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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 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.

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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.

Conditions Studied

Advanced Solid Tumor

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

FieldValue
Enrollment Target 204 participants
Start Date 2025-03-26
Est. Completion 2027-12-31
Phase Phase 1

Sponsor

OncoC4

7 total trials

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What the Registry Record Tells You About NCT06635785

The ClinicalTrials.gov registry entry for NCT06635785 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target. The listed sponsor is OncoC4, which has 7 total studies on file at ClinicalTrials.gov.

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 reports 17 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.