Ozmosi | AI-061 Drug Profile
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AI-061

Alternative Names: AI-061, AI 061, AI061
Clinical Status: Active
Latest Update: 2026-04-09
Latest Update Note: Clinical Trial Update

Product Description

OncoC4 is developing AI-061. It 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. Both CTLA-4 and PD-1 are known targets for immunotherapy. (Sourced from: https://classic.clinicaltrials.gov/ct2/show/NCT05858736)

Mechanisms of Action: Unknown

Novel Mechanism: No

Modality: Antibody

Route of Administration: N/A

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Company: OncoC4
Company Location: Eastern America
Company Founding Year: 2020
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for AI-061

Countries in Clinic: Australia

Active Clinical Trial Count: 1

Recent & Upcoming Milestones

Highest Development Phases

Phase 1: Adenocarcinoma|Anus Cancer|Bile Duct Cancer|Bladder Cancer|Cervical Cancer|Colorectal Cancer|Endometrial Cancer|Esophageal Cancer|Fallopian Tube Cancer|Gastrointestinal Cancer|Head and Neck Cancer|Hepatocellular Carcinoma|Melanoma|Non-Small-Cell Lung Cancer|Peritoneal Cancer|Renal Cell Carcinoma|Squamous Cell Carcinoma|Uterine Cancer

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT05858736

PRESERVE-009

P1

Active, not recruiting

Colorectal Cancer|Esophageal Cancer|Fallopian Tube Cancer|Renal Cell Carcinoma|Squamous Cell Carcinoma|Non-Small-Cell Lung Cancer|Gastrointestinal Cancer|Endometrial Cancer|Bladder Cancer|Peritoneal Cancer|Bile Duct Cancer|Melanoma|Hepatocellular Carcinoma|Adenocarcinoma|Head and Neck Cancer|Cervical Cancer|Anus Cancer|Uterine Cancer

2026-07-31

50%

2026-04-10

Primary Completion Date|Primary Endpoints

Recent News Events

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Type

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