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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
OncoC4, Inc.
Study ID
NCT06635785
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors.

Key Dates

Start date
Mar 26, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
387 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: 21 Days ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
Highlands Oncology GroupSpringdaleArkansas72762-
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007-
University of Florida UF Health Cancer CenterGainesvilleFlorida32610-
Memorial Healthcare SystemHollywoodFlorida33021-
Ocala Oncology Center PL DBA Florida Cancer AffiliatesOcalaFlorida34474-
AdventHealth Cancer InstituteOrlandoFlorida32804-
Northwestern UniversityChicagoIllinois60611-
Norton Cancer CenterLouisvilleKentucky40202-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-
Henry Ford HealthDetroitMichigan48202-
The Tisch Cancer Institute, Mount Sinai Medical CenterNew YorkNew York10029-
University of North Carolina at Chapel Hill Cancer CenterChapel HillNorth Carolina27599-
Novant Health Cancer InstituteWinston-SalemNorth Carolina27103-
The Ohio State University James Cancer CenterColumbusOhio43210-
Prisma HealthGreenvilleSouth Carolina29605-
MD Anderson Cancer CenterHoustonTexas77030-
University of Utah Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALHighlands Oncology Group· Springdale, ARMedStar Georgetown University Hospital· Washington D.C., DCUniversity of Florida UF Health Cancer Center· Gainesville, FLMemorial Healthcare System· Hollywood, FLOcala Oncology Center PL DBA Florida Cancer Affiliates· Ocala, FL

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