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The objective of this study is to assess the safety and tolerability of MRG002 in combination with HX008 in patients with HER2-expressed advanced malignant solid tumors; and to , explore the maximum tolerated dose (MTD), and to determine the recommended phase II dose (RP2D) of combination therapy; , and to evaluate the preliminary efficacy, pharmacokinetics, and immunogenicity of combination therapy in the targeted study population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRG002+HX008 | Experimental | MRG002 will be administrated via intravenous infusion at 1.8,,2.2, or 2.6 mg/kg , (if appropriate) once on Day 1 of every 3 weeks (21-day cycle), up to 24 months. HX008 will be administrated via intravenous infusion at 3 mg/kg once on Day 1 of every 3 weeks (21-day- cycle), up to 24 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRG002+HX008 | Drug | Administrated intravenously |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicity (DLT) in each dose group | DLT is defined as any of the treatment emergent adverse events (TEAE) as specified in the protocol that bear a definite, probable, or possible causal relationship to study drug administration within 28 days after the first dose. | Within 28 days after the first dose. |
| Adverse events | Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug. | After signing informed consent until 90 days after the last dose. |
| Recommended Phase II Dose (RP2D) | The dose level of MRG002 recommended for further clinical studies based on assessment of the safety, efficacy and PK data from this study. | Baseline to study completion (up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the proportion of subjects with CR and PR according to RECIST v1.1. | Baseline to study completion (up to 24 months) |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Program Director | Contact | 86-21-61637960 | clinicaltrials@miracogen.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jin Li, MD | Shanghai Oriental Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
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DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.
| Baseline to study completion (up to 24 months) |
| Disease Control Rate (DCR) | DCR is defined as the proportion of subjects achieving CR, PR, and SD after treatment. | Baseline to study completion (up to 24 months) |
| Progression Free Survival (PFS) | 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) |
| Time to Response (TTR) | TTR is defined as the time from the start of treatment until the first occurrence of CR or PR by tumor assessment. | 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) |
| PK parameters: concentration-time curve | Plot of drug concentration changing with time after drug administration. | Baseline to 90 days after the last dose. |
| Immunogenicity (ADA) | The proportion of patients with positive ADA results. | Baseline to 90 days after the last dose. |
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410200 | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250000 | China |
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| Shanghai Oriental Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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