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This is a first in human (FIH), Phase 1, dose escalation and expansion study in select solid tumors. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B).
This is a FIH, Phase 1, open-label, multicenter, multiple-dose, dose escalation and expansion study. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B). NEOK001 is a bispecific B7-H3 x ROR1 exatecan antibody-drug conjugate (ADC) that will be administered intravenously once every cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental |
| |
| Expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEOK001 | Drug | Escalating doses of NEOK001 |
| |
| NEOK001 RDE |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Incidence and Severity of Dose-Limiting Toxicities (DLTs) | Incidence and severity of DLTs during the first cycle of treatment in Part A | 21 Days |
| Part A: Incidence and Severity of Adverse Events (AEs) | Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in participants in Part A | Through study completion, estimated as 32 months |
| Part B: Investigator Assessment of Objective Response Rate (ORR) | Percentage of participants who achieve a confirmed objective response (ORR) | Through study completion, estimated as 32 months |
| Part B: Duration of Response (DOR) | The time from the first documentation of tumor response (complete or partial) until disease progression or death. | Through study completion, estimated as 32 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Incidence of AEs | Incidence of TEAEs and SAEs in participants in Part B | Through study completion, estimated as 32 months |
| Maximum Concentration (Cmax) | Assessment of plasma pharmacokinetics (PK) of NEOK001 maximum observed concentration (Cmax) of NEOK001. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Willie J Hudson, MS | Contact | 615-507-4263 | whudson@neokbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Not yet recruiting | New York | New York | 10065 | United States |
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Dose Escalation followed by Expansion
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| Drug |
Recommended Dose of NEOK001 for Expansion |
|
| 21 days |
| Terminal Elimination Half Life (T1/2) | Assessment of plasma PK of NEOK001 terminal elimination half-life (T1/2). | 21days |
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| NEXT Oncology | Not yet recruiting | Austin | Texas | 78758 | United States |
|
| NEXT Oncology | Not yet recruiting | Dallas | Texas | 75039 | United States |
|
| MD Anderson Cancer Center | Not yet recruiting | Houston | Texas | 77030 | United States |
|
| NEXT Oncology | Not yet recruiting | Houston | Texas | 77054 | United States |
|
| NEXT Oncology | Recruiting | San Antonio | Texas | 78299 | United States |
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| NEXT Oncology | Not yet recruiting | Fairfax | Virginia | 22031 | United States |
|
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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