Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Carcinoma

Lung Neoplasms

Triple Negative Breast Neoplasms

Carcinoma, Renal Cell

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Breast Diseases

Skin Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Antibodies

Immunoglobulins

LY3381916 administered orally and LY3300054 administered intravenously (IV).

Metastatic triple negative breast cancer (TNBC)

LY3381916 administered orally and LY3300054 administered IV.

Metastatic non-small cell lung cancer (NSCLC)

LY3381916 administered orally and LY3300054 administered IV.

Metastatic clear cell carcinoma renal cell carcinoma (RCC)

LY3381916 administered orally and LY3300054 administered IV.

LY3381916

LY3300054

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 purpose of this study is to evaluate the safety of the study drug LY3381916 administered alone or in combination with anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody (LY3300054).

A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors

A Phase 1a/1b Study of an Anti-IDO-1 Agent (LY3381916) Administered Alone or in Combination With Anti- PD-L1 Checkpoint Antibody (LY3300054) in Solid Tumors

PK: Cmax of LY3381916 administered in combination with LY3300054

PK: AUC of LY3381916 administered in combination with LY3300054

PK: Cmax of LY3300054 administered in combination with LY3381916

PK: Cmin of LY3300054 administered in combination with LY3381916

ORR: Percentage of participants with a CR or PR

DCR: Percentage of participants who exhibit SD, CR or PR

Eli Lilly and Company

Antibodies, Monoclonal

Prexasertib

Protein Kinase Inhibitors

Enzyme Inhibitors

* Prexasertib is administered intravenously twice per cycle
* LY3300054 is administered intravenously twice per cycle

LY3300054 is a monoclonal antibody that targets programmed cell death ligand 1 (

Prexasertib work by preventing the cancer cells from being able to repair damaged DNA (one of the building blocks of a cell) which then leads to cell death

Geoffrey T Shapiro, MD

This research study is studying a combination of a targeted therapy and an immune therapy as a possible treatment.

The drugs involved in this study are:

* Prexasertib (LY2606368)
* LY3300054

This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate doses of the investigational drugs to use for further studies. "Investigational" means that the drugs are being studied.

The FDA (the U.S. Food and Drug Administration) has not approved prexasertib or LY3300054 as a treatment for any disease.

Prexasertib (LY2606368) is a checkpoint kinase 1 (CHK1) inhibitor that is being developed as a treatment for patients with advanced cancer. CHK1 inhibitors work by preventing the cancer cells from being able to repair damaged DNA (one of the building blocks of a cell) which then leads to cell death.

A monoclonal antibody is a protein that is made in a laboratory that can target specific substances in the body. LY3300054 is a monoclonal antibody that targets programmed cell death ligand 1 (PD-L1). PD-L1 is a protein often produced by cancer cells or surrounding cells that stops white blood cells from attacking the cancer cells. The drug blocks the protein, allowing the immune system to recognize and attack the cancer cells.

A Study of Prexasertib (LY2606368), CHK1 Inhibitor, and LY3300054, PD-L1 Inhibitor, in Patients With Advanced Solid Tumors

A Phase I Combination Study of Prexasertib (LY2606368), CHK1 Inhibitor, and LY3300054, PD-L1 Inhibitor, in Patients With Advanced Solid Tumors

Pharmacokinetic Sampling - Peak Plasma Concentration (Cmax)

Pharmacokinetic Sampling - Area Under the Plasma Concentration versus Time Curve (AUC)

Dana-Farber Cancer Institute

Principal Investigator

LY3321367

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 purpose of this study is to evaluate the safety of the study drug known as LY3321367, an anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in participants with advanced relapsed/refractory solid tumors.

A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors

A Phase 1a/1b Study of LY3321367, an Anti-TIM-3 Antibody, Administered Alone or in Combination With LY3300054, an Anti-PD-L1 Antibody, in Advanced Relapsed/Refractory Solid Tumors

Dose Limiting Toxicity (DLT) is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3321367

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3321367 in Combination with LY3300054

Objective Response Rate (ORR) is the percentage of participants with confirmed best overall tumor response of Complete Response (CR) or Partial Response (PR).

Progression Free Survival (PFS) is defined as the date of the first dose to the first date of objectively determined progressive disease or death from any cause, whichever is earlier.

Duration of Response (DoR) is defined as the time from the date of the first CR or PR to the first date of progressive disease (PD) or death from any cause.

Time to Response (TTR) is defined as time from treatment start to first documentation of response.

Disease Control Rate (DCR) is the percentage of participants with stable disease (SD), confirmed PR or confirmed CR (CR+PR+SD).

Camurati-Engelmann Disease

Antineoplastic Agents

Paclitaxel

Gemcitabine

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

LY3200882

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors	NCT03343613	Solid Tumor Non Small Cell ... Renal Cell Carc... Triple Negative...	LY3381916 LY3300054	18 Years -	Eli Lilly and Company
A Study of Prexasertib (LY2606368), CHK1 Inhibitor, and LY3300054, PD-L1 Inhibitor, in Patients With Advanced Solid Tumors	NCT03495323	Cancer	LY3300054 Prexasertib	18 Years -	Dana-Farber Cancer Institute
A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors	NCT03343613	Solid Tumor Non Small Cell ... Renal Cell Carc... Triple Negative...	LY3381916 LY3300054	18 Years -	Eli Lilly and Company
A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors	NCT03099109	Solid Tumor	LY3321367 LY3300054	18 Years -	Eli Lilly and Company
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 ly3300054

Every month we try and update this database with for ly3300054 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 ly3300054

Every month we try and update this database with for ly3300054 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 ly3300054 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.