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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
RayzeBio, Inc.
Study ID
NCT05477576
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RYZ101 — DRUG
    RP3D as determined in Phase 1b
  • Everolimus — DRUG
    Everolimus
  • Sunitinib — DRUG
    Sunitinib
  • Octreotide — DRUG
    High-dose octreotide
  • Lanreotide — DRUG
    Lanreotide

Study Details

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.

Key Dates

Start date
Mar 24, 2022
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2030

Study Design

Enrollment
338 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: Phase 3 - RYZ101
    Actinium 225 radiolabeled somatostatin analog (SSA) for injection
  • Active Comparator: Phase 3 - Standard of Care
    Investigator's choice of standard of care between everolimus, sunitinib, octreotide, or lanreotide.
  • Active Comparator: Phase 3 - RYZ101, PK/ECG Substudy adhoc subcohort
    Actinium 225 radiolabeled somatostatin analog (SSA) for injection

Primary Outcome Measure

Phase 1b: RP3D [ Time Frame: 56 days of study treatment ]

Central Contacts

Locations (32)

FacilityCityStateZIPSite coordinators
Research FacilityPhoenixArizona85054-
Research FacilityDuarteCalifornia91010-
Research FacilityIrvineCalifornia92663
Site Contact
Research FacilityLos AngelesCalifornia90095-
Research FacilityPalo AltoCalifornia94305-
Research FacilitySan FranciscoCalifornia94143-
Research FacilityNew HavenConnecticut06510-
Research FacilityWashington D.C.District of Columbia20010-
Research FacilityJacksonvilleFlorida32224-
Research FacilityMiamiFlorida33165
Site Contact
Research FacilityTampaFlorida33607
Site Contact
Research FacilityAtlantaGeorgia30322-
Research FacilityIowa CityIowa52242
Site Contact
Research FacilityLexingtonKentucky40536
Site Contact
Research FacilityGlen BurnieMaryland21061
Site Contact
Research FacilityBostonMassachusetts02118-
Research FacilityBostonMassachusetts02215-
Research FacilityTroyMichigan48098-
Research FacilityRochesterMinnesota55905-
Research FacilitySt LouisMissouri63110
Site Contact
Research FacilityOmahaNebraska68130
Site Contact
Research FacilityNew YorkNew York10029-
Research FacilityNew YorkNew York10065
Site Contact
Research FacilityClevelandOhio44106-
Research FacilityColumbusOhio43221
Site Contact
Research FacilityPortlandOregon97239-
Research FacilityPhiladelphiaPennsylvania19104-
Research FacilityPittsburghPennsylvania15232
Site Contact
Research FacilityNashvilleTennessee37232-
Research FacilityHoustonTexas77030-
Research FacilitySalt Lake CityUtah84112
Site Contact
Research FacilitySeattleWashington98109
Site Contact

Find similar trials in Phoenix, AZ

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
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