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Cola

Phase 1 dose escalation - Multiple doses of LY3410738

Phase 1 dose expansion - The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of LY3410738 alone or in combination with gemcitabine plus cisplatin or in combination with durvalumab

LY3410738

Hui Liu

This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with isocitrate dehydrogenase 1 (IDH1) arginine 132 (R132)-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or isocitrate dehydrogenase 2 (IDH2) arginine 140 (R140) or arginine 172 (R172) mutant cholangiocarcinoma.

This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with IDH1 R132-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or IDH2 R140 or R172 mutant cholangiocarcinoma.

This study includes 2 parts: Phase 1 dose escalation and Phase 1 dose expansion. The Phase 1 dose escalation monotherapy cohort will enroll any eligible patient with IDH1 R132-mutant advanced solid tumor or IDH1 or IDH2 mutant cholangiocarcinoma. The Phase 1 dose expansion will include 5 cohorts to further evaluate safety and clinical activity. Three cohorts will be administered LY3410738 monotherapy. The fourth cohort will administer LY3410738 at or below the monotherapy RP2D in combination with gemcitabine and cisplatin. The fifth cohort (US only) will administer LY3410738 at or below the monotherapy RP2D in combination with durvalumab.

IDH1 R132, IDH2 R140, or IDH2 R172 mutations will be identified through genomic testing utilizing material collected prior to patient consent. Molecular assays utilized for enrollment are required to be performed in CLIA, ISO/IEC, CAP, or other similarly certified laboratory. Enrollment of patients with cholangiocarcinoma, chondrosarcoma or glioma may be made based on molecular tests performed in either tumor or blood. Enrollment of patients with other tumor types is limited to testing performed in tumor tissue.

Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

A Phase 1 Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

Loxo Oncology, Inc.

Eli Lilly and Company

Respiratory Tract (Lung and Bronchial) Diseases

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Carcinoma, Non-Small-Cell Lung

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Neuroepithelioma

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)

Nervous System Neoplasms

ONO-7579

Protein Kinase Inhibitors

Enzyme Inhibitors

Drug Development Division

This study will determine the safety and maximum tolerated dose of ONO-7579 in patients with advanced solid tumors, and evaluate efficacy of ONO-7579 in patients with advanced solid tumors harboring NTRK gene fusions.

The trial was designed to be a Phase 1/2 trial, but was terminated without progressing to Phase 2.

Study of ONO-7579 in Patients With Advanced Solid Tumors/ NTRK Gene Fusion Positive Advanced Solid Tumors

An Open-label, Multi-center, Dose-escalation and Expansion Study to Evaluate the Safety and Efficacy of ONO-7579 in Patients With Advanced Solid Tumors/ NTRK Gene Fusion Positive Advanced Solid Tumors

To investigate the safety and tolerability of ONO-7579 to determine MTD/RCD

Assessed by Independent Central Review using RECIST 1.1 or RANO criteria

Assessment of the maximum plasma concentration of ONO-7579

Assessment of the time to reach maximum observed plasma concentration of ONO-7579

Assessment of the plasma area under the curve from time zero to 24 hours after dosing

Assessment of the plasma decay half life of ONO-7579

Assessment of the trough concentration of ONO-7579 in plasma

Assessed by investigator using RECIST 1.1 or RANO criteria

To determine the safety and tolerability of ONO-7579

Ono Pharmaceutical Co. Ltd

Adenoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations	NCT04521686	Cholangiocarcin... Chondrosarcoma Glioma Any Solid Tumor	LY3410738 Gemcitabine Cisplatin Durvalumab	18 Years -	Eli Lilly and Company
A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)	NCT03157128	Non-Small Cell ... Medullary Thyro... Colon Cancer Any Solid Tumor	LOXO-292	12 Years -	Eli Lilly and Company
Study of ONO-7579 in Patients With Advanced Solid Tumors/ NTRK Gene Fusion Positive Advanced Solid Tumors	NCT03182257	Solid Tumor	ONO-7579	18 Years -	Ono Pharmaceutical Co. Ltd
Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations	NCT04521686	Cholangiocarcin... Chondrosarcoma Glioma Any Solid Tumor	LY3410738 Gemcitabine Cisplatin Durvalumab	18 Years -	Eli Lilly and Company
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors	NCT03899792	Medullary Thyro... Infantile Myofi... Infantile Fibro... Papillary Thyro... Soft Tissue Sar...	LOXO-292	6 Months - 21 Years	Eli Lilly and Company
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors	NCT03899792	Medullary Thyro... Infantile Myofi... Infantile Fibro... Papillary Thyro... Soft Tissue Sar...	LOXO-292	6 Months - 21 Years	Eli Lilly and Company
Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors	NCT02502708	Glioblastoma Mu... Glioma Gliosarcoma Malignant Brain... Ependymoma Medulloblastoma Diffuse Intrins... Primary CNS Tum...	Indoximod Temozolomide Conformal Radia... Cyclophosphamid... Etoposide	3 Years - 21 Years	Lumos Pharma
Study of ONO-7579 in Patients With Advanced Solid Tumors/ NTRK Gene Fusion Positive Advanced Solid Tumors	NCT03182257	Solid Tumor	ONO-7579	18 Years -	Ono Pharmaceutical Co. Ltd
Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors	NCT02502708	Glioblastoma Mu... Glioma Gliosarcoma Malignant Brain... Ependymoma Medulloblastoma Diffuse Intrins... Primary CNS Tum...	Indoximod Temozolomide Conformal Radia... Cyclophosphamid... Etoposide	3 Years - 21 Years	Lumos Pharma

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