Purpose of this Study
We are doing this study to find the safest and most effective dose of a study drug called PRO1160 in patients with metastatic kidney cancer.
Who Can Participate?
Eligibility
Adults with advanced or metastatic kidney cancer who have already received at least 1 prior treatment combination that contains the following:<ul>
<li>At least 1 prior oral therapy (TKI)</li>
<li>At least 1 immunotherapy (IO)</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: kellie.shobe@duke.edu">kellie.shobe@duke.edu.</a>
<li>At least 1 prior oral therapy (TKI)</li>
<li>At least 1 immunotherapy (IO)</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: kellie.shobe@duke.edu">kellie.shobe@duke.edu.</a>
What is Involved?
The study is divided into three periods: a screening period, a study dosing period, and a follow-up period.
If you choose to join the study, you will go through a screening period which lasts about 4 weeks. During this period, you will:<ul>
<li>Agree to send a tumor tissue sample for genetic testing</li>
<li>Get a CT and bone scan</li>
<li>Have blood and urine tests, EKGs, and physical exams</li></ul>
If you are eligible based on screening, you will proceed to the study dosing period. During this period of the study, you will:<ul>
<li>Receive the study drug by IV every 3 weeks</li>
<li>Have visits every 3 weeks</li></ul>
At various visits, you will have blood and urine tests, EKGs, physical exams, and CT and bone scans.
When the dosing period ends, you will proceed to the follow-up period. During this period of the study, you will:<ul>
<li>Have a safety visit 30 days after your last dose of the study drug (in some cases, this may be done by phone)</li>
<li>Have long-term follow-up phone calls every 3 months for up to 1 year</li>
<li>In some cases, you may also need follow-up CT and bone scans every 3 months</li></ul>
If you choose to join the study, you will go through a screening period which lasts about 4 weeks. During this period, you will:<ul>
<li>Agree to send a tumor tissue sample for genetic testing</li>
<li>Get a CT and bone scan</li>
<li>Have blood and urine tests, EKGs, and physical exams</li></ul>
If you are eligible based on screening, you will proceed to the study dosing period. During this period of the study, you will:<ul>
<li>Receive the study drug by IV every 3 weeks</li>
<li>Have visits every 3 weeks</li></ul>
At various visits, you will have blood and urine tests, EKGs, physical exams, and CT and bone scans.
When the dosing period ends, you will proceed to the follow-up period. During this period of the study, you will:<ul>
<li>Have a safety visit 30 days after your last dose of the study drug (in some cases, this may be done by phone)</li>
<li>Have long-term follow-up phone calls every 3 months for up to 1 year</li>
<li>In some cases, you may also need follow-up CT and bone scans every 3 months</li></ul>
Study Details
Full Title
Phase 1/2 Study of PRO1160 in Patients with Metastatic Renal Cell Carcinoma (RCC), Metastatic or Relapsed Nasopharyngeal Carcinoma (NPC), or Advanced (Stage III or IV) Non-Hodgkin Lymphoma (NHL)
Principal Investigator
Michael
Harrison
Protocol Number
PRO00114305
NCT ID
NCT05721222
Phase
I/II
Enrollment Status
Pending Open to Enrollment