A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors

Summary

This study will consider the safety and effectiveness of a study drug, CAN04, in combination with pembrolizumab, in the treatment of incurable or metastatic non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma, urothelial cancer, or malignant melanoma. The study aims to establish a recommended dose of CAN04 in combination with the standard dose of pembrolizumab (Part 1), and in combination with pembrolizumab standard dose, and Standard of Care carboplatin and pemetrexed (Part 2 - subjects with stage IV, non-squamous metastatic NSCLC). CAN04, pembrolizumab. carboplatin and pemetrexed will be administered intravenously.

Timeline

Start

2020-09-24

Primary completion

2023-06-28

Completion

2023-06-28

Publications

• Cohen RB, Jimeno A, Hreno J, Sun L, Wallen-Ohman M, Millrud CR, Sanfridson A, Garcia-Ribas I. Safety, tolerability, and preliminary efficacy of nadunolimab, an anti-IL- 1 receptor accessory protein monoclonal antibody, in combination with pembrolizumab in patients with solid tumors. Invest New Drugs. 2025 Jun;43(3):609-620. doi: 10.1007/s10637-025-01538-3. Epub 2025 May 1.

Drugs

Indications