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RYZ101

Phase 3

GEP-NET | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Mar 17, 2026

RYZ101 development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since Jul 2001

RYZ101 target and mechanism

ModalitySmall molecule

Also known as RYZ101 Dose Level 1

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials3
Total Enrollment353

FDA Designations

ORPHAN_DRUG

RYZ101 clinical trials

RYZ101 · 3 trials · 12 indications

Phase 3 1Phase 1/2 1Phase 1 1
NCT05477576Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA TherapyGEP-NET
RECRUITING288 Analytics
PHASE3RECRUITING
Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
GEP-NETUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
RYZ101DRUGRP3D as determined in Phase 1b
EverolimusDRUGEverolimus
SunitinibDRUGSunitinib
OctreotideDRUGHigh-dose octreotide
LanreotideDRUGLanreotide
RYZ101 Dose Level 1DRUGDose Level 1
RYZ101 Dose Level 2DRUGDose Level 2
RYZ101 Dose Level 3DRUGDose Level 3
RYZ101 Dose Level -1DRUGDose Level -1
AtezolizumabDRUGAtezolizumab
CarboplatinDRUGCarboplatin
EtoposideDRUGEtoposide
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Frequently asked questions about RYZ101

What is RYZ101 used for?

RYZ101 is an investigational oncology therapy being studied in gastroenteropancreatic neuroendocrine tumors (GEP-NET), ER-positive HER2-negative metastatic breast cancer, and extensive-stage small cell lung cancer. It is being developed by Bristol-Myers Squibb Company (BMY) and holds an orphan drug designation from the FDA.

What does RYZ101 target?

RYZ101 is a small molecule that targets somatostatin receptors (SSTRs). It is designed to deliver radiation to SSTR-expressing tumors. The trials enroll patients whose tumors express SSTRs, including SSTR-positive GEP-NET and SSTR-positive extensive-stage small cell lung cancer.

Who is developing RYZ101?

RYZ101 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is running clinical trials of RYZ101 in GEP-NET, metastatic breast cancer, and extensive-stage small cell lung cancer.

What phase is RYZ101 in?

RYZ101 is in Phase 3 development. The Phase 3 trial is evaluating RYZ101 compared with standard of care in patients with inoperable SSTR-positive well-differentiated GEP-NET that has progressed following 177Lu-SSA therapy. RYZ101 is investigational and has not been approved by the FDA.

What clinical trials is RYZ101 in?

RYZ101 is being studied in three clinical trials. NCT05477576 is a Phase 3 trial in SSTR-positive well-differentiated GEP-NET. NCT05595460 is a Phase 1 trial in SSTR-positive extensive-stage small cell lung cancer. NCT06590857 is a Phase 1/2 trial in ER-positive HER2-negative metastatic breast cancer expressing SSTRs.

Is RYZ101 the same as RYZ101 Dose Level 1?

RYZ101 Dose Level 1 is an alternative name used for RYZ101. Both refer to the same investigational therapy developed by Bristol-Myers Squibb Company (BMY) for SSTR-expressing tumors, including GEP-NET, metastatic breast cancer, and extensive-stage small cell lung cancer.