NCT05858736

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

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: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: OncoC4, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

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
• Renal Cell Carcinoma
• Bladder Cancer
• Esophageal Cancer
• Gastric Cancer
• Gastroesophageal-junction Cancer
• Colorectal Cancer
• Anal Cancer
• Hepatocellular Carcinoma
• Bile Duct Cancer

Interventions

Type	Name	Description
DRUG	AI-061	A 1:1 Co-formulation of AI-025 (Anti-PD-1) and ONC- 392 (Anti-CTLA-4) Antibodies.

Timeline

• Start date: 2023-07-11
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2023-05-15
• Last updated: 2026-04-09

Locations

5 sites across 1 country: Australia