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Cola

Phase 1 - Multiple doses of LOXO-292 (selpercatinib) Phase 2 - The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)

LOXO-292

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Nina Karlin

Erminia Massarelli

Lyudmila Bazhenova

Jonathan Goldman

Michael Demeure

Misako Nagasaka

Hyunseok Kang

Minggui Pan

Jennifer Suga

Gerald Falchook

Frederick Wilson

Benjamin Levy

Victor Bernet

Luis Raez

Conor Steuer

Christine Bestvina

Marc Matrana

Ranee Mehra

Lori Wirth

Jacob Sands

Francis Worden

Nehal Lakhani

John Columbus Morris

Saiama Waqar

Fadi Braiteh

Grace Dy

Vamsidhar Velcheti

Alexander Drilon

Jared Weiss

Nathan Pennell

Vineeth Sukrithan

Shivaani Kummar

Devraj Basu

Marcia Brose

Jordan Berlin

Tian Zhang

Vivek Subbiah

Wallace Akerley

Alexander Spira

Mark Burkard

bruce robinson

Benjamin Solomon

Janessa Laskin

Kristoffer Rohrberg

Jacques Medioni

Antoine Italiano

Philippe Cassier

Pascale Tomasini

Diego Tosi

Benjamin Besse

Barbara Deschler-Baier

Jürgen Wolf

Herbert Loong

Talia Golan

Nir Peled

Julia Dudnik

Hovav Nechushtan

Filippo De Braud

Masahiro Morise

Koichi Goto

Jun Sakakibara

Miyako Satouchi

Shinji Takeuchi

Tsutomu Iwasa

Hirotsugu Kenmotsu

YUICHIRO OHE

Makoto Nishio

Tomohiro Sakamoto

Ryo Toyozawa

Kadoaki Ohashi

Haruko Daga

Ji-Youn Han

Yu Jung Kim

Dae Ho Lee

Se Hoon Lee

Byoung Chul Cho

Shao Weng Daniel Tan

Elena Garralda Cabanas

Victor Moreno

Maria Jose de Miguel Luken

Oliver Gautschi

Kuo-Hsuan Hsu

Chih-Hsin Yang

Anna Minchom

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

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.

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 875 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 other than NSCLC or thyroid cancer for participants who progressed on or intolerant to first line therapy (open)
* Cohort 2: Advanced RET fusion positive solid tumor other than NSCLC or thyroid cancer 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 other than NSCLC or thyroid cancer and RET-mutant MEN2 spectrum tumors (e.g. pheochromocytoma) 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 (closed)
* 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 (closed)

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

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)

Incidence rate and category of dose limiting toxicities (DLTs) during the first 28-day cycle of LOXO-292 (selpercatinib) treatment

As assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (RANO), as appropriate to tumor type, as assessed by independent review committee (IRC)

Phase 1: Number of Participants with a TRAE(s)

Phase 1: Number of Participants with an Abnormal Laboratory or Physical Exam Result(s)

Phase 1: ORR based on RECIST 1.1 or RANO, as Appropriate to Tumor Type

Phase 2: Best Change in Tumor Size from Baseline (by IRC and Investigator)

Phase 2: Time to Any and Best Response (by IRC and Investigator)

Phase 2: Percentage of Participants with any SAE(s)

Phase 1 and 2: PK: AUC of LOXO-292 (Selpercatinib)

Phase 1 and 2: PK: Cmax of LOXO-292 (Selpercatinib)

Eli Lilly and Company

Loxo Oncology, Inc.

Spots Global Cancer Trial Database for thyroid ademona