This is a phase Ib/II clinical study. All participants are patients with advanced colorectal cancer (CRC). The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor efficacy of HDM2017 in combination with standard of care in patients with advanced CRC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Following a predefined dose and date.
Following a predefined dose and date.
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Maximum Tolerated Dose (MTD)
The MTD will be determined using DLTs
Time frame: 30 days after the last dose of IMP]
Recommended Phase 2 Dose (RP2D)
The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Time frame: 30 days after the last dose of IMP
Type, incidence and severity of Adverse Events
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v6.0
Time frame: 30 days after the last dose of IMP
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).
Time frame: 30 days after the last dose of IMP
Tmax
Time to reach the maximum blood concentration
Time frame: 30 days after the last dose of IMP]
Cmax
Maximum observed blood concentration
Time frame: 30 days after the last dose of IMP
Incidence of anti-drug antibody (ADA)
The proportion of patients with positive ADA results
Time frame: 30 days after the last dose of IMP
Disease control rate (DCR)
DCR is defined as the proportion of subjects with response of CR, PR and SD (based on RECIST Version 1.1)
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Time frame: 30 days after the last dose of IMP
Duration of Response (DoR)
The time from first documented evidence of CR or PR until time of first documented disease progression.
Time frame: 30 days after the last dose of IMP
Progression Free Survival (PFS)
PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause
Time frame: 30 days after the last dose of IMP
Overall survival (OS)
OS is defined as the time from first dose until death due to any cause
Time frame: 30 days after the last dose of IMP