Advanced Solid TumorPhase 1/2BiPAVE-001NCT06635785
Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
A Phase 1/2 study testing AI-081 in people with Advanced Solid Tumor, run by OncoC4, Inc. at 21 sites in United States.
Trial summary
BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- AI-081
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 21 sitesUnited States
- Study dates
- 26 Mar 2025to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kazu Kai, MD contact
21 sites in 1 country
United States21 sites, 21 recruiting
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
University of North Carolina at Chapel Hill Cancer Center
Chapel Hill, North Carolina, 27599
- Recruiting
Northwestern University
Chicago, Illinois, 60611
- Recruiting
The Ohio State University James Cancer Center
Columbus, Ohio, 43210
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
- Recruiting
Duke University Medical Center - Duke Cancer Center
Durham, North Carolina, 27710
- Recruiting
University of Florida UF Health Cancer Center
Gainesville, Florida, 32610
- Recruiting
Prisma Health
Greenville, South Carolina, 29605
- Recruiting
Memorial Healthcare System
Hollywood, Florida, 33021
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Norton Cancer Center
Louisville, Kentucky, 40202
- Recruiting
The Tisch Cancer Institute, Mount Sinai Medical Center
New York, New York, 10029
- Recruiting
Ocala Oncology Center PL DBA Florida Cancer Affiliates
Ocala, Florida, 34474
- Recruiting
AdventHealth Cancer Institute
Orlando, Florida, 32804
- Recruiting
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
- Recruiting
University of Texas Health San Antonio Mays Cancer Center
San Antonio, Texas, 78229
- Recruiting
Highlands Oncology Group
Springdale, Arkansas, 72762
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
- Recruiting
Novant Health Cancer Institute
Winston-Salem, North Carolina, 27103
About this study
BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors.
Read the detailed description
AI-081 is a bispecific antibody against PD-1 and VEGF. The study BiPAVE-001 is consisting of two integrated parts: Part A is the first-in-human dose escalation study to determine the recommended Phase 2 dose (RP2D) of AI-081 monotherapy, while Part B are dose optimization trials comparing the safety and clinical activities of AI-081 at RP2D and one dose level lower than RP2D (RP2D-1), either as monotherapy or in combination therapy with standard of care (SOC) in selected indications.
- Conditions
- Advanced Solid Tumor
- Being tested
- AI-081
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-081Drug
Also called Bispecific anti-PD-1/VEGF
AI-081 is a humanized monoclonal antibody targeting PD-1 and VEGF.
| Study group | Role | What they receive |
|---|---|---|
| AI-081 | Experimental | AI-081 will be given by IV infusion in designated dose, q3w. Receives: Drug: AI-081 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Maximal tolerable dose (MTD), the study drug, AI-081
Measured: 21 Days
Dose Limiting Toxicity (DLT)
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.
Measured: 21 Days
Secondary outcomes (2)
Cmax of AI-081
The highest Serum concentration of AI-081 after IV infusion at cycle 1 and cycle 3 from different timepoints (within 60 minutes before dosing, 60 minutes post-dose, 6 hours post-dose, 24 hours post dose, day 8, 15 and 21 post-dose) after drug administration.
Measured: 63 Days
The serum half-life of AI-081
To determine the drug concentration in serum samples that are taken in various timepoints (Cycle 1 and Cycle 3: within 60 minutes before dosing, 60 minutes post-dose, 6 hours post-dose, 24 hours post dose, day 8, 15 and 21 post-dose. Cycle 2 and Cycle 4-13: within 60 minutes before dosing and 60 minutes post-dose) during the treatment in order to calculate drug half life.
Measured: 63 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start26 Mar 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 387 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OncoC4, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kai He, MD, PhD, Principal investigator, The Ohio State University James Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635785
- Sponsor's protocol ID
- BiPAVE-001
- Acronym
- BiPAVE-001
- Status last verified
- Aug 2026
- First submitted
- 8 Oct 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06635785
- Acronym / sponsor ID
- BiPAVE-001 / BiPAVE-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 387 participants (estimated)
- Lead sponsor
- OncoC4, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors.
Detailed description
AI-081 is a bispecific antibody against PD-1 and VEGF. The study BiPAVE-001 is consisting of two integrated parts: Part A is the first-in-human dose escalation study to determine the recommended Phase 2 dose (RP2D) of AI-081 monotherapy, while Part B are dose optimization trials comparing the safety and clinical activities of AI-081 at RP2D and one dose level lower than RP2D (RP2D-1), either as monotherapy or in combination therapy with standard of care (SOC) in selected indications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AI-081 | Experimental | Drug: AI-081AI-081 will be given by IV infusion in designated dose, q3w. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-081Also: Bispecific anti-PD-1/VEGFAI-081 is a humanized monoclonal antibody targeting PD-1 and VEGF. | Drug | AI-081 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: 21 Days
Maximal tolerable dose (MTD), the study drug, AI-081
Dose Limiting Toxicity (DLT)
Time frame: 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.
2 secondary outcomes
Cmax of AI-081
Time frame: 63 Days
The serum half-life of AI-081
Time frame: 63 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kazu Kai, MD contact
Kai He, MD, PhD principal investigator
The Ohio State University James Cancer Center
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AI-081 in people with Advanced Solid Tumor, run by OncoC4, Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pan Zheng, MD, PhD (2027516823, pzheng@oncoc4.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: 21 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.