At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients With Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating CAN016 for Patients With Advanced Solid Tumors. Not yet recruiting, targeting 90 participants across 1 site.
Detailed Summary
A Phase I/II, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients with Advanced Solid Tumors
Study Details
Timeline
Arms & Interventions
CAN016
CAN016
CAN016
CAN016
Interventions
CAN016 will be administered intravenously into each patient on Day 1 of Cycle 1. Patients will continue to receive CAN016 Q3W until unacceptable toxicity, progressive disease, or withdrawal of consent, death, lost to F/U, or other discontinuation criteria is met.
an initial dose of CAN016 0.75 mg/kg will be administered intravenously into each patient for approximately 90 minutes on Day 1 of Cycle 1. A 21-day observation period (Cycle 1) will then occur as DLT period, at the end of which all relevant safety data will be reviewed. Upon completion of cycle 1, patients will continue to receive CAN016 once every 3 weeks (Q3W, unless the pharmacokinetic data suggests a different schedule of administration) until unacceptable toxicity, progressive disease (PD), or withdrawal of consent, death, lost to follow-up (F/U), or other discontinuation criteria is met