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To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced solid tumors.
This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm dose-escalation study of MEDI1873 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and anti-tumor activity in adult subjects with advanced solid tumor malignancies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy arm | Experimental | MEDI1873 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI1873 | Biological | Subjects will receive MEDI1873 by intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) | The maximum tolerated dose (MTD)/highest protocol-defined dose level in the absence of establishing an MTD will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, DLTs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results. | From time of informed consent through 12 months after last dose of MEDI1873 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1 | Estimated to be from time of informed consent up to 4.5 years |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medimmune LLC | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85054 | United States | ||
| Research Site |
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The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1
| Estimated to be from time of informed consent up to 4.5 years |
| Duration of response (DoR) | Duration of response will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first. | Estimated to be from time of informed consent up to 4.5 years |
| Progression-free survival (PFS) | Progression-free survival will be measured from the start of treatment with MEDI1873 until the first documentation of disease progression or death due to any cause, whichever occurs first. | Estimated to be from time of informed consent up to 4.5 years |
| Overall survival (OS) | Overall survival will be determined as the time from the start of treatment with MEDI1873 until death due to any cause. | Estimated to be from time of informed consent up to 4.5 years |
| Maximum observed concentration (Cmax) of MEDI1873 | The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration | From first dose of MEDI1873 through to 30 days after last dose of MEDI1873 |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | The immunogenicity of MEDI1873 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs) | From first dose of MEDI1873 through to 12 months after last dose of MEDI1873 |
| PD biomarkers including changes from baseline levels in various lymphocyte populations | PD biomarkers including changes from baseline levels in various lymphocyte populations | From time of informed consent through to disease progression, assessed up to 4.5 years |
| Area under the curve (AUC) of MEDI1873 | The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration | From first dose of MEDI1873 through to 30 days after last dose of MEDI1873 |
| Clearance (CL) of MEDI1873 | The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration | From first dose of MEDI1873 through to 30 days after last dose of MEDI1873 |
| Terminal half-life of MEDI1873 | The endpoint for assessment of PK of MEDI1873 include serum concentrations of MEDI1873 at different timepoints after MEDI1873 administration | From first dose of MEDI1873 through to 30 days after last dose of MEDI1873 |
| Percentage of subjects who develop detectable anti-drug antibodies (ADAs) | The immunogenicity of MEDI1873 will be assessed by summarizing the percentage of subjects who develop detectable anti-drug antibodies (ADAs) | From first dose of MEDI1873 through to 12 months after last dose of MEDI1873 |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Research Site | Los Angeles | California | 90025 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Rochester | Minnesota | 55905 | United States |
| Research Site | New York | New York | 10032 | United States |
| Research Site | Oklahoma City | Oklahoma | 73117 | United States |
| Research Site | Philadelphia | Pennsylvania | 19111 | United States |
| Research Site | Nashville | Tennessee | 37203 | United States |
| Research Site | Houston | Texas | 77521 | United States |