The main objective of this clinical study is to evaluate the safety of XS005 injection; to determine the maximum tolerated dose . Furthermore, initial efficacy will be examined.
Treatment on this study includes eight XS005 infusions over an 16 week period. The study will evaluate the safety, feasibility and maximum tolerated dose (MTD) of XS005 using a 3+3 study design . The total study duration will be 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Treatment on this study includes XS005 infusions over an 16 week period. Phase 1: dose escalation (3+3); Phase 2 : dose of recommended phase 2 dose(RP2D).
Dushu Lake Hospital Affiliated to Soochow University
Suzhou, Jiangsu, China
Incidence of Dose-Limiting Toxicities (DLTs)
DLT is defined as a toxic effect in the subject at any dose, cannot be reasonably attributed to the subject's underlying disease, other conditions, and/or concomitants, that the investigator determines to be related (including definitely, likely, or possibly) to the XS005 injection.
Time frame: within 7 days after the the first infusion of XS005.
Incidence of Adverse Events (AEs)
AE is defined as any adverse medical event within 4 months after the the first infusion of XS005.
Time frame: 4 months
Maximum tolerated dose (MTD)
MTD is defined as the highest dose level of less than or equal to 2 DLT among the 6 subjects finally determined.
Time frame: within 7 days after the the first infusion of XS005.
Progression-free survival (PFS)
PFS : defined as the time from the start of treatment until the onset of tumor progression or death from any cause;
Time frame: From the start of treatment until the time of first disease progression or death , assessed up to 12 months post-treatment
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