The primary purpose of this study is to examine the safety, tolerability and pharmacokinetics of PEG-ENDO in combination with docetaxel in subjects previously treated or untreated (standard therapy is not suitable or without standard therapy) for advanced or metatatic non-small cell lung cancer (NSCLC) or other solid tumors.
This is a multicenter, open-label, dose-escalation study in subjects with advanced or metatatic non-small cell lung cancer (NSCLC) or other solid tumors.There will be five cohorts planning as following: cohort 1: PEG-ENDO 1 mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 2: PEG-ENDO 2mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 3: PEG-ENDO 4 mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 4: PEG-ENDO 6 mg/kg+Docetaxel75 mg/m2,once every 3 weeks at day 1 cohort 5: PEG-ENDO 8 mg/kg+Docetaxel75 mg/m2, once every 3 weeks at day 1 \* Every 3 weeks as a treatment cycle. Subjects received only PEG-ENDO in the first cycle. For second cycle or the higher, they received a combination therapy of PEG-ENDO and docetaxel. Docetaxel was limited in 4 or 6 cycles。 The observation period of DLT was the 21 days after the first administration of PEG-ENDO. During the observation period of DLT (cycle 1), subjects only receive the corresponding dose of PEG-ENDO , for the second cycle and higher ,they will treated with the combination of PEG-ENDO and Docetaxel until disease progression (PD) or intolerance . Docetaxel was limited in 4 or 6 cycles。
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
PEG-ENDO 1 mg/kg or 2 mg/kg or 4 mg/kg or 6 mg/kg or 8 mg/kg+Docetaxel 75 mg/m2，once every 3 weeks at day 1
Beijing Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGTianjin medical university cancer institute&hospital
Tianjin, Tianjin Municipality, China
RECRUITINGDose Limiting Toxicities (DLT)
Incidence of Dose Limiting Toxicity
Time frame: First 21days for dosing（Cycle1，each cycle is 21 days)
Adverse Event(AE)
Incidence of Adverse Events
Time frame: From the time the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
Serious Adverse Event(SAE)
Incidence of Serious Adverse Events
Time frame: From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
Laborarory test abnormality
Incidence of clinically significant laboratory abnormalities
Time frame: From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
Vital signs abnormality
Incidence of vital signs abnormalities
Time frame: From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
Electrocardiogram(ECG) abnormality
Incidence of clinically significant ECG abnormalities
Time frame: From the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
Serum concentration
Serum concentration of PEG-ENDO
Time frame: Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.
The maximum (or peak) serum ,Cmax
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Cmax of PEG-ENDO following dose concentration.
Time frame: Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.
AUC
The area under the plot of serum concentration of drug (not logarithm of the concentration) against time after drug administration.
Time frame: Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.
other PK parameters
The other PK parameters (if applicable).
Time frame: Pharmacokinetics(PK) blood samples are collected at pre-dose, post-dose 0,1,4,8,24,48,96,168,336,480h of cycle1 and cycle5,respectively. And the pre-dose, post-dose 0h of other required cycles.
Maximum Tolerated Dose(MTD)
To determine the Maximum Tolerated Dose (MTD) of PEG-ENDO in subjects with Advanced / Metastatic NSCLC or Other Solid Tumors
Time frame: First 21days for dosing（Cycle1，each cycle is 21 days)
Overall Response Rate(ORR)
ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: at least 12 weeks
Duration of Response(DOR)
DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1
Time frame: Estimated at 4 months after fist documented PD or CR
Progression-free survival (PFS)
PFS is defined as time from date of first dose of study treatment to date of first documented disease progression or death due to any cause determined by by Investigator assessment in accordance to RECIST 1.1
Time frame: Estimated at 4 months.