A Study of Prexasertib (LY2606368), CHK1 Inhibitor, and LY3300054, PD-L1 Inhibitor, in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03495323|
Recruitment Status : Active, not recruiting
First Posted : April 12, 2018
Last Update Posted : February 5, 2020
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)
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: LY3300054 Drug: Prexasertib||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Combination Study of Prexasertib (LY2606368), CHK1 Inhibitor, and LY3300054, PD-L1 Inhibitor, in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||May 16, 2018|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||April 30, 2024|
Experimental: Prexasertib + LY3300054
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
- Dose Limiting Toxicity [ Time Frame: 2 years ]
- Pharmacokinetics of prexasertib and LY3300054 [ Time Frame: 2 years ]Pharmacokinetic Sampling - Peak Plasma Concentration (Cmax)
- Pharmacokinetics of prexasertib and LY3300054 [ Time Frame: 2 years ]Pharmacokinetic Sampling - Area Under the Plasma Concentration versus Time Curve (AUC)
- Changes in PD-L1 expression in paired pre- and on-treatment biopsies [ Time Frame: 2 years ]
- H2AX expression levels in paired tumor biopsies as a consequence of treatment with prexasertib as proof-of-principle of target engagement [ Time Frame: 2 years ]
- Changes in immune markers through analysis of T-cell subsets in paired tumor biopsies [ Time Frame: 2 years ]
- Changes in cytokine profile in peripheral blood samples [ Time Frame: 2 years ]
- Changes in immune markers through analysis of T-cell subsets in peripheral blood and tumor tissue [ Time Frame: 2 years ]
- Differences in immune markers between responders and non-responders [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495323
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Khanh T Do, MD||Dana-Farber Cancer Institute|