Clinical Trial: NCT05858736
Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | OncoC4, Inc. |
| Information Provided By: | OncoC4, Inc. |
| Last Update Posted: | 2026-09-14 |
Study Overview
Brief 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).
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
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
Intervention / Treatment
- Drug: AI-061
Other Study ID Numbers
- AI-061-AU-01
Start Date (Actual)
2023-07-11
Primary Completion Date (Actual)
2026-07-31
Study Completion Date (Actual)
2026-07-31
Enrollment (Actual)
18
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | OncoC4, Inc. |
| Information Provided By: | OncoC4, Inc. |
| Last Update Posted: | 2026-09-14 |
Study Overview
Brief 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).
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
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
Intervention / Treatment
- Drug: AI-061
Other Study ID Numbers
- AI-061-AU-01
Start Date (Actual)
2023-07-11
Primary Completion Date (Actual)
2026-07-31
Study Completion Date (Actual)
2026-07-31
Enrollment (Actual)
18
Study Type
Interventional
Phase
Phase 1