A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors
NCT04452214 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2023-07-14
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
- DRUG
-
CAN04
Administered intravenously
- DRUG
-
Administered intravenously
- DRUG
-
Administered intravenously
- DRUG
-
Pemetrexed
Administered intravenously
Sponsors & Collaborators
-
Cantargia AB
lead INDUSTRY
Principal Investigators
-
Ignacio Garcia-Ribas, MD, PhD · Cantargia AB
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-24
- Primary Completion
- 2023-06-28
- Completion
- 2023-06-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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