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NCT06635785 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
A Phase 1 study of Advanced Solid Tumor, sponsored by OncoC4.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 204
- Enrollment target
- 17
- Study locations
NCT06635785: Recruiting Phase 1 study of Advanced Solid Tumor, sponsored by OncoC4.
NCT06635785 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by OncoC4. The registered enrollment target is 204 participants, roughly in line with the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target. The trial reports 17 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06635785, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by OncoC4.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 204 participants
- Enrollment target
- 17
- Study locations
Study Summary
BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors.
Primary Outcome
Maximal tolerable dose (MTD), the study drug, AI-081
Conditions Studied
Interventions
- DRUG AI-081
Study Locations (17)
Florida
- University of Florida UF Health Cancer Center - Gainesville
- Memorial Healthcare System - Hollywood
- Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala
- AdventHealth Cancer Institute - Orlando
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
- Henry Ford Health - Detroit
North Carolina
- University of North Carolina at Chapel Hill Cancer Center - Chapel Hill
- Novant Health Cancer Institute - Winston-Salem
Alabama
- University of Alabama at Birmingham - Birmingham
Arkansas
- Highlands Oncology Group - Springdale
Illinois
- Northwestern University - Chicago
Kentucky
- Norton Cancer Center - Louisville
New York
- The Tisch Cancer Institute, Mount Sinai Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2025-03-26 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT06635785 shows while recruiting
NCT06635785 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target.
The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which AI-081 is the first listed.
NCT06635785 lists 17 locations in 12 states (Florida, Michigan, North Carolina).
Frequently Asked Questions
What is clinical trial NCT06635785 about?
NCT06635785 is a clinical study titled "Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors". BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors.
What is the current status of trial NCT06635785?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 204 participants. The study started on 2025-03-26. Estimated completion is 2027-12-31.
What conditions does trial NCT06635785 study?
This clinical trial studies the following conditions: Advanced Solid Tumor.
What interventions are being tested in trial NCT06635785?
The interventions under investigation include: AI-081 (DRUG).
Who is sponsoring clinical trial NCT06635785?
This trial is sponsored by OncoC4, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06635785 being conducted?
This trial has 17 study locations across Alabama, Arkansas, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06635785's enrollment target sits among peer trials
204 64th of 189 higher than 125 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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