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Tests treatment safety and results for Advanced Solid Tumor
Official title Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06635785
What this study is testing
What is AI-081?
AI-081 is an investigational medicine, being studied as a potential treatment for advanced solid tumor.
Also referred to as Bispecific anti-PD-1/VEGF.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Patients who have not recovered to NCI CTCAE grade ≤ 1 from an adverse event (AE) due to cancer therapeutics except the chemotherapy-associated...
- Patients who are currently enrolled in any other clinical trial testing an investigational agent or device, or with concurrent anticancer treatment...
- Patients who are on chronic systemic steroid therapy at doses higher than 10 mg/day prednisone or equivalent within 7 days before first treatment.
- Patients who have brain metastases or leptomeningeal metastases.
- Patient with a different cancer other than the one treated under this protocol, which requires systemic treatments within 24 months prior to C1D1.
- Patient has history of grade ≥3 allergic or hypersensitivity to IV infusion medications, or severe allergic reactions to food, pollen, oral...
See the full eligibility 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...
- Male patients, if sexually active, must agree to use adequate and effective methods of contraception starting with the first dose of study drug through 90 days after the last dose of study therapy.
- Patients who have not recovered to NCI CTCAE grade ≤ 1 from an adverse event (AE) due to cancer therapeutics except the chemotherapy-associated peripheral neuropathy (motor or sensory) or alopecia. Patients with ongoing...
- Patients who are currently enrolled in any other clinical trial testing an investigational agent or device, or with concurrent anticancer treatment (except palliative bone-directed radiotherapy), immune therapy, or...
- Patients who are on chronic systemic steroid therapy at doses higher than 10 mg/day prednisone or equivalent within 7 days before first treatment.
- Patients who have brain metastases or leptomeningeal metastases.
- Patient with a different cancer other than the one treated under this protocol, which requires systemic treatments within 24 months prior to C1D1.
- Patient has history of grade ≥3 allergic or hypersensitivity to IV infusion medications, or severe allergic reactions to food, pollen, oral medications, or atopic dermatitis or asthmatic episodes that required...
- Within past 6 months with history of significant cardiovascular acute myocardial infarction, acute coronary syndrome, ischemic or hemorrhagic stroke, revascularization procedures, acute pulmonary embolism or any...
- Patients who have acute infections which require systemic treatments within 14 days prior to C1D1.
- Patients who, in the opinion of the treating Investigator, have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the...
- Patients with known psychiatric or substance abuse disorders may interfere with cooperation with the requirements of the trial.
- Patients who are pregnant or breastfeeding or plan pregnancy or fathering the child during the study or within 6 months after the last dosing of study drug
- Patients with tumor surrounds important blood vessels or has obvious necrosis, cavitation, or invades surrounding important organs and blood vessels or otherwise with high risk of fatal hemorrhage
- Uncontrolled hypertension: systolic pressure ≥ 150 millimeters of mercury (mmHg) or diastolic pressure ≥ 90 mmHg on repeated measurements that cannot be managed by standard antihypertension medications ≤ 28 days before...
- Medical history of cardiovascular diseases, gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose.
- Patients with clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
- With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Springdale, Arkansas, United States
- Washington D.C., District of Columbia, United States
- Gainesville, Florida, United States
- Hollywood, Florida, United States
- Ocala, Florida, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Columbus, Ohio, United States
- Greenville, South Carolina, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Springdale, Arkansas, United States; Washington D.C., District of Columbia, United States; Gainesville, Florida, United States; Hollywood, Florida, United States; Ocala, Florida, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.