Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
NCT ID: NCT06635785
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
204 participants
INTERVENTIONAL
2025-03-26
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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AI-081
AI-081 will be given by IV infusion in designated dose, q3w.
AI-081
AI-081 is a humanized monoclonal antibody targeting PD-1 and VEGF.
Interventions
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AI-081
AI-081 is a humanized monoclonal antibody targeting PD-1 and VEGF.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 first dose of study drug through 90 days after the last dose of study therapy.
Exclusion Criteria
* 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 cytokine therapy or anticipated to require another antineoplastic therapy during the study.
* 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 hospitalization.
* 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 disorders resulted in LVEF \< 40% at the time of screening or colitis, small bowel obstruction, hepatitis or pancreatitis adrenal insufficiency, or severe immunotherapy related AE (irAE≥ grade 3).
* 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 patient's participation for the full duration of the study, or make study participation not in the best interest of the patient, in the opinion of the treating Investigator. Investigators should discuss the case with the Sponsor and/or study leaders.
* 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 the first dose of study drug(s).
* 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.
18 Years
ALL
No
Sponsors
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OncoC4, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kai He, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Ohio State University James Cancer Center
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Highlands Oncology Group
Springdale, Arkansas, United States
University of Florida UF Health Cancer Center
Gainesville, Florida, United States
Memorial Healthcare System
Hollywood, Florida, United States
Ocala Oncology Center PL DBA Florida Cancer Affiliates
Ocala, Florida, United States
AdventHealth Cancer Institute
Orlando, Florida, United States
Northwestern University
Chicago, Illinois, United States
Norton Cancer Center
Louisville, Kentucky, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Henry Ford Health
Detroit, Michigan, United States
The Tisch Cancer Institute, Mount Sinai Medical Center
New York, New York, United States
University of North Carolina at Chapel Hill Cancer Center
Chapel Hill, North Carolina, United States
Novant Health Cancer Institute
Winston-Salem, North Carolina, United States
The Ohio State University James Cancer Center
Columbus, Ohio, United States
Prisma Health
Greenville, South Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Mijail Zambrano
Role: primary
Amnazo Muhirwa
Role: primary
Monika Ghorpade
Role: backup
Other Identifiers
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BiPAVE-001
Identifier Type: -
Identifier Source: org_study_id