Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called SGR-1505 (the study drug). We want to know how well this study drug specifically targets a protein related to your B-cell cancer.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with a B-cell malignancy that has returned after treatment or does not respond to treatment</li>
<li>Have tried at least 2 different lines of treatment without success and are not eligible for any available standard treatment</li>
<li>Have not received a hematopoietic stem cell transplant and chimeric antigen receptor therapy within 90 days starting the study drug regimen</li></ul>
For more information about who can join this study, please contact the study team at 919-681-6580.
<li>Are diagnosed with a B-cell malignancy that has returned after treatment or does not respond to treatment</li>
<li>Have tried at least 2 different lines of treatment without success and are not eligible for any available standard treatment</li>
<li>Have not received a hematopoietic stem cell transplant and chimeric antigen receptor therapy within 90 days starting the study drug regimen</li></ul>
For more information about who can join this study, please contact the study team at 919-681-6580.
What is Involved?
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:<ul>
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li></ul>
After the screening period, you will participate in the pharmacokinetic (PK) Run-in period which is dedicated to evaluate how your body processes the study drug. You will be given a single dose of study drug. You will return to the study clinic for the next 4 mornings for procedures and blood tests.
After the PK run-in period, the next phase is the study drug period beginning with Cycle 1, Day 1 (every 21 days). You will take the same dose of study drug by mouth at the same time every day. Your participation in the study will last until your disease worsens, you have severe side effects, you decide to withdraw, or the study ends.
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li></ul>
After the screening period, you will participate in the pharmacokinetic (PK) Run-in period which is dedicated to evaluate how your body processes the study drug. You will be given a single dose of study drug. You will return to the study clinic for the next 4 mornings for procedures and blood tests.
After the PK run-in period, the next phase is the study drug period beginning with Cycle 1, Day 1 (every 21 days). You will take the same dose of study drug by mouth at the same time every day. Your participation in the study will last until your disease worsens, you have severe side effects, you decide to withdraw, or the study ends.
Study Details
Full Title
A PHASE 1, OPEN-LABEL, MULTICENTER, DOSE ESCALATION STUDY OF SGR-1505 AS
MONOTHERAPY IN SUBJECTS WITH MATURE B-CELL MALIGNANCIES
MONOTHERAPY IN SUBJECTS WITH MATURE B-CELL MALIGNANCIES
Principal Investigator
Matthew
McKinney
Protocol Number
PRO00113371
NCT ID
NCT05544019
Phase
I
Enrollment Status
Open to Enrollment