Relapsed/Refractory Ovarian Carcinoma
Conditions
Keywords
Ovarian Cancer, Ovarian Carcinoma, High Grade Serous Ovarian Carcinoma, Endometrioid Ovarian Carcinoma, Low Grade Serous Ovarian Carcinoma, Ovarian Carcinosarcoma, Clear Cell Carcinoma of the Ovary
Brief summary
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: * What side effects do participants experience when receiving NTB-928, including side effects that limit how much of it can be safely given? * How is NTB-928 processed by the body at different dose levels? * Does the immune system react to NTB-928 during treatment? * What dose of NTB-928 can be given safely that shows early signs of activity against ovarian cancer?
Interventions
DRUGNTB-928
NTB-928 is an investigational study drug administered as an intravenous infusion.
Sponsors
TeneoSeven, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Have a confirmed diagnosis of ovarian cancer, including high-grade serous, high-grade endometrioid, low-grade serous, or clear cell ovarian cancer, or carcinosarcoma of the ovary. Patients with mucinous carcinoma are not eligible. * Have relapsed or refractory ovarian cancer and have already received standard treatments known to provide benefit; participants are eligible if they have platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer (with clearly documented ineligibility for further platinum chemotherapy). * Are able to understand the study requirements and are willing to provide written informed consent * Are willing to use effective birth control during the study and for a period after the last dose of study treatment, if of childbearing potential
Exclusion criteria
* Have another active cancer that could interfere with assessment of this study treatment * Have received another investigational drug or certain cancer treatments within a recent period before starting this study * Are pregnant or breastfeeding
Design outcomes
Primary
| Measure | 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) | 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 |
Secondary
| Measure | 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 |
| Progression-free survival (PFS), based on RECIST v1.1 | Up to approximately 3 years |
| Overall survival (OS) | Up to approximately 3 years |
Countries
United States
Contacts
CONTACTClinical Trial Information
Outcome results
None listed