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This is the first-in-human, Phase I, open-label, multiple-ascending dose study to investigate the safety, tolerability, PK, PharmDyn, and clinical activity of IMC-002 in subjects with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas.
Male or female subjects 18 years and older with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas will be included in the study if they meet all the inclusion criteria and none of the exclusion criteria.
The study will consist of 2 parts:
Part 1: Dose Escalation Part 2: Expansion Cohorts
Part 1: Dose Escalation
Part 2: Expansion Cohort The study may be amended in the future to include expansion cohorts in selected tumor types to further evaluate extended safety of IMC-002 at recommended Phase 2 dose in that tumor type. Sample size in the Dose Expansion part will be determined when the study is amended to include the expansion cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-002 | Experimental | Dose escalation will follow the traditional 3+3 design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-002 | Biological | IMC-002 blocks the interaction between CD47 and SIRPα. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of dose-limiting toxicities (DLT) | For 28 days | |
| Incidence and severity of adverse events (AEs) | 2 years |
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Inclusion Criteria
Subjects are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria
Subjects are excluded from the study if any of the following criteria apply:
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| Name | Affiliation | Role |
|---|---|---|
| HEUNG TAE KIM | ImmuneOncia Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine - Siteman Cancer Center | St Louis | Missouri | 63110 | United States | ||
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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Dose escalation will consist of two distinct sub-parts (1A and 1B).
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| The University of Texas MD Anderson Cancer Center |
| Houston |
| Texas |
| 77030 |
| United States |
| NEXT Oncology | San Antonio | Texas | 78229 | United States |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |