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


Active: Yes
Cancer Type: Brain & Spinal Cord Tumor
Colon/Rectal Cancer
Head and Neck Cancer
Lung Cancer
Neuroendocrine Tumor
Solid Tumor
Thyroid Cancer
Unknown Primary
NCT ID: NCT03157128
Trial Phases: Phase I
Phase II
Protocol IDs: LOXO-RET-17001 (primary)
NCI-2017-00976
2017-000800-59
Eligibility: 12 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Loxo Oncology, Inc.
NCI Full Details: http://clinicaltrials.gov/show/NCT03157128

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.

Objectives

This is an open-label, multi-center Phase 1/2 study in participants with advanced solid
tumors, including RET fusion-positive solid tumors, MTC, and other tumors with RET
activation. The trial will be conducted in 2 parts: Phase 1 (dose escalation - completed) and
phase 2 (dose expansion). Participants with advanced cancer are eligible if they have
progressed on or are intolerant to available standard therapies, or no standard or available
curative therapy exists, or in the opinion of the Investigator, they would be unlikely to
tolerate or derive significant clinical benefit from appropriate standard of care therapy, or
they declined standard therapy. A dose of 160 milligrams (mg) twice a day (BID) has been
selected as the recommended phase 2 dose (RP2D). Approximately 950 participants with advanced
solid tumors harboring a RET gene alteration in tumor and/or blood will be enrolled to one of
seven phase 2 cohorts:

- Cohort 1: Advanced RET fusion positive solid tumor for participants who progressed on or
intolerant to first line therapy (open)

- Cohort 2: Advanced RET fusion positive solid tumor for treatment naïve participants
(open)

- Cohort 3: Advanced RET-mutant MTC participants who progressed on or intolerant to first
line therapy (closed)

- Cohort 4: Advanced RET-mutant MTC participants who are treatment naïve (closed)

- Cohort 5: Advanced RET-altered solid tumor for participants otherwise ineligible for
cohorts 1-4. See details in inclusion/exclusion criteria (open)

- Cohort 6: Participants otherwise eligible for Cohorts 1-5 who discontinued another RET
inhibitor due to intolerance may be eligible with prior Sponsor approval (open)

- Cohort 7: RET fusion positive early-stage non-small cell lung cancer (NSCLC)
participants who are candidates for definitive surgery. Participants will receive
selpercatinib in a neoadjuvant and adjuvant setting. Participants will be followed for
disease recurrence for up to 5 years from the date of surgery (open)

Treatment Sites in Georgia

Emory University School of Medicine
1440 Clifton Road
Atlanta, GA 30322


**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.