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The goal of this clinical trial is to determine if NTB-928 can be given safely to adult females with ovarian cancer that has come back (relapsed) or stopped responding to treatment (refractory), how NTB-928 moves through the body, and how the immune system reacts to it. The study will also look for early signs of anti-cancer activity of NTB-928. The main questions the study aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NTB-928 Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTB-928 | Drug | NTB-928 is an investigational study drug administered as an intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of dose-limiting toxicities (DLTs) within the first cycle of treatment with NTB-928 | Up to 35 days | |
| Number of participants with adverse events (AEs) and serious adverse events (SAEs), by severity and relatedness to NTB-928 | Up to approximately 3 years | |
| Maximum plasma concentration (Cmax) | Up to approximately 3 years | |
| Time to Cmax (Tmax) | Up to approximately 3 years | |
| Area under the plasma concentration-time curve (AUC) over the dosing interval (AUC0-T) | Up to approximately 3 years | |
| AUC from time zero to time t (AUC0-t) | Up to approximately 3 years | |
| AUC from time 0 extrapolated to infinity (AUC0-∞) | Up to approximately 3 years | |
| Terminal elimination half-life (t½) | Up to approximately 3 years | |
| Clearance (CL) | Up to approximately 3 years | |
| Terminal elimination rate constant (λz) | Up to approximately 3 years | |
| Volume of distribution (Vz) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR), based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) | Up to approximately 3 years | |
| Duration of objective response (DOR), based on RECIST v1.1 | Up to approximately 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Information | Contact | 510-392-0929 | clinicaltrial@92biotech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| START Northwell, LLC | Recruiting | Lake Success | New York | 11042 | United States | |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| Up to approximately 3 years |
| Accumulation ratio (Rac) for Cmax and AUC, and trough concentration (Ctrough) | Up to approximately 3 years |
| Number of participants with anti-drug antibodies (ADA) at baseline and after treatment | Up to approximately 3 years |
| Progression-free survival (PFS), based on RECIST v1.1 | Up to approximately 3 years |
| Overall survival (OS) | Up to approximately 3 years |
| Start Ccbd, Llc |
| Recruiting |
| Fort Worth |
| Texas |
| 76104 |
| United States |
| 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 |