NCT04452214

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

An Open-label, Safety and Tolerability Phase 1b Trial of CAN04, a Fully Humanized Anti-IL1RAP Monoclonal Antibody, and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Cantargia AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Urothelial Carcinoma
• Malignant Melanoma
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	CAN04	Administered intravenously
DRUG	Pembrolizumab	Administered intravenously
DRUG	Carboplatin	Administered intravenously
DRUG	Pemetrexed	Administered intravenously

Timeline

• Start date: 2020-09-24
• Primary completion: 2023-06-28
• Completion: 2023-06-28
• First posted: 2020-06-30
• Last updated: 2023-07-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study