Treatment with ATR Inhibitor for Advanced or Metastatic Solid Tumors identifier:
NCT04657068 (

Advanced solid tumors

Study Contact Information:

For additional information, please contact:

Sarah Cannon Development Innovations by phone: 844-710-6157 or by email

About the Study

This study will look at how well a new oral targeted therapy known as an ATR inhibitor works on advanced or metastatic solid tumors with mutations in genes linked to DNA damage repair. The study will look at response to treatment with the drug ART0380 either alone or in combination with the chemotherapy agent, gemcitabine. 

Type of Study

This is an open-label, non-randomized study.

Participant groups:

What the Study Entails:

All participants in this study will receive ART0380 orally either intermittently (once daily 3 days on, 4 days off or days 2-4 and 9-11) or continuously (once daily each day) in 21 day cycles. 

Group A1

Group A2

Group B1

Group B2 

All study participants will be followed for up to 24 months.

Study Sites

Denver, Colorado
Sarah Cannon Research Institute at HealthONE 
Principal Investigator: Gerald Falchook, MD
[email protected]

Orlando, Florida
Florida Cancer Specialists 
Principal Investigator: Cesar Perez, MD
[email protected]

Sarasota, FL
Florida Cancer Specialists
Principal Investigator: Manish Patel, MD
[email protected]

Oklahoma City, OK
Stephenson Cancer Center      
Principal Investigator: Kathleen Moore, MD
[email protected]

Nashville, TN
Tennessee Oncology
Principal Investigator: Melissa Johnson, MD
[email protected]

This Study is Open To:

People may be eligible if they:

Additional inclusion criteria for participants in Group A1:

Additional inclusion criteria for participants in dose escalation (Part A2):

Additional inclusion criteria for participants in dose expansion (Part B1):

Additional inclusion criteria for participants in dose expansion (Part B2):

This Study is Not Open To:

People with the following are not eligible for the study:


FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.