Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Camurati-Engelmann Disease

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Antimetabolites

TGF-beta activated advanced colorectal cancer with LY3200882 and capecitabine

Combination treatment with LY3200882 and capecitabine

LY3200882

Neeltje Steeghs, MD, PhD

Sanne Huijberts, MD

J Tabernero, Prof

R Bernards, Prof

R Salazar, MD, PhD

S Siena, Prof

A Cervantes, Prof

F Ciardello, Prof

A Bardelli, Prof

S Tejpar, Prof

Part I of this study is designed to identify the recommended phase 2 dose (RP2D) of the combination regimen of LY3200882/capecitabine as second line treatment in patients with 5-FU or capecitabine resistant CRC. Part II is designed to obtain proof of principle of the LY3200882 plus capecitabine combination in patients with chemo-resistant CRC. The combination of LY3200882 plus capecitabine will be given as second line therapy in the phase II part of this study.

Patients with chemotherapy resistant activated TGF-β signature-like tumors will have received a fluoropyrimidine (5FU or capecitabine) in the first line of chemotherapy, usually combined with oxaliplatin and, depending upon local hospital preferences or national guidelines, also bevacizumab, or cetuximab/panitumumab if the tumor is KRAS wild type. Addition of LY3200882 to capecitabine should thus result in reversal of unresponsiveness, which is the first step in exploring this concept in the clinic. Capecitabine can be used as single agent in advanced CRC and is thus attractive for this study concept. If proof of principle is achieved also other tumor types can be explored with this genetic makeup, such as non-small cell lung cancer (NSCLC) in second line of treatment after platinum doublet therapy in first line, usually cisplatin/carboplatin-pemetrexed in non-squamous and cisplatin/carboplatin-gemcitabine or cisplatin/carboplatin-paclitaxel in squamous type NSCLC.

LY3200882 and Capecitabine in Advanced Resistant TGF-beta Activated Colorectal Cancer (EORTC1615)

MoTriColor: Phase I/II Study With LY3200882 Combined With Capecitabine in Patients With Advanced Chemotherapy Resistant Colorectal Cancer and an Activated TGF-beta Signature

Vall d'Hebron Institute of Oncology

Agendia

European Organisation for Research and Treatment of Cancer - EORTC

Azienda Ospedaliera Niguarda Cà Granda

Fundación para la Investigación del Hospital Clínico de Valencia

University of Campania "Luigi Vanvitelli"

University of Turin, Italy

Eli Lilly and Company

Catalan Institute of Health

Universitaire Ziekenhuizen KU Leuven

The Netherlands Cancer Institute

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Transitional Cell

Lung Neoplasms

Carcinoma, Hepatocellular

Transitional Cell Carcinoma

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered intravenously (IV).

Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered IV.

Participants with urothelial carcinoma, non-small cell lung cancer, or hepatocellular carcinoma: LY3200882 administered orally twice in combination with pembrolizumab administered IV.

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)

The main purpose of this study is to see if the drug LY3200882 which is an inhibitor of transforming growth factor-β (TGFβ) receptor 1 in combination with pembrolizumab is safe and effective in participants with cancer that has spread to other parts of the body.

A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer

Phase 1b/2 Study of LY3200882 and Pembrolizumab in Patients With Advanced Cancer

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

ORR: Percentage of Participants with CR or PR

PK: Cmax of LY3200882 in Combination With Pembrolizumab

Merck Sharp & Dohme LLC

Paclitaxel

Gemcitabine

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

LY3300054

nab-Paclitaxel

Intensity Modulated Radiotherapy

The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.

A Study of LY3200882 in Participants With Solid Tumors

A Phase 1 Study of LY3200882 in Patients With Solid Tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
LY3200882 and Capecitabine in Advanced Resistant TGF-beta Activated Colorectal Cancer (EORTC1615)	NCT04031872	Colorectal Canc...	LY3200882	18 Years -	The Netherlands Cancer Institute
A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer	NCT04158700	Advanced Cancer	LY3200882 Pembrolizumab	18 Years -	Eli Lilly and Company
LY3200882 and Capecitabine in Advanced Resistant TGF-beta Activated Colorectal Cancer (EORTC1615)	NCT04031872	Colorectal Canc...	LY3200882	18 Years -	The Netherlands Cancer Institute
A Study of LY3200882 in Participants With Solid Tumors	NCT02937272	Solid Tumor	LY3200882 LY3300054 Gemcitabine nab-Paclitaxel Cisplatin Intensity Modul...	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for ly3200882

Every month we try and update this database with for ly3200882 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ly3200882

Every month we try and update this database with for ly3200882 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ly3200882 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.