

Study Start (Actual)

March 24, 2022

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

July 20, 2022

First Submitted That Met QC Criteria

July 25, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RYZ101-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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