Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.

Not Applicable

Not yet recruiting

• Conditions: Carcinoid Tumor; Pancreatic NET; Solid Tumor; Somatostatin Receptor; GEP-NET; Gastroenteropancreatic Neuroendocrine Tumor; Gastroenteropancreatic Neuroendocrine Tumor Disease; Neuroendocrine Tumors; Carcinoid
• Interventions: Drug: RYZ401

• Registration Number: NCT07165132
• Lead Sponsor: RayzeBio, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-20
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-10
• Study Start: 2025-10-01
• Primary Completion: 2027-02
• Study Completion: 2032-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation, Dose Expansion	RYZ401	-

Primary Outcome Measures

Name	Time	Method
Dose Escalation	Incidence of DLTs during the first 4 weeks of RYZ401 treatment	Incidence of DLTs during RYZ 401 Treatment
Dose Expansion	Cycle1 Day 1 to LPFV + 6 weeks	Incidence, severity, and duration of AEs