Clinical Trial

Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors

Study acronym: PRESERVE-009
Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated April 9, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
AI-061 is a co-formulation drug product (DP) consisting of 1:1 ratio mix of AI-025, an anti-PD-1 antibody, and ONC-392, an anti-CTLA-4 antibody. This is a dose escalation study to identify the maximum toxicity dose (MTD) or the recommended phase 2 dose (RP2D).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-05-12; most recent amendment 2026-04-08.
Status change: Recruiting → Active, Not Recruiting 2025-01-30
Status change: Not Yet Recruiting → Recruiting 2023-07-11
Trial Details
NCT Number NCT05858736
Lead Sponsor OncoC4, Inc.
Collaborators: OncoC4 AU Pty Ltd, Avance Clinical Pty Ltd.
Conditions Melanoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, High Grade Serous Adenocarcinoma of Ovary, Primary Peritoneal Carcinoma, Fallopian Tube Cancer, Endometrial Cancer, Cervical Cancer +9 more
Enrollment 18 participants
Start Date 2023-07-11
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-09