This record was last updated January 23, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
The primary objective of Phase I of this trial is to evaluate the safety, tolerability, maximum tolerated dose (MTD)/maximum administered dose (MAD) of RC148 in patients with locally advanced unresectable or metastatic solid tumors to determine the recommended Phase II dose (RP2D), and the secondary objective is to evaluate the PK and PD characteristics, immunogenicity and preliminary clinical efficacy of RC148. Phase II will primarily evaluate the efficacy of the RC148 combination regimen, and secondarily will assess safety and tolerability, PK characteristics, and immunogenicity. During the trial, investigators will also evaluate the potential correlation of biomarkers with efficacy.
Protocol Amendment History
3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-08-24; most recent amendment 2025-01-21.
Status change: Not Yet Recruiting → Recruiting2023-11-24