This is a phase I/II non-randomized, open-label, single-arm, multicenter study to evaluate the Safety and Efficacy of C019199 Plus Sintilimab in Participants With Advanced Solid Tumors.
Phase I will determine and confirm the maximum tolerated dose(MTD) and recommended phase II dose(RP2D) for C019199 in combination with 200 milligrams (mg) ( intravenous\[IV\], every 3 weeks \[Q3W\]) Sintilimab in patients with advanced Solid tumors. Phase II will evaluate the safety and efficacy of the combination of C019199 and Sintilimab in selected solid tumors at the RP2D from Phase I.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
155
The C019199 will be taken orally, once a day
Sintilimab will be administrated with intravenous infusion, 200mg, every 3 weeks.
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Hunan Cancer Hospital
Changsha, Hunan, China
Dose-Limiting Toxicity (DLT)
Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.
Time frame: Cycle 1 (Cycle length=21 days)
Objective Response Rate (ORR) Based on iRECIST
ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) for target and non-target lesions.
Time frame: From date of enrollment until the date of first documented progression or death
Progression-free Survival (PFS) after administration
Progression-free Survival (PFS) is defined as the time from the date of first dose of the study drug to the first documented disease progression (according to iRECIST ) or death (due to any cause), whichever occurs first.
Time frame: From date of enrollment until the date of first documented progression or death
Number of Participants With Treatment-emergent Adverse Events( TEAEs )and Serious Adverse Events (SAEs)
A TEAE was defined as an adverse event (AE) that emerged during the time from the first dose of study drug to 28 days following the last dose of study drug,which does not necessarily have a causal relationship with the treatment. A Serious AE is any untoward medical occurrence that at any dose: resulted in death; was life threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria
Time frame: From the first dose until 28 days after the last dose
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Cmax
Maximum Plasma Concentration
Time frame: Cycle 1 Day 1; Cycle 1 Day 21
AUC(0-t):
Area under the concentration-time curve (AUC)
Time frame: Cycle 1 Day 1; Cycle 1 Day 21
T1/2
Terminal Half-life
Time frame: Cycle 1 Day 1; Cycle 1 Day 21
Disease Control Rate (DCR) after administration
Disease Control Rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease.
Time frame: From date of enrollment until the date of first documented progression or death
Duration of Remission (DoR) after administration
Duration of Remission (DoR) is defined as the time from the first documentation of remission (PR or better) to the first documented disease progression evidence (according to iRECIST ) of the responders (who achieve PR or better response).se).
Time frame: From date of enrollment until the date of first documented progression or death
Overall Survival (OS) after administration
OS is defined as the time from the date of study treatment to the date of death due to any cause .
Time frame: The time from the date of enrollment until death