What this study is
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?
What's being tested
- NTB-928
Intervention · DRUG
NTB-928 is an investigational study drug administered as an intravenous infusion.
Study details
- Official title
- A Phase 1 Multicenter, Open-Label, Dose-Escalation and Expansion Study of NTB-928, a FRα-Targeting Bispecific T Cell Engager, in Subjects With Relapsed/Refractory Ovarian Carcinoma
- Sponsor
- TeneoSeven, Inc.
- Conditions
- Relapsed/Refractory Ovarian Carcinoma
- Enrolling
- 90 people
- Starts
- 2026-06-29
- Est. completion
- 2029-02
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openThe University of Alabama
Birmingham, Alabama, United States
RecruitingUniversity of Nebraska Medical Center
Omaha, Nebraska, United States
RecruitingSTART Northwell, LLC
Lake Success, New York, United States
RecruitingStart Ccbd, Llc
Fort Worth, Texas, United States
Recruiting
Study team
Sponsor
TeneoSeven, Inc.
Study ID NTB928.01
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.