Drug intelligence / Profile preview

AI-061

Development stage
Phase 1
Lead developer
OncoC4
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

**AI-061** is an investigational 1:1 fixed-dose co-formulation of the anti-programmed cell death protein 1 antibody **AI-025** and the pH-sensitive anti-cytotoxic T-lymphocyte-associated protein 4 antibody **gotistobart**. It is designed to provide dual immune-checkpoint blockade, restoring T-cell activation and cytotoxic antitumor immunity by inhibiting PD-1- and CTLA-4-mediated suppressive signaling. OncoC4 is evaluating intravenous AI-061 in a Phase 1 dose-escalation study in advanced or metastatic solid tumors. ([cancer.gov](https://www.cancer.gov/publications/dictionaries/cancer-drug/def/813132))

Other names
AI-025/Gotistobart combination AI-061AI-025/ONC-392 anti-PD-1 antibody AI-025/anti-CTLA-4 antibody ONC-392 combination AI-061anti-PD-1 antibody AI-025/Gotistobart combination AI-061co-formulation AI-025/ONC-392 monoclonal antibodies combination formulation AI-061ONC-392/AI-025
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)

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