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| Name | Class |
|---|---|
| Heidelberg Pharma AG | INDUSTRY |
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This study is a 2-part study with a dose-escalation part and a dose-expansion part. The aim of the dose-escalation part is to determine the maximum tolerated dose (MTD) and/or establish the recommended Phase 2 dose (RP2D) in the Chinese population, in order to select the treatment dose for the dose-expansion part. The dose-escalation part will be followed by the dose-expansion part once the MTD(s) and/or RP2D of HDP-101 monotherapy in the Chinese population have been determined. The dose-expansion part of the study is intended to collect preliminary evidence of antitumor activity and to confirm the safety of the HDP-101 as monotherapy in Chinese patients with r/r MM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDP-101 | Experimental | Participants will receive HDP-101 intravenously in a 21 day cycle until disease progression, intolerable toxicity, Investigator's discretion or patient withdrawal. During the part 1 tolerability of two or three different dose levels will be evaluated. During the part 2 dose expansion part the recommended phase 2 dose (RP2D) of HDP-101 will be administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDP-101 | Drug | HDP-101 is available as lyophilized white powder for preparation of infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who experience a dose-limiting toxicity (DLT) during the first cycle of treatment. | Up to Day 21 (from first dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with serious and non-serious adverse events | Incidence and grading of adverse events (AEs) and serious adverse events (SAEs) (based on the National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE] version 5.0). Incidence of treatment interruption and dose adjustment due to AEs and changes in laboratory tests, vital signs, physical examination and electrocardiogram (ECG). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianfei Zhao | Contact | +8618428347838 | zhaojianfei@eastchinapharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100020 | China | |
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| Through study completion, an average of 1 year |
| Objective response rate (ORR) | Proportion of enrolled subjects who achieve a partial response (PR) or better, i.e. stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and PR, according to the IMWG criteria. | Through study completion, an average of 1 year |
| Minimal residual disease (MRD) negativity rate | Proportion of enrolled subjects who achieve minimal residual disease (MRD) free status, according to the IMWG criteria. | Through study completion, an average of 1 year |
| 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, whichever occurs first as determined by the investigator | Through study completion, an average of 1 year |
| Duration of response (DOR) | DOR is defined as the interval from the first documentation of PR or better until disease progression or death due to any cause, whichever occurs first | Through study completion, an average of 1 year |
| Time to objective response (TOR) | TOR is defined as the interval from the start of study therapy to the first documentation of PR or better | Through study completion, an average of 1 year |
| Overall survival (OS) | OS is defined as the time from randomization to death due to any cause | Through study completion, an average of 1 year |
| The First Affiliated Hospital of Soochow University |
| Recruiting |
| Suzhou |
| Jiangsu |
| 215006 |
| China |
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
| Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310003 | China |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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