Recruiting
Phase 1
Phase 2

AI-081

Sponsor:

OncoC4, Inc.

Code:

NCT06635785

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AI-081

Study Details

Brief summary:

BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors.

Conditions

Advanced Solid Tumor

Study ID

NCT06635785

Start date

Mar 26, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

387 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AI-081

AI-081 will be given by IV infusion in designated dose, q3w.

Interventions

AI-081

AI-081 is a humanized monoclonal antibody targeting PD-1 and VEGF.

Primary outcome measure

  • Maximum tolerated dose (MTD) [ Time Frame: 21 Days ]
  • Dose Limiting Toxicity (DLT) [ Time Frame: 21 Days ]

Central Contacts and Locations

Central contacts

Pan Zheng, MD, PhD

2027516823pzheng@oncoc4.com

Kazu Kai, MD

kkai@oncoc4.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

MedStar Georgetown University Hospital

Recruiting

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

University of Florida UF Health Cancer Center

Recruiting

Gainesville, Florida, United States, 32610

Memorial Healthcare System

Recruiting

Hollywood, Florida, United States, 33021

Ocala Oncology Center PL DBA Florida Cancer Affiliates

Recruiting

Ocala, Florida, United States, 34474

AdventHealth Cancer Institute

Recruiting

Orlando, Florida, United States, 32804

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Norton Cancer Center

Recruiting

Louisville, Kentucky, United States, 40202

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

The Tisch Cancer Institute, Mount Sinai Medical Center

Recruiting

New York, New York, United States, 10029

University of North Carolina at Chapel Hill Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Duke University Medical Center - Duke Cancer Center

Recruiting

Durham, North Carolina, United States, 27710

Novant Health Cancer Institute

Recruiting

Winston-Salem, North Carolina, United States, 27103

The Ohio State University James Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Prisma Health

Recruiting

Greenville, South Carolina, United States, 29605

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

University of Texas Health San Antonio Mays Cancer Center

Recruiting

San Antonio, Texas, United States, 78229

University of Utah Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

More Information

Sponsor

OncoC4, Inc.

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by OncoC4, Inc. on 2026-08-17.