TQB3602 is a kind of proteasome inhibitor, AK105 is an anti-programmed cell death protein 1 (PD-1) antibody.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
TQB3602 is a kind of proteasome inhibitor, AK105 is an anti-PD-1 antibody.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Nong Yang
Changsha, Hunan, China
Dose Limiting Toxicity (DLT)
DLT will be assessed during the first 21 days of treatment for dose-escalation and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (21 days) of treatment.
Time frame: During the first 21 days
Maximum tolerated dose (MTD)
MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).
Time frame: During the first 21 days
Recommended phase II dose (RP2D)
The RP2D was the maximum tolerated dose (MTD) or less.
Time frame: Up to Cycle 28 (Cycle Length= 21 days)
Number of patients with adverse events (AEs) and serious adverse events (SAEs)
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: From the time of informed consent signed to 90 days after the last dose
Progression-free survival (PFS)
Defined as the time from the first dose of TQB3602 and AK105 to the first occurrence of disease progression or death from any cause.
Time frame: up to 2 years
Disease control rate (DCR)
Defined as the proportion of subjects with CR (Complete response), PR (Partial response), or SD (Stable Disease).
Time frame: up to 2 years
Duration of Response (DOR)
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Defined as the time from first documented response to documented disease progression.
Time frame: up to 2 years
Overall survival (OS)
OS is defined as the time between the date of first administration and the date of death due to any cause. A participant who has not died will be censored at the last known alive date.
Time frame: up to 5 years