The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab deruxtecan(T-DXd) over a range of advanced and/or metastatic solid tumors.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Incidence and nature of Dose-Limiting Toxicity (DLTs) (dose escalation phase of Part A and B)
Timeframe: Study Day 1, assessed up to DLT period (3 weeks after treatment)
Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs) (dose escalation phase of Part A and B)
Timeframe: Study Day 1, assessed up to approximately 24 months
Objective Response Rate (ORR) (dose optimization phase of Part A, dose expansion phase of Part B, Part C and D)
Timeframe: Study Day 1, assessed up to approximately 24 months