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

Study acronym: PRESERVE-009
StatusCompleted
PhasePhase 1
Started

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Record History

  1. Trial completedv6
  2. Primary and study completion dates pushed to Jul 31, 2026v5
  3. Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 15, 2025 to Jun 15, 2026
    • Site details revised at 5 of 5 sites
    v4
  4. Site details revised at 1 of 5 sitesv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 4 to 5
    • Start date changed from estimate of Jun 15, 2023 to Jul 11, 2023
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
OncoC4, Inc.
9 trials monitored
See 2 trials at risk
Lung Cancer
4,822 trials monitored
See 267 trials at risk
Colorectal Cancer
3,420 trials monitored
See 162 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,101 trials monitored
See 174 trials at risk
and 11 more diseases
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).
Trial Details
NCT Number NCT05858736
Lead Sponsor OncoC4, Inc.
Collaborators: OncoC4 AU Pty Ltd, Avance Clinical Pty Ltd.
Conditions
(from sponsor)		 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
Related terms Anus Neoplasms, Bile Duct Neoplasms, Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Colorectal Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Fallopian Tube Neoplasms, Melanoma, Squamous Cell Carcinoma of Head and Neck, Stomach Neoplasms, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov