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This is a phase I clinical study. All subjects are patients with advanced solid tumors. The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, and preliminary antitumor efficacy of HDM2017 in patients with advanced malignant solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDM2017 | Experimental | Participants will receive escalating doses of HDM2017, then at least 2 dose levels will be selected for dose expansion to determine the RP2D |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM2017 | Drug | Participants will be treated with HDM2017 intravenous infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | The MTD will be determined using DLTs | 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 | 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 v5.0 | 30 days after the last dose of IMP |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to reach the maximum blood concentration | 30 days after the last dose of IMP |
| Cmax | Maximum observed blood concentration | 30 days after the last dose of IMP |
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Inclusion Criteria:
Exclusion Criteria:
Participants who have previously received ADC therapy containing Top I inhibitors, or other drug therapy targeting the CDH17 target.
Participants who have received the following treatments:
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.
Known weight loss of >10% within 2 months before the first dose of study drug or other indicators showing severe malnutrition.
History of gastrointestinal perforation, abdominal fistula, or extensive intestinal resection within 6 months before the first dose; complete or incomplete gastrointestinal obstruction or intra-abdominal abscess within 3 months before the first dose.
History of gastrointestinal hemorrhage within 3 months before the first dose, or a clear gastrointestinal hemorrhagic diathesis.
Participants with known active CNS metastasis.
Participants with cardiovascular/cerebrovascular disorder, symptoms, or manifestations.
Participants with active syphilis, history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or active hepatitis C virus (HCV), except for asymptomatic chronic hepatitis B or C virus carriers.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruichao Zeng | Contact | +86-571-89903388 | zengruichao@eastchinapharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Incidence of anti-drug antibody (ADA) | The proportion of patients with positive ADA results | 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). | 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). | 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. | 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. | 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. | 30 days after the last dose of IMP |