Study of NTB-928 in R/R OC
Purpose
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?
Condition
- Relapsed/Refractory Ovarian Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts 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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NTB-928 Treatment |
|
Recruiting Locations
Birmingham, Alabama 35294-0111
Omaha, Nebraska 68198-7878
Lake Success, New York 11042
Fort Worth, Texas 76104
More Details
- Status
- Recruiting
- Sponsor
- TeneoSeven, Inc.