NCT06635785 · OncoC4, Inc.
Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
(BiPAVE-001)
What this study is about
BIPAVE-001 is a Phase 1-2 study for evaluating the safety, how the drug moves through the body (PK), and effectiveness of AI-081 in solid tumors.
View original scientific description
BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors.
Interventions
DRUG
AI-081
AI-081 is a humanized monoclonal antibody targeting PD-1 and VEGF.
Primary outcome measures
Maximum tolerated dose (MTD)
Time frame: 21 Days
Maximal tolerable dose (MTD), the study drug, AI-081
Dose Limiting Toxicity (DLT)
Time frame: 21 Days
The number of subjects who have Dose limiting toxicity (DLT) as defined by protocol DLT criteria during the first cycle of study drug, AI-081, administration.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient is ≥ 18 years of age on the day of signing informed consent.
- Male or female, female patient of childbearing potential must have negative pregnancy test.
- Patient must have a performance status of ≤ 1 on the ECOG Performance Scale.
- Patients must have a histological or cytological diagnosis of solid tumors and have metastatic disease or locally advanced disease.
- Measurable disease as determined by RECIST 1.1
- Patient must have adequate organ function as indicated by the following laboratory values
- Patient has voluntarily agreed to participate by giving written informed consent.
- Female patients enrolled in the study, if having childbearing potential (WOCBP) and sexually active, must agree to use adequate and effective birth control starting with the first dose of study drug through 90 days after the last dose of study therapy.
- Male patients, if sexually active, must agree to use adequate and effective methods of contraception starting with the
Where
- Birmingham, Alabama
- Springdale, Arkansas
- Washington D.C., District of Columbia
- Gainesville, Florida
- Hollywood, Florida
- Ocala, Florida
- Orlando, Florida
- Chicago, Illinois
- Louisville, Kentucky
- Boston, Massachusetts
- Ann Arbor, Michigan
- Detroit, Michigan
And 7 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations