Purpose of this Study
This study includes several groups of patients with different types of cancer. Each group tests a new medicine called AI 081 at different dose levels. In some groups, people are placed into two groups by chance to receive different doses to find the best amount of the medicine. In other groups, the medicine is given along with standard chemotherapy. There is also a group where everyone receives the same dose of the medicine. The goal is to learn which dose is safest and works best for different types of cancer.
Who Can Participate?
Eligibility
People can join this study if they are 18 years or older, weigh at least 40 kilograms, and have cancer that has spread or cannot be treated with surgery. They must be healthy enough overall, with organs working well, and have a tumor that can be measured on scans. They should have a life expectancy of at least three months.
People cannot join if they are still having strong side effects from past cancer treatments, are currently in another treatment study, or are receiving other cancer treatments at the same time. They also cannot join if they have certain types of lung cancer, need high doses of steroid medicines, or have active cancer in the brain that is causing symptoms. People with recent treatment for another cancer or with a history of severe allergic reactions to certain medicines may also not be able to join.
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?
Description
This part of the study looks at how a new medicine called AI 081 works for different types of cancer. These include colorectal cancer, lung cancer, and a rare cancer called angiosarcoma. The study tests the medicine by itself or together with chemotherapy. Researchers want to see if the medicine is safe and if it can help treat these cancers.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
Principal Investigator
Niharika
Mettu
Protocol Number
PRO00119499
NCT ID
NCT06635785
Phase
I
Enrollment Status
Open to Enrollment