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).

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507702-13-00

Acronym

LOXO-RET-17001

Enrollment

128

Registered

2024-04-09

Start date

2017-09-22

Completion date

Unknown

Last updated

2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male or female patients age 12 years or older with a locally advanced or metastatic solid tumor with evidence of a RET gene alteration in tumor and/or blood.

Brief summary

1. Phase 1: MTD/RP2D., 2. Phase 2: ORR based on RECIST 1.1 or RANO, as appropriate to tumor type, assessed by IRC.

Interventions

DRUGSELPERCATINIB

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Phase 1: MTD/RP2D., 2. Phase 2: ORR based on RECIST 1.1 or RANO, as appropriate to tumor type, assessed by IRC.	—

Countries

Denmark, France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026