A Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
Phase 1
155
about 4.9 years
18+
11 sites in CO, CT, FL +3
What this study is about
Researchers are testing a treatment called YL211 in people with advanced solid tumors. The trial will evaluate how safe and well-tolerated YL211 is, as well as its effects on the body. Participants will receive YL211 intravenously until they meet criteria to stop treatment.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take YL211
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
intravenous
Primary: ORR assessed using RECIST version 1.1, To determine the MTD and select the recommended expansion dose(s) (RED(s)) of YL211 in patients with advanced solid tumors, To evaluate nature and frequency of AEs of YL211 in patients with advanced solid tumors according to NCI CTCAE version 5.0
Secondary: To characterize the AUC of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, To characterize the Cmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, To characterize the Tmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, To evaluate DCR of YL211 in patients with advanced solid tumors using RECIST version 1.1, To evaluate DoR of YL211 in patients with advanced solid tumors using RECIST version 1.1, To evaluate OS of YL211 in patients with advanced solid tumors using RECIST version 1.1, To evaluate PFS of YL211 in patients with advanced solid tumors using RECIST version 1.1