Purpose of this Study
We are doing this study to find out if an experimental drug called CRB-601 (the study drug) is a safe and effective option for people who have cancers with advanced solid tumors that did not improve with standard treatment.
Who Can Participate?
Eligibility
Adults ages 18-64 who:
- Are diagnosed with an advanced or metastatic solid tumor
- Had their disease progress after at least 1 line of previous treatment
Age Range
18-64
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get an assignment to 1 of 3 different dose levels of the study drug. These dose levels might be:
- 3 milligrams for each kilogram of body weight (3 mg/kg); OR
- 10 mg/kg; OR
- 30 mg/kg
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of CRB-601, a Monoclonal Antibody against Integrin avß8, in Patients with Advanced Solid Tumors
Principal Investigator
Jeffrey
Clarke
Protocol Number
PRO00116951
NCT ID
NCT06603844
Phase
I/II
Enrollment Status
Pending Open to Enrollment