Investigational Pipeline

RYZ-101: an Ac-225 radioligand in clinical development.

RYZ-101 (225Ac-DOTATATE) is an investigational targeted alpha therapy designed to bind somatostatin receptor type 2 (SSTR2) — a receptor frequently expressed in neuroendocrine and other tumors.

Mechanism in brief

A targeted alpha approach to SSTR2-expressing tumors

Target

Somatostatin receptor type 2 (SSTR2), broadly expressed in gastroenteropancreatic neuroendocrine tumors and a subset of small cell lung cancer.

Ligand

DOTATATE, a somatostatin analog with high affinity for SSTR2.

Payload

Actinium-225, an alpha-emitting radionuclide delivering high-LET radiation locally to the bound tumor cell.

Clinical program

Ongoing studies

Study	Phase	Indication	Status	Design
ACTION-1	Phase 3	SSTR2+ GEP-NETs (2L+ after Lu-177)	Enrolling	Randomized vs investigator's choice; primary endpoint PFS.
ACTION-2	Phase 1b	Extensive-stage SCLC (ES-SCLC)	Recruiting	Dose escalation and expansion in pre-treated ES-SCLC.
GCC-SCLC	Phase 1	Select solid tumors (research collaborations)	In planning	Exploratory cohorts across SSTR2-expressing tumor types.

For complete study details, eligibility, and locations, please reference ClinicalTrials.gov. Trial information is for educational purposes only.

Investigational status

RYZ-101 is an investigational agent and has not been approved by the FDA or any other regulatory authority. The safety and efficacy of RYZ-101 have not been established. This page is for healthcare professional education and does not constitute promotion of an unapproved product or use.