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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

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

ArmDescriptionAssigned Intervention
Experimental
NTB-928 Treatment
  • Drug: NTB-928
    NTB-928 is an investigational study drug administered as an intravenous infusion.

Recruiting Locations

START Northwell, LLC
Lake Success, New York 11042

Start Ccbd, Llc
Fort Worth, Texas 76104

More Details

Status
Recruiting
Sponsor
TeneoSeven, Inc.

Study Contact

Clinical Trial Information
510-392-0929
clinicaltrial@92biotech.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.