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

NCT06635785 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2026-04-09

No results posted yet for this study

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

Interventions

DRUG

AI-081

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

Sponsors & Collaborators

  • OncoC4, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-26
Primary Completion
2027-06-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06635785 on ClinicalTrials.gov