Purpose of this Study
We are doing this study to find out if an investigational drug, CTX-471, is safe and effective against your cancer.
Who Can Participate?
Eligibility
Adults who have metastatic or locally advanced cancer who:
- Did not respond to prior treatment with a PD-1 or PD-L1 inhibitor
- Have not had other systemic anticancer therapy
- Did not respond to prior treatment with a PD-1 or PD-L1 inhibitor
- Have not had other systemic anticancer therapy
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will:
- Have an infusion of the study drug (CTX-471) once every 2 weeks
- Have a tumor biopsy
- Have an eye exam
- Have physical exams, blood and urine tests
- Have imaging scans (CT and/or MRI)
- Have tests of your heart (ECG)
- Have an infusion of the study drug (CTX-471) once every 2 weeks
- Have a tumor biopsy
- Have an eye exam
- Have physical exams, blood and urine tests
- Have imaging scans (CT and/or MRI)
- Have tests of your heart (ECG)
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-471 Administered Either as a Monotherapy or in Combination with Pembrolizumab in Patients with Inadequate Responses to PD-1/PD-L1 Checkpoint Inhibitors in Metastatic or Locally Advanced Malignancies
Principal Investigator
Niharika
Mettu
Protocol Number
PRO00103011
NCT ID
NCT03881488
Phase
I
Enrollment Status
OPEN TO ACCRUAL