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NCT Number: NCT07690189

Study of NTB-928 in R/R OC

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?

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Key information

Conditions

Relapsed/Refractory Ovarian Carcinoma Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

START Northwell, LLC, Lake Success, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NTB-928

Drug

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

Primary outcomes

  1. Number of dose-limiting toxicities (DLTs) within the first cycle of treatment with NTB-928

    Time frame: Up to 35 days

  2. 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

  3. Maximum plasma concentration (Cmax)

    Time frame: Up to approximately 3 years

  4. Time to Cmax (Tmax)

    Time frame: Up to approximately 3 years

  5. Area under the plasma concentration-time curve (AUC) over the dosing interval (AUC0-T)

    Time frame: Up to approximately 3 years

  6. AUC from time zero to time t (AUC0-t)

    Time frame: Up to approximately 3 years

  7. AUC from time 0 extrapolated to infinity (AUC0-∞)

    Time frame: Up to approximately 3 years

  8. Terminal elimination half-life (t½)

    Time frame: Up to approximately 3 years

  9. Clearance (CL)

    Time frame: Up to approximately 3 years

  10. Terminal elimination rate constant (λz)

    Time frame: Up to approximately 3 years

  11. Volume of distribution (Vz)

    Time frame: Up to approximately 3 years

  12. Accumulation ratio (Rac) for Cmax and AUC, and trough concentration (Ctrough)

    Time frame: Up to approximately 3 years

  13. Number of participants with anti-drug antibodies (ADA) at baseline and after treatment

    Time frame: Up to approximately 3 years

Secondary outcomes

  1. Objective response rate (ORR), based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Time frame: Up to approximately 3 years

  2. Duration of objective response (DOR), based on RECIST v1.1

    Time frame: Up to approximately 3 years

  3. Progression-free survival (PFS), based on RECIST v1.1

    Time frame: Up to approximately 3 years

  4. Overall survival (OS)

    Time frame: Up to approximately 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Information

CONTACT

[email protected]

510-392-0929

Sponsors and collaborators

Lead sponsor

TeneoSeven, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 8, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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