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Purpose

The primary objectives are to determine the recommended Phase 2 dose (RP2D) and optimal treatment regimen, characterize safety and tolerability, and evaluate preliminary efficacy of RYZ401 in subjects with NETs and other selected solid tumors expressing SSTRs.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • At least 18 years old at the time of signing the main study informed consent form (ICF). - Histologically confirmed: Dose Escalation (all cohorts): Grades 1-3 WD, metastatic or locally advanced and unresectable NET at any primary site, including, but not limited to, GI, pancreatic, lung, thyroid, breast, urogenital, and adrenal tumors. - Dose Expansion Cohort A: Grades 1-3 WD, metastatic or locally advanced and unresectable GEP-NETs - Dose Expansion Cohort B: metastatic or locally advanced and unresectable tumors known to frequently express SSTR, limited to the following indications: - WD NETs (Grades 1-3) from primary sites other than gastrointestinal and pancreatic (including, but not limited to, lung, thyroid, breast, urogenital, and adrenal tumors) Meningioma (Grades 1-3) - SSTR-positive disease, as assessed by SSTR-PET imaging - Adequate renal, hematologic and hepatic function

Exclusion Criteria

  • Prior RPT, including Lu-177. - Prior solid organ or bone marrow transplantation. - Use of chronic systemic steroid therapy. - Significant cardiovascular disease - Resistant hypertension - Uncontrolled diabetes - Prior history of liver cirrhosis - HIV, hepatitis B infection or known active hepatitis C virus infection. Note: Additional criteria may apply and will be assessed by the study site

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation, Dose Expansion
  • Drug: RYZ401
    Ac-225

Recruiting Locations

Research Facility
Iowa City, Iowa 52242

Research Facility
Lexington, Kentucky 40536

Research Facility
St Louis, Missouri 63104

Research Facility
Salt Lake City, Utah 84112

More Details

Status
Recruiting
Sponsor
RayzeBio, Inc.

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.