Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.

About

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Inclusion criteria:

At least 18 years old at the time of signing the main study informed consent form (ICF).
Histologically confirmed: Dose Escalation (all cohorts): Grades 1-3 WD, metastatic or locally advanced and unresectable NET at any primary site, including, but not limited to, GI, pancreatic, lung, thyroid, breast, urogenital, and adrenal tumors.
Dose Expansion Cohort A: Grades 1-3 WD, metastatic or locally advanced and unresectable GEP-NETs
Dose Expansion Cohort B: metastatic or locally advanced and unresectable tumors known to frequently express SSTR, limited to the following indications:
- WD NETs (Grades 1-3) from primary sites other than gastrointestinal and pancreatic (including, but not limited to, lung, thyroid, breast, urogenital, and adrenal tumors) Meningioma (Grades 1-3)
  - 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. Note: Additional criteria may apply and will be assessed by the study site