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This is a study evaluating the efficacy, safety, and pharmacokinetics ofHDM2005 in participants with metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDM2005 | Experimental | In dose escalation phase, participants will be administered escalating doses of HDM2005 at 1.8~2.5mg/kg IV on Day 1 of repeated 21-day cycles or 1.2~2.0mg/kg IV on Day 1 of repeated 14-day cycles . In dose expansion phase, participants will be administered to recommended dose for expansion (RDE) of HDM2005 . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM2005 | Drug | HDM2005 will be administered via IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicity (DLT) events (for dose escalation phase) | DLT will be determined by definition during the DLT observation period. | up to 21 days or 28 days following first dose |
| Incident and severity of adverse events(for dose escalation phase) | The safety profile of HDM2005 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. | Until 28 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first. |
| Progression-free survival(PFS)(for dose expansion phase) | PFS, defined as the interval from the start of study treatment to the earlier of the first documentation of disease progression or death from any cause per RECIST, Version 1.1. | Approximately 30 months |
| Objective Response Rate (ORR)(for dose expansion phase) | Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator. | Approximately 18 months |
| Recommended Phase 2 Dose (RP2D) (for dose expansion phase) Recommended Phase 2 Dose (RP2D) (for dose expansion phase) Recommended Phase 2 Dose (RP2D) (for dose expansion phase) | The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic,E-R relationships, and efficacy data. The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic and efficacy data. | Approximately 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of HDM2005, total antibody and the free MMAE | Plasma concentration of HDM2005, total antibody and the free MMAE will be reported for each arm. | up to 28 days following last dose |
| Immunogenicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Zhou | Contact | 18061872796 | hdgdzhoujun@eastchinapharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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Number and percentage of anti-drug antibody (ADA)-positive patients will be assessed.
| up to 28 days following last dose |
| Objective Response Rate (ORR)(for dose escalation phase) | Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator. | Approximately 18 months |
| Time to Response (TTR) | TTR is defined as the interval from the start of study therapy to the first documentation of an objective response. | Approximately 30 months |
| Duration of Response (DOR) | DOR is defined as the interval from the first documentation of objective response to the earlier of the first documentation of disease progression/relapse or death from any cause. | Approximately 30 months |
| Overall survival (OS) | OS is defined as the interval from the start of study therapy to death from any cause. | Approximately 30 months |