This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC006 in patients with a variety of solid tumors, including small cell lung cancer, multiple myeloma, and neuroblastoma, and hematological malignancies.
This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC006 in patients with a variety of solid tumors, including small cell lung cancer, multiple myeloma, and neuroblastoma, and hematological. malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Dose escalation period: DXC006 is administered intravenously every two weeks (Q2W) at the dose corresponding to the enrolled dose cohort. Dose expansion period: DXC006 is administered intravenously Q2W at the corresponding dose.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGNumber of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated.
Time frame: 28 days
Number of participants with adverse events (AEs)
The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.
Time frame: After first infusion of study drug, Through study completion an average of 1 year
Maximum observed serum or plasma concentration (Cmax)
One of the pharmacokinetics parameters for DXC006investigator shall assess the relationship between the events and investigational product.
Time frame: Through study completion an average of 1 year
Maximum serum drug time(Tmax)
One of the pharmacokinetics parameters for DXC006.
Time frame: Through study completion an average of 1 year
Apparent volume of distribution(Vd)
One of the pharmacokinetics parameters for DXC006.
Time frame: Through study completion an average of 1 year
Volume of distribution at steady state (Vss)
One of the pharmacokinetics parameters for DXC006.
Time frame: Through study completion an average of 1 year
Terminal phase elimination half life (t½)
One of the pharmacokinetics parameters for DXC006.
Time frame: Through study completion an average of 1 year
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Area under the serum or plasma concentration time curve from 0 to the last measurable point (AUC0-t)
One of the pharmacokinetics parameters for DXC006.
Time frame: Through study completion an average of 1 year
Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)
One of the pharmacokinetics parameters for DXC006.
Time frame: Through study completion an average of 1 year
Clearance (CL)
One of the pharmacokinetics parameters for DXC006.
Time frame: Through study completion an average of 1 year
Anti-drug antibodies (ADA)
The titer,neutralizing activity and positive rate of anti-drug antibody (ADA).
Time frame: Through study completion an average of 1 year
Objective Response Rate (ORR)
As determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, which will be complete response (CR) + partial response (PR).
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Duration of response (DOR)
DOR is defined as the time from the date of the first documentation of response (confirmed CR or confirmed PR) to the date of the first documentation of PD or death due to any cause, whichever occurs first.
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the earlier of the dates of the first documentation of progressive disease or death due to any cause.
Time frame: om date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year