Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors — PRESERVE-009  

Colorectal Cancer Clinical Trial

Official title: Safety, Pharmacokinetics (PK) and Efficacy of AI-061, A 1:1 Co-formulation of AI-025 (Anti-PD-1) and ONC-392 (Anti-CTLA-4) Antibodies in Advanced Solid Tumors: An Open-Label Phase 1 Study

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

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. Both CTLA-4 and PD-1 are known targets for immunotherapy. This Phase I study will test 3 fixed doses of AI-061 given as intravenous (IV) infusion, once every 21 days (q3w): 200 mg (consists of 100 mg ONC-392 and 100 mg AI-025), 400 mg and 600 mg. The target population is patient with advanced or metastatic solid tumors that progressed on standard care systemic therapy or intolerable to standard of care systemic therapy. The primary objective is to determine the maximum toxicity dose (MTD) or the Recommended Phase 2 dose (RP2D). The study design follows the classical 3+3 design for Phase 1 study that will enroll up to 18 subjects. The treatment will be terminated when patient has intolerable toxicity, or death, or disease progression, or complete of 17 cycles of treatment in approximate 1 year, whichever come first. ;

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Bile Duct Cancer
• Bile Duct Neoplasms
• Bladder Cancer
• Carcinoma
• Cervical Cancer
• Colorectal Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Esophageal Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Gastric Cancer
• Gastroesophageal-junction Cancer
• Head and Neck Squamous Cell Carcinoma
• Hepatocellular Carcinoma
• Melanoma
• Non Small Cell Lung Cancer
• Primary Peritoneal Carcinoma
• Renal Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

• NCT number: NCT05858736
• Study type: Interventional
• Source: OncoC4, Inc.
• Contact: Pan Zheng, MD, PhD
• Phone: 2027516823
• Email: pzheng@oncoc4.com
• Status: Recruiting
• Phase: Phase 1
• Start date: July 11, 2023
• Completion date: June 15, 2025