This is a multicenter, open-label, dose-escalation/dose-expansion, Phase Ib/II study to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor efficacy of HDM2017 combination therapy in participants with advanced CRC. The study is divided into two periods: dose escalation (Phase Ib) and dose expansion (Phase II). Phase Ib of this study is a dose-finding study of different HDM2017 combination therapies. The Phase II study will be conducted at a dose determined to be safe and potentially effective in Phase Ib.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Administered with continuing until protocol-specified criteria for treatment discontinuation are met
administered with continuing until protocol-specified criteria for treatment discontinuation are met
administered with continuing until protocol-specified criteria for treatment discontinuation are met
administered with continuing until protocol-specified criteria for treatment discontinuation are met
administered with continuing until protocol-specified criteria for treatment discontinuation are met
administered with dosing continuing until protocol-specified criteria for treatment discontinuation are met
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGMaximum 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: From date of first-dosing until the date of first documented progression or date of 30 days after the last dose of IMP, whichever came first, assessed up to about 12 months
Disease control rate (DCR)
Time frame: 30 days after the last dose of IMP
Duration of Response (DoR)
Time frame: From date of confirm ORR until the date of first documented progression, assessed up to about 36 months
Progression Free Survival (PFS)
Time frame: From date of first-dosing/randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to about 36 months
Overall survival (OS)
Time frame: From date of first-dosing/randomization until the end of the trail or date of death from any cause, whichever came first, assessed up to about 48 months
Incidence of anti-drug antibody (ADA)
Time frame: 30 days after the last dose of IMP
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