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This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2005 in patients with relapsed/refractory B-cell lymphoma and advanced 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 0.3~2.75mg/kg IV on Day 1 of repeated 21-day cycles. In dose expansion phase, participants will be administered to recommended dose for expansion (RDE) of HDM2005 on Day 1 of repeated 21-day cycles . |
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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 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 |
| 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. | Until withdrawal of consent, loss to follow-up, initiation of other new antineoplastic therapy, end of study, or study termination by the sponsor, whichever occurs first (up to approximately 3.5 years) |
| 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. | Approximately 3.5 years |
| 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, Master | Contact | 18061872796 | hdgdzhoujun@eastchinapharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 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 |
| Incident and severity of adverse events(for dose expansion 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 |
| 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 3.5 years |
| 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 3.5 years |
| Progression free survival (PFS) | PFS is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression/relapse or death from any cause. | Approximately 3.5 years |
| 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 3.5 years |
| Overall survival (OS) | OS is defined as the interval from the start of study therapy to death from any cause. | Approximately 3.5 years |
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | China |
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| The Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | China |
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| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | China |
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| The First Affiliated Hospital Of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | China |
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| Shandong Cancer Hospital | Not yet recruiting | Jinan | Shandong | China |
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| The First Affiliated Hospital of Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
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| The Institute of Hematology and Blood Diseases Hospital at the Chinese Academy of Medical Sciences | Recruiting | Tianjing | China |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
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