Back to search results

AI-081 for Advanced Solid Tumors

This study is testing a new treatment called AI-081 for people with advanced solid tumors. AI-081 is a special type of antibody that targets two specific proteins, PD-1 and VEGF, which can help tumors grow. The main goals are to find the safest dose of AI-081 and see how well it works. You might be able to join if you are at least 18 years old, have a solid tumor that has spread or is advanced, and meet other health requirements. The study is currently recruiting up to 387 participants.

Study design
This is an interventional study with an estimated enrollment of 387 participants. It has two parts: Part A to find the best dose of AI-081 alone, and Part B to compare AI-081 alone or with standard treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary safety endpoints, Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT), are measured at 21 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06635785

Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
OncoC4, Inc.
~387 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:AI-081

At a glance

Recruiting sites
21 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD)
Measured over 21 Days
+1 more outcome measured

Conditions

Advanced Solid Tumor

Explore related trials

Solid Neoplasm

NCT06635785

Where you'd take part

This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AdventHealth Cancer Institute

    Orlando, Floridano site contact published

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusettsno site contact published

    Recruiting

  • Duke University Medical Center - Duke Cancer Center

    Durham, North Carolinano site contact published

    Recruiting

  • Henry Ford Health

    Detroit, Michiganno site contact published

    Recruiting

  • Highlands Oncology Group

    Springdale, Arkansasno site contact published

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasno site contact published

    Recruiting

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbiano site contact published

    Recruiting

  • Memorial Healthcare System

    Hollywood, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kai He, MD, PhD · PRINCIPAL_INVESTIGATOR · The Ohio State University James Cancer Center

Who to contact

Pan Zheng, MD, PhD
[email protected]
2027516823
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Maximum tolerated dose (MTD)21 Days

    Maximal tolerable dose (MTD), the study drug, AI-081

  • Dose Limiting Toxicity (DLT)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.