NCT06635785

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 387 (estimated)
• Sponsor: OncoC4, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	AI-081	AI-081 is a humanized monoclonal antibody targeting PD-1 and VEGF.

Timeline

• Start date: 2025-03-26
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2024-10-10
• Last updated: 2026-04-09

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study