Status: Active Trial | Marker:


A Phase 1/2 Study of Oral 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).

Study Number

Patients with a locally advanced or metastatic RET Fusion-Positive solid tumors

Primary objective

To assess, for each phase 2 expansion cohort, the anti-tumor activity of LOXO-292 by determining ORR using RECIST 1.1 or RANO, as appropriate to tumor type, as assessed by independent review committee (IRC).

In- and exclusion Criteria

Prior MKIs with anti-RET activity are allowed. Refer to Appendix A for examples of MKIs with anti-RET activity. However, prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s]) is prohibited

Study design
Phase 2, open, multicentre

Loxo Oncology
Inc. 281 Tresser Boulevard, 9th Floor
Stamford, CT 06901

Trial Centre

Universitätsklinikum Köln
Klinik I für Innere Medizin/LCGC
Telefon: +49 221 478 87008
Fax: +49 221 478 87010

Principal investigator

Prof. J. Wolf

Last Update: 23. August 2019