Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.

RayzeBio

Status and phase: Not yet enrolling; Phase 1

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

Treatments: Drug: RYZ401

Study type: Interventional

Funder types: Industry

Identifiers

NCT07165132

RYZ401-101

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years old at the time of signing the main study informed consent form (ICF).

• Histologically confirmed:

  • Grades 1-3 WD NETs (dose escalation and dose expansion)
  • Meningioma (dose expansion only)

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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104 participants in 1 patient group

Dose Escalation, Dose Expansion

Experimental group

Treatment:

Drug: RYZ401