Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
Launched by ONCOC4, INC. · Oct 8, 2024
Trial Information
Current as of July 26, 2025
Recruiting
Keywords
ClinConnect Summary
The clinical trial titled "BIPAVE-001" is studying a new treatment called AI-081, which is a special type of antibody designed to target certain proteins in advanced solid tumors. This trial is currently in Phase 1-2, meaning it's one of the early steps in testing the safety and effectiveness of the treatment. If you have advanced solid tumors that are either metastatic (spread to other parts of the body) or locally advanced, you may be eligible to participate. To join, you need to be at least 18 years old, have a measurable disease as confirmed by medical tests, and agree to use contraception if you're capable of becoming pregnant.
Participants in this trial can expect to receive the experimental treatment while being closely monitored for any side effects and how well it works. The researchers aim to gather important information on the safety and how the body processes the drug. It's essential to know that there are some specific criteria for participation, such as not being involved in other clinical trials or having certain health conditions that could complicate your participation. If you're interested in learning more, it would be best to discuss this with your healthcare provider to see if this trial is a good fit for you.
Gender
ALL
Eligibility criteria
- 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 first dose of study drug through 90 days after the last dose of study therapy.
- Exclusion Criteria:
- • 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 and adequately controlled endocrine immune-related AEs are considered stable and eligible for enrollment. The washout period for treatment regimen containing monoclonal antibodies is 28 days. Palliative radiotherapy for painful metastases or metastases in potentially sensitive locations (e.g., epidural space) ≥ 7 days prior to the first dose of study drug. Best supportive care, such as thyroxine, insulin, steroid replacement treatment, blood transfusion and therapy for non-cancer condition are allowed.
- • 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.
About Oncoc4, Inc.
OncoC4, Inc. is a biopharmaceutical company focused on the development of innovative immunotherapies for the treatment of cancer. Leveraging cutting-edge research and advanced scientific expertise, OncoC4 aims to harness the body’s immune system to combat various malignancies. The company is committed to advancing its proprietary therapeutic candidates through rigorous clinical trials, with the goal of improving patient outcomes and expanding treatment options for those affected by cancer. With a dedicated team of professionals and a robust pipeline, OncoC4 is poised to make significant contributions to the field of oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
New York, New York, United States
Houston, Texas, United States
Birmingham, Alabama, United States
Hollywood, Florida, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Greenville, South Carolina, United States
Ann Arbor, Michigan, United States
Springdale, Arkansas, United States
Orlando, Florida, United States
Louisville, Kentucky, United States
Columbus, Ohio, United States
Ocala, Florida, United States
Detroit, Michigan, United States
Gainesville, Florida, United States
Ann Arbor, Michigan, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Pittsburgh, Pennsylvania, United States
Patients applied
Trial Officials
Kai He, MD, PhD
Principal Investigator
The Ohio State University James Cancer Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported