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New Dual-Action antibody takes on advanced cancers

NCT ID NCT06635785

Disease control Sponsor: OncoC4, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This study tests a new drug called AI-081 in people with advanced solid tumors that have spread or cannot be removed by surgery. The drug is a bispecific antibody that targets two proteins (PD-1 and VEGF) involved in cancer growth and immune evasion. The trial has two phases: first to find the safest dose, then to see how well it works. About 387 adults with measurable disease will participate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 387 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth Cancer Institute

    RECRUITING

    Orlando, Florida, 32804, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center - Duke Cancer Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Highlands Oncology Group

    RECRUITING

    Springdale, Arkansas, 72762, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • MedStar Georgetown University Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Memorial Healthcare System

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Norton Cancer Center

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Novant Health Cancer Institute

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Ocala Oncology Center PL DBA Florida Cancer Affiliates

    RECRUITING

    Ocala, Florida, 34474, United States

  • Prisma Health

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • The Ohio State University James Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The Tisch Cancer Institute, Mount Sinai Medical Center

    RECRUITING

    New York, New York, 10029, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Florida UF Health Cancer Center

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Michigan Rogel Cancer Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina at Chapel Hill Cancer Center

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Texas Health San Antonio Mays Cancer Center

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Utah Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.