Recruiting
Phase 1

NTB-928

Sponsor:

TeneoSeven, Inc.

Code:

NCT07690189

Conditions

Relapsed/Refractory Ovarian Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NTB-928

Study Details

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?

Conditions

Relapsed/Refractory Ovarian Carcinoma

Study ID

NCT07690189

Start date

Jun 29, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NTB-928 Treatment

Interventions

NTB-928

NTB-928 is an investigational study drug administered as an intravenous infusion.

Primary outcome measure

  • Number of dose-limiting toxicities (DLTs) within the first cycle of treatment with NTB-928 [ Time Frame: Up to 35 days ]
  • Number of participants with adverse events (AEs) and serious adverse events (SAEs), by severity and relatedness to NTB-928 [ Time Frame: Up to approximately 3 years ]
  • Maximum plasma concentration (Cmax) [ Time Frame: Up to approximately 3 years ]
  • Time to Cmax (Tmax) [ Time Frame: Up to approximately 3 years ]
  • Area under the plasma concentration-time curve (AUC) over the dosing interval (AUC0-T) [ Time Frame: Up to approximately 3 years ]
  • AUC from time zero to time t (AUC0-t) [ Time Frame: Up to approximately 3 years ]
  • AUC from time 0 extrapolated to infinity (AUC0-∞) [ Time Frame: Up to approximately 3 years ]
  • Terminal elimination half-life (t½) [ Time Frame: Up to approximately 3 years ]
  • Clearance (CL) [ Time Frame: Up to approximately 3 years ]
  • Terminal elimination rate constant (λz) [ Time Frame: Up to approximately 3 years ]
  • Volume of distribution (Vz) [ Time Frame: Up to approximately 3 years ]
  • Accumulation ratio (Rac) for Cmax and AUC, and trough concentration (Ctrough) [ Time Frame: Up to approximately 3 years ]
  • Number of participants with anti-drug antibodies (ADA) at baseline and after treatment [ Time Frame: Up to approximately 3 years ]

Central Contacts and Locations

Central contacts

Clinical Trial Information

510-392-0929clinicaltrial@92biotech.com

Locations

The University of Alabama

Recruiting

Birmingham, Alabama, United States, 35294-0111

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198-7878

START Northwell, LLC

Recruiting

Lake Success, New York, United States, 11042

Start Ccbd, Llc

Recruiting

Fort Worth, Texas, United States, 76104

More Information

Sponsor

TeneoSeven, Inc.

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by TeneoSeven, Inc. on 2026-08-20.