OncRef

Clinical Trial: NCT03157128

A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:Eli Lilly and Company
Information Provided By:Eli Lilly and Company
Last Update Posted:2026-04-16

Study Overview

Brief Summary

This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

Official Title

A Phase 1/2 Study of Oral Selpercatinib (LOXO-292) in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation (LIBRETTO-001)

Conditions

Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Any Solid Tumor

Intervention / Treatment

  • Drug: LOXO-292

Other Study ID Numbers

  • 17477
  • J2G-OX-JZJA
  • LOXO-RET-17001
  • 2017-000800-59
  • 2023-507702-13-00
  • 2023
  • 2017

Start Date (Actual)

2017-05-02

Primary Completion Date (Actual)

2025-02-14

Study Completion Date (Estimated)

2027-02

Enrollment (Actual)

857

Study Type

Interventional

Phase

Phase 1, Phase 2