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

Phase 3

Recruiting

• Conditions: GEP-NET; Pancreatic NET; Gastroenteropancreatic Neuroendocrine Tumor; Gastroenteropancreatic Neuroendocrine Tumor Disease; Neuroendocrine Tumors; Carcinoid Tumor; Carcinoid
• Interventions: Drug: RYZ101; Drug: Everolimus; Drug: Sunitinib; Drug: Octreotide; Drug: Lanreotide

• Registration Number: NCT05477576
• Lead Sponsor: RayzeBio, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-24
• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-12
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 1b - RYZ101	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.
Phase 3 - RYZ101	RYZ101	Actinium 225 radiolabeled somatostatin analog (SSA) for injection
Phase 3 - Standard of Care	Everolimus	Investigator's choice of standard of care between everolimus, sunitinib, octreotide, or lanreotide.
Phase 3 - Standard of Care	Sunitinib	Investigator's choice of standard of care between everolimus, sunitinib, octreotide, or lanreotide.
Phase 3 - Standard of Care	Octreotide	Investigator's choice of standard of care between everolimus, sunitinib, octreotide, or lanreotide.
Phase 3 - Standard of Care	Lanreotide	Investigator's choice of standard of care between everolimus, sunitinib, octreotide, or lanreotide.

Primary Outcome Measures

Name	Time	Method
Phase 1b: RP3D	56 days of study treatment	Incidence of DLTs during the first 56 days of study treatment will be assessed.
Phase 3: PFS as determined by BICR	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.

Trial Locations

Locations (1)

Research Facility; 🇪🇸 Zaragoza, Spain