Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
OncoC4, Inc.
Summary
BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 wr…
Interventions
- DrugAI-081
AI-081 is a humanized monoclonal antibody targeting PD-1 and VEGF.
Locations (19)
- University of Alabama at BirminghamBirmingham, Alabama
- Highlands Oncology GroupSpringdale, Arkansas
- MedStar Georgetown University HospitalWashington D.C., District of Columbia
- University of Florida UF Health Cancer CenterGainesville, Florida
- Memorial Healthcare SystemHollywood, Florida
- Ocala Oncology Center PL DBA Florida Cancer AffiliatesOcala, Florida