Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2032-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation, Dose Expansion

Group Type EXPERIMENTAL

RYZ401

Intervention Type DRUG

Ac-225

Interventions

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RYZ401

Ac-225

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No