A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors
Phase 1
Completed
- Conditions
- Carcinoma, Non-Small-Cell LungUrothelial CarcinomaHead and Neck Squamous Cell CarcinomaMalignant Melanoma
- Interventions
- Registration Number
- NCT04452214
- Lead Sponsor
- Cantargia AB
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2) CAN04 Subjects will receive doses of CAN04 on Days 1 and 8 (Cycles 1 thru 4), and on Day 1 (Cycle 5 onwards) in combination with pembrolizumab given as standard regimen and carboplatin and pemetrexed standard of care CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2) Pemetrexed Subjects will receive doses of CAN04 on Days 1 and 8 (Cycles 1 thru 4), and on Day 1 (Cycle 5 onwards) in combination with pembrolizumab given as standard regimen and carboplatin and pemetrexed standard of care CAN04 and pembrolizumab (Part 1) CAN04 Subjects will receive weekly doses of CAN04 in combination with pembrolizumab given as standard regimen CAN04 and pembrolizumab (Part 1) Pembrolizumab Subjects will receive weekly doses of CAN04 in combination with pembrolizumab given as standard regimen CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2) Carboplatin Subjects will receive doses of CAN04 on Days 1 and 8 (Cycles 1 thru 4), and on Day 1 (Cycle 5 onwards) in combination with pembrolizumab given as standard regimen and carboplatin and pemetrexed standard of care CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2) Pembrolizumab Subjects will receive doses of CAN04 on Days 1 and 8 (Cycles 1 thru 4), and on Day 1 (Cycle 5 onwards) in combination with pembrolizumab given as standard regimen and carboplatin and pemetrexed standard of care
- Primary Outcome Measures
Name Time Method Percentage of subjects with grade ≥3 TEAEs (Part 1) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Percentage of subjects with grade ≥3 TEAEs (Part 2) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Frequency of TEAEs (treatment-emergent adverse events) (Part 1) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Frequency of TEAEs (treatment-emergent adverse events) (Part 2) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Number of participants with DLTs (dose-limiting toxicities) (Part 1) Up to day 28 Number of participants with DLTs (dose-limiting toxicities) (Part 2) Up to day 28 Number of subjects with grade ≥3 TEAEs (Part 1) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Number of subjects with grade ≥3 TEAEs (Part 2) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Number of subjects with 1 or more SAEs (serious adverse events) (Part 1) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Number of subjects with 1 or more SAEs (serious adverse events) (Part 2) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Percentage of subjects with 1 or more SAEs (Part 1) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Percentage of subjects with 1 or more SAEs (Part 2) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Number of subjects with 1 or more TEAEs leading to dose modifications (Part 1) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Number of subjects with 1 or more TEAEs leading to dose modifications (Part 2) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 1) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 2) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
- Secondary Outcome Measures
Name Time Method Serum concentrations of CAN04 and pembrolizumab (Part 1) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Serum concentrations of CAN04 and pembrolizumab (Part 2) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Antidrug antibodies (ADAs) against CAN04 From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Change in serum IL-6 (interleukin-6) concentration (Part 1) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Change in serum CRP (C-reactive protein) concentration (Part 1) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Progression free survival (Part 1) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Progression free survival (Part 2) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Overall survival (Part 1) Up to 36 months after 1st dose of last subject (or death) Overall survival (Part 2) Up to 36 months after 1st dose of last subject (or death) Change in serum IL-6 (interleukin-6) concentration (Part 2) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Change in serum CRP (C-reactive protein) concentration (Part 2) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Overall response rate (ORR) (Part 1) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Proportion of subjects with partial response (PR) or complete response (CR) to study treatment as defined by iRECIST (immune-related response evaluation criteria in solid tumors) and measured by radiological assessment (CT/MRI scan)
Overall response rate (ORR) (Part 2) From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first Proportion of subjects with partial response (PR) or complete response (CR) to study treatment as defined by iRECIST (immune-related response evaluation criteria in solid tumors) and measured by radiological assessment (CT/MRI scan)
Trial Locations
- Locations (3)
Florida Cancer Specialists & Research Institute
🇺🇸Lake Mary, Florida, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Hospital of The University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States