Actively Recruiting
Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
Led by OncoC4, Inc. · Updated on 2026-04-09
387
Participants Needed
19
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors.
CONDITIONS
Official Title
Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older at the time of signing informed consent
- Male or female; females of childbearing potential must have a negative pregnancy test
- Performance status of 0 or 1 on the ECOG Performance Scale
- Histological or cytological diagnosis of solid tumors with metastatic or locally advanced disease
- Measurable disease according to RECIST 1.1 criteria
- Adequate organ function based on laboratory values
- Voluntarily agreed to participate with written informed consent
- Female patients of childbearing potential and sexually active must agree to use effective birth control from first dose through 90 days after last dose
- Male patients who are sexually active must agree to use effective contraception from first dose through 90 days after last dose
You will not qualify if you...
- Not recovered to grade 1 or less from previous adverse events related to cancer treatment, except certain neuropathies or alopecia
- Currently enrolled in another clinical trial with investigational agents or receiving concurrent anticancer, immune, or cytokine therapy (except allowed palliative radiotherapy)
- On systemic steroid therapy above 10 mg/day prednisone equivalent within 7 days before first treatment
- Presence of brain or leptomeningeal metastases
- Having another cancer requiring systemic treatment within 24 months before first study dose
- History of severe allergic reactions to infusion medications, foods, or medications requiring hospitalization
- Recent history (within 6 months) of serious cardiovascular events or conditions resulting in reduced heart function
- Acute infections requiring systemic treatment within 14 days before first study dose
- Any condition or abnormality that could interfere with study participation or results, as judged by the investigator
- Known psychiatric or substance abuse disorders interfering with cooperation
- Pregnant or breastfeeding or planning pregnancy/fathering during study or within 6 months after last dose
- Tumors involving critical blood vessels or organs with high risk of fatal bleeding
- Uncontrolled hypertension despite medication
- History of cardiovascular disease, gastrointestinal perforation, or fistula within 6 months before first dose
- Symptomatic pleural, pericardial effusion, or ascites requiring frequent drainage
- History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases including diabetes, hypertension, pulmonary fibrosis, or acute lung diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
Actively Recruiting
3
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
4
University of Florida UF Health Cancer Center
Gainesville, Florida, United States, 32610
Actively Recruiting
5
Memorial Healthcare System
Hollywood, Florida, United States, 33021
Actively Recruiting
6
Ocala Oncology Center PL DBA Florida Cancer Affiliates
Ocala, Florida, United States, 34474
Actively Recruiting
7
AdventHealth Cancer Institute
Orlando, Florida, United States, 32804
Actively Recruiting
8
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
9
Norton Cancer Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
10
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
11
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
12
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
13
The Tisch Cancer Institute, Mount Sinai Medical Center
New York, New York, United States, 10029
Not Yet Recruiting
14
University of North Carolina at Chapel Hill Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
15
Novant Health Cancer Institute
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
16
The Ohio State University James Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
17
Prisma Health
Greenville, South Carolina, United States, 29605
Actively Recruiting
18
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
19
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
P
Pan Zheng, MD, PhD
CONTACT
K
Kazu Kai, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here