Study Details

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Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors

The main purpose of the study is to determine whether the experimental study drug, AI-081, is safe and well tolerated, and whether it is effective in treating advanced cancer that cannot be removed by surgery or has spread to a different part of the body (metastasis).

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

In the study, you will be screened for the study including a Computerized Tomography (CT) or MRI (magnetic resonance imaging) scan of your chest, abdomen (stomach area) and pelvis (hip area), and a head MRI to examine whether you have brain metastasis. You will have blood and urine tests done, and an optional tumor biopsy. During the study, you will have an infusion of the study drug AI-081 every three weeks and regular clinical exams, CT of MRI scans, blood and urine tests. There is also an optional tumor biopsy 8 weeks after the first treatment. You will meet with a member of the study team in addition to your oncology care team during your visits.

Incentives

$75 stipend per visit for all participants; For participants that live 25miles away from UNC reimbursement for mileage at a rate of $0.7 per mile and up to $250 per visit for hotel costs is available, The cost of the study drug, AI-081, will be covered by the study sponsor.

In-person visits:
Between 6- 38

Phone or online visits:
3

Total length of participation:
Between 5 months to three years of screening, treatment and discontinuation of study drug. Two years of survival follow-up.

Looking for Specific Volunteers

Able to participate:

You have a diagnosis of a solid tumor and metastatic disease or locally advanced disease that is not amenable to curative intent therapy.
You have a life expectancy should be greater or equal to 12 weeks.
You have adequate organ function as determined by laboratory tests

Not eligible if:

You are enrolled in any other clinical trial testing an investigational therapeutic agent or device
You have active symptomatic brain metastases
You are on chronic systemic steroid therapy at doses higher than 10 mg/day prednisone or equivalent within 7 days before first treatment
You have a different other than the one treated treated by this study, which required treatment in the 24 month before this study
Your tumor surrounds important blood vessels, invades surrounding important organs and blood vessels or otherwise with high risk of fatal hemorrhage.

Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors

Age & Gender

Visit Availability

Location

What will be asked of you

Incentives

Looking for Specific Volunteers

Able to participate:

Not eligible if:

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Additional Study Information

Principal Investigator

Study Type

Study Topics

IRB Number

ClinicalTrials.gov

Helpful Links

Questions?