A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20110 in Participants With Advanced Solid Tumors
Summary
This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20110 in participants with advanced solid malignant tumors
Arms & interventions
- DrugHS-20110 (Phase Ia:Dose escalation )
HS-20110 for IV infusion of various dose strengths administered in 21 day dosing cycles
- DrugHS-20110 (Phase Ib:Dose expansion )
The recommended dose from the dose-escalation stage and other potential doses will be further explored
Outcome measures
Primary
Maximum tolerated dose (MTD) or maximum applicable dose (MAD)
Time frame: From day 1 to one months after the last dose in Phase 1a
Objective response rate (ORR) as per RECIST v1.1
Time frame: From screening to 2 months after the last dose
Secondary
Incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose modification or permanent discontinuation, and specific laboratory abnormalities
Time frame: From the first dose until 90 days after the last dose
Objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and progression-free survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; overall survival (OS)
Time frame: From screening to up to 3 years after last dose
Incidence of anti-HS-20110 antibody (ADA)
Time frame: From the first dose until 90 days after the last dose
Drug concentrations of the three components of HS-20110 (including antibody-drug conjugates, total antibody, and payload)
Time frame: From the first dose until 90 days after the last dose
Eligibility criteria
Study locations (7)
BRCR Medical Center INC
Tamarac, Florida, 33321
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
NEXT Dallas
Irving, Texas, 75039
NEXT Oncology
San Antonio, Texas, 78229
NEXT Virginia
Fairfax, Virginia, 22031