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| Name | Class |
|---|---|
| Lepu Biopharma Co., Ltd. | INDUSTRY |
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This is an open-label, multi-center, phase I study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of MRG007 (ARR-217) in patients with unresectable locally advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRG007 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRG007 | Drug | MRG007 will be administrated as specified in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) - Phase Ia | Baseline to Day 21 of the first treatment cycle | |
| Serious Adverse Events (SAEs) | Adverse events that are fatal, life-threatening, or result in hospitalization or prolonged hospitalization, persistent or significant disability/incapacity/substantial disruption of the ability to lead a normal life, congenital anomaly/birth defect or major medical events or reactions | Baseline to 30 days after the last dose of study treatment |
| Treatment-Emergent Adverse Event (TEAE) | AEs that occur or worsen on or after the first dose of study treatment | Baseline to 30 days after the last dose of study treatment |
| Treatment-Related Adverse Event | Any reaction, side effect, or untoward event that occurs during the course of the clinical trial is considered related to the study drug. | Baseline to 30 days after the last dose of study treatment |
| Objective Response Rate (ORR) as assessed by investigator - Phase Ib | ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1. | Baseline to study completion (up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) - Phase Ia | ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1. | Baseline to study completion (up to 24 months) |
| Disease Control Rate (DCR) |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Priya Wason | Contact | 1-925-808-8293 | ARR217CT@ArriVent.com | |
| Program Director | Contact | clinicaltrials@lepubiopharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ULCA | Recruiting | Los Angeles | California | 90095 | United States | |
| UCSF |
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DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment. |
| Baseline to study completion (up to 24 months) |
| Duration of Response (DOR) | The time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier. | Baseline to study completion (up to 24 months) |
| Progression Free Survival (PFS) as assessed by investigator | PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause. | Baseline to study completion (up to 24 months) |
| Overall Survival (OS) | OS is defined as the duration from the start of treatment to death of any cause. | Baseline to study completion (up to 24 months) |
| Incidence of anti-drug antibody (ADA) | The proportion of patients with positive ADA results. | Baseline to 30 days after the last dose. |
| Incidence of neutralizing antibody (NAb) | The proportion of patients with positive NAb results. | Baseline to 30 days after the last dose. |
| Tmax | Time to reach the maximum blood concentration | Baseline to 30 days after the last dose of study treatment |
| Cmax | Maximum observed blood concentration | Baseline to 30 days after the last dose of study treatment |
| AUC0-t | Area under the blood concentration-time curve from time 0 to the time of last quantifiable concentration | Baseline to 30 days after the last dose of study treatment |
| Not yet recruiting |
| San Francisco |
| California |
| 94158 |
| United States |
| University of Colorado | Recruiting | Aurora | Colorado | 80010 | United States |
| Sarah Cannon Research Institute | Recruiting | Denver | Colorado | 80218 | United States |
| Sarah Cannon Research Institute | Recruiting | Sarasota | Florida | 34232 | United States |
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| NEXT Dallas | Recruiting | Irving | Texas | 75039 | United States |
| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Beijing Gobroad Hospital | Recruiting | Beijing | Beijing Municipality | 102200 | China |
| Army Medical Center of PLA | Recruiting | Chongqing | Chongqing Municipality | 400000 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Recruiting | Zhejiang | Hangzhou | 310000 | China |
| Harbin Medical University Cancer Hospital | Recruiting | Heilongjiang | Harbin | 150000 | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | China |
|
| Cancer Hospital of Shandong First Medical University | Recruiting | Shandong | Jinan | 250000 | China |
| Renji Hospital Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Zhongshan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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