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RYZ101

Phase 3

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

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

UNCONTROLLED
Total Trials1
Total Enrollment288

FDA Designations

No designations recorded

Clinical trial landscape

RYZ101 · 2 trials · 11 indications

Phase 3 1Phase 1/2 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
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Frequently asked questions about RYZ101

What is RYZ101 used for?

RYZ101 is an investigational small molecule being studied for gastroenteropancreatic neuroendocrine tumors (GEP-NET) and metastatic breast cancer. In GEP-NET, it is evaluated in patients with inoperable, somatostatin receptor-positive, well-differentiated disease that progressed after 177Lu-SSA therapy. In breast cancer, it is studied in ER-positive, HER2-negative unresectable or metastatic disease expressing somatostatin receptors.

What does RYZ101 target?

RYZ101 targets somatostatin receptors (SSTRs). Its clinical trials enroll patients whose tumors express these receptors, including those with somatostatin receptor-positive GEP-NET and breast cancer expressing SSTRs. The drug is designed to deliver a therapeutic payload to SSTR-expressing cancer cells.

Who makes RYZ101?

RYZ101 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials of RYZ101 in oncology indications.

What phase is RYZ101 in?

RYZ101 is in Phase 3 clinical development for GEP-NET, based on the ongoing study NCT05477576. It is also being studied in an earlier Phase 1/Phase 2 trial for metastatic breast cancer. RYZ101 remains investigational and has not been approved by regulatory authorities.

What clinical trials is RYZ101 in?

RYZ101 has two clinical trials. NCT05477576 is a Phase 3 study comparing RYZ101 with standard of care in patients with inoperable SSTR-positive GEP-NET that progressed after 177Lu-SSA therapy, with 288 participants. NCT06590857 is a Phase 1/Phase 2 trial in ER-positive, HER2-negative metastatic breast cancer expressing SSTRs, with 16 participants.

Is RYZ101 the same as RYZ101 Dose Level 1?

Yes, RYZ101 is also known as RYZ101 Dose Level 1. Both names refer to the same investigational drug being developed by Bristol-Myers Squibb for somatostatin receptor-positive tumors.