Purpose of this Study
We are doing this study to find out if an experimental drug called ABBV-CLS-484 (the study drug) is a safe and effective option for patients who have certain types of cancers that involve solid tumors, such as head and neck, lung, or kidney cancers. This study will also help determine what dose of the study drug works best when it is given either alone or in combination with pembrolizumab or cabozantinib.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with a solid tumor form of cancer, such as head and neck, lung, or renal cell cancer</li>
<li>Weigh at least 77 pounds</li></ul>
For more information about who can join this study, contact the study team at <a href= "mailto: kellie.shobe@duke.edu">kellie.shobe@duke.edu.</a>
<li>Are diagnosed with a solid tumor form of cancer, such as head and neck, lung, or renal cell cancer</li>
<li>Weigh at least 77 pounds</li></ul>
For more information about who can join this study, contact the study team at <a href= "mailto: kellie.shobe@duke.edu">kellie.shobe@duke.edu.</a>
What is Involved?
If you choose to join the study and are eligible, you will get a random assignment (like a coin flip) to 1 of 2 groups. Participants assigned to Group 1 will get only the study drug, and participants assigned to Group 2 will get the study drug in combination with pemborlizumab or cabozantinib.
If you are in Group 1, you will get another random assignment for how you receive the study drug. You might:<ul>
<li>Take the study drug every day for 21 days ("Continuous QD 21-Day Cycle"); OR</li>
<li>Take the study drug every other day for 28 days ("Intermittent Q2D 28-Day Cycle"); OR</li>
<li>Alternate between taking the study drug for 4 days in a row and then taking no drug for 10 days over 28 days ("Intermittent 4 Days On/10 Days Off 28-Day Cycle"); OR</li>
<li>Alternate between taking the study drug for 4 days in a row and then taking no drug for 3 days over 28 days ("Intermittent 4 Days On/3 Days Off 28-Day Cycle")</li></ul>
If you are in Group 2, you will also get a random assignment for how you receive the study drug that is identical to one of the assignment options in Group 1, except you will also take pembrolizumab or cabozantinib according to their dosing instructions while you get the study drug.
If you are in Group 1, you will get another random assignment for how you receive the study drug. You might:<ul>
<li>Take the study drug every day for 21 days ("Continuous QD 21-Day Cycle"); OR</li>
<li>Take the study drug every other day for 28 days ("Intermittent Q2D 28-Day Cycle"); OR</li>
<li>Alternate between taking the study drug for 4 days in a row and then taking no drug for 10 days over 28 days ("Intermittent 4 Days On/10 Days Off 28-Day Cycle"); OR</li>
<li>Alternate between taking the study drug for 4 days in a row and then taking no drug for 3 days over 28 days ("Intermittent 4 Days On/3 Days Off 28-Day Cycle")</li></ul>
If you are in Group 2, you will also get a random assignment for how you receive the study drug that is identical to one of the assignment options in Group 1, except you will also take pembrolizumab or cabozantinib according to their dosing instructions while you get the study drug.
Study Details
Full Title
A Phase 1 Study with ABBV-CLS-484 Alone and in Combination in Subjects with Locally Advanced or Metastatic Tumors
Principal Investigator
Michael
Harrison
Protocol Number
PRO00114346
NCT ID
NCT04777994
Phase
I
Enrollment Status
Pending Open to Enrollment