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.
Be able and willing to provide written informed consent.
Male or female participants with age ≥ 18 years.
Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal adenocarcinoma.
Be able to provide archived tumor tissue during the screening period.
Participants who have previously received treatment with an anti-VEGFR tyrosine kinase inhibitor (TKI).
Participants who have previously received ADC therapy containing Top I inhibitors, or other drug therapy targeting the CDH17 target.
Participants with other malignant tumors within the past 5 years, other than the tumor being treated in this study, with the exception of locally cured tumors (such as basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix or breast).
Related AEs from prior therapy (except for alopecia and ≤Grade 2 sensory neuropathy) have not recovered to ≤Grade 1 or baseline level.
Single group
HDM2017
DrugFollowing a predefined dose and date.
Fruquintinib
DrugFollowing a predefined dose and date.
Maximum Tolerated Dose (MTD)
The MTD will be determined using DLTs
Recommended Phase 2 Dose (RP2D)
The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Type, incidence and severity of Adverse Events
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v6.0
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).
Tmax
Time to reach the maximum blood concentration
Cmax
Maximum observed blood concentration
Incidence of anti-drug antibody (ADA)
The proportion of patients with positive ADA results
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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This trial is not recruiting at the moment. You can still explore other options:
