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This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.
Part A of the study will evaluate the safety and tolerability of NRM-823. Part B of the study will further evaluate the safety and tolerability of NRM-823 of the recommended dose identified in PART A in an expansion cohort. Part C will evaluate the addition of a checkpoint inhibitor to NRM-823.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NRM-823 | Experimental | Administered per protocol requirements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NRM-823 | Drug | NRM-823 is a bispecific T-Cell Engager |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAE) | Number of participants who experience treatment emergent AEs or SAEs | From enrollment until 30 days post the last dose received by a participant |
| Incidence of dose-limiting toxicities (DLTs) | Number of participants who experience a DLT. A DLTs include protocol defined adverse events. | From enrollment until 30 days post the last dose received by a participant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Judy Schnyder, MBA | Contact | 215-593-7119 | judy.schnyder@normunity.com |
| Name | Affiliation | Role |
|---|---|---|
| Viviana Bozon, MD | Normunity AccelCo, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Normunity Investigational Site | Recruiting | Denver | Colorado | 80220 | United States | |
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| Normunity Investigational Site |
| Recruiting |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| Normunity Investigational Site | Recruiting | Minneapolis | Minnesota | 55425 | United States |
| Normunity Investigational Site | Recruiting | Maumee | Ohio | 43537 | United States |
| Normunity Investigational Site | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Normunity Investigational Site | Recruiting | Nashville | Tennessee | 37203 | United States |
| Normunity Investigational Site | Recruiting | Dallas | Texas | 75230 | United States |
| Normunity Investigational Site | Recruiting | San Antonio | Texas | 78229 | United States |
| Normunity Investigational Site | Recruiting | Fairfax | Virginia | 22031 | United States |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| C562730 | Adenocarcinoma Of Esophagus |
| D010051 | Ovarian Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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