Recruiting

BiPAVE-001AI-081 Bispecific Antibody for Advanced Solid Tumors

What is being tested

AI-081

Drug

Who is being recruted

Over 18 Years

+25 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: March 2025

See protocol details

Summary

Principal SponsorOncoC4, Inc.

Study ContactPan Zheng, MD, PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 26, 2025

Actual date on which the first participant was enrolled.

AI-081 is a new type of treatment being studied for people with advanced solid tumors. It targets two specific proteins, PD-1 and VEGF, which play roles in how tumors grow and evade the immune system. The study aims to find the most effective and safe dose of AI-081, either on its own or together with existing treatments, to improve outcomes for patients with these difficult-to-treat cancers. Understanding the right dose is crucial for maximizing benefits while minimizing potential side effects. Participants in this study will receive AI-081 in a controlled manner, with some receiving it alone and others in combination with standard cancer treatments. The study is organized in two parts: the first part focuses on identifying the safest dose for future studies, while the second part examines the effects of different doses. The research will closely monitor participants to ensure safety and to measure how well the treatment works against the tumors. This careful monitoring helps in understanding both the benefits and any risks associated with AI-081.

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

NCT06635785

Principal SponsorOncoC4, Inc.

Study ContactPan Zheng, MD, PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

204 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 inclusion criteria required to participate

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.

Show More Criteria

16 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 17 locations

Recruiting

University of Alabama at Birmingham

Birmingham, United StatesOpen University of Alabama at Birmingham in Google Maps

Recruiting

Highlands Oncology Group

Springdale, United States

Recruiting

University of Florida UF Health Cancer Center

Gainesville, United States

Recruiting

Memorial Healthcare System

Hollywood, United States

Recruiting

17 Study Centers