The goal of this clinical trial is to assess the safety and tolerability of QLS1209 alone in patients with eligible advanced solid tumors,determine the maximum tolerated dose (MTD) or maximum drug dose(MAD)of QLS1209, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
149
Levels of QLS1209 will be explored in dose escalation, and determine the maximum tolerated dose.
Every 21 days is one cycle.1-3 dose levels of QLS1209 will be explored in dose optimization, and determine the recommended dose (RD) of QLS1209 and evaluate the preliminary anti-tumor activity of QLS1209.
AEs, TEAEs, TRAEs, SAEs
Incidence, severity and relevance to the trial drug of adverse events (AEs), treatment-related adverse events (TEAEs), treatment-related adverse events (TRAEs) and serious adverse events (SAEs)
Time frame: up to 2 years
MTD/MAD
maximum tolerated dose/ maximum drug dose
Time frame: Up to 21 days after the first dose
RP2D
recommended phase II dose
Time frame: Up to 21 days after the first dose
Tmax
Time to Reach Maximum (peak) Plasma Concentration Following Drug Administration
Time frame: up to 2 years
Cmax
Maximum Plasma Drug Concentration
Time frame: up to 2 years
ORR
Objective Response Rate
Time frame: up to 2 years
DoR
Duration of Response
Time frame: up to 2 years
DCR
Disease Control Rate
Time frame: up to 2 years
PFS
Progression-free Survival
Time frame: up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
OS
Overall Survival
Time frame: up to 2 years