The purpose of this study is to evaluate the safety,tolerability, pharmacokinetics, and preliminary efficacy of KC1036 in participants with advanced recurrent or metastatic solid tumors. The trial will be divided into three parts: dose-escalation phase, dose-expansion phase, RP2D-extension phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
207
Part 1: Dose-escalation phase , KC1036 10mg\~80mg, consists of 5 Cohorts. Part 2: Dose-expansion phase, consists of 3\~4 Cohorts based on part 1. Part 3:RP2D-extension phase, Recommended dose of KC1036 based on part 1and part 2.
ChongQing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGThe First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
RECRUITINGWest China Hospital
Chengdu, Sichuan, China
RECRUITINGMaximum tolerated dose (MTD)
MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing.
Time frame: First 4 weeks after initial administration of KC1036
Adverse events (AEs)
Incidence of treatment-related AEs
Time frame: From enrollment up to 30 days after last dose
Pharmacokinetics (PK) profile: Cmax
Peak Plasma Concentration
Time frame: First 4 weeks after initial administration of KC1036
Pharmacokinetics (PK) profile: Tmax
Time to reach the maximum plasma concentration
Time frame: First 4 weeks after initial administration of KC1036
Pharmacokinetics (PK) profile: T1/2
Terminal half-life
Time frame: First 4 weeks after initial administration of KC1036
Pharmacokinetics (PK) profile: AUC0-t and AUC0-∞
Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration, or Area under the single-dose plasma concentration-time curve from Hour 0 to infinity
Time frame: First 4 weeks after initial administration of KC1036
Objective Response Rate (ORR)
Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.1.
Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Progression-free survival (PFS)
Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.1 or death due to any cause.
Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) was defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.
Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months
Duration of Response (DOR)
Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.1.
Time frame: Every 6 weeks for the duration of study participation; estimated to be 12 months
Overall Survival (OS)
Overall Survival (OS) was defined as the time from the start date of study drug to the date of death due to any cause.
Time frame: From the first medication to death due to any cause; estimated to be the subject's death, loss to follow-up, or end of the study]