Study of NTB-928 in R/R OC

July 9, 2026 updated by: TeneoSeven, Inc.

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

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • START Northwell, LLC
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Start Ccbd, Llc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NTB-928 Treatment
Drug: NTB-928
NTB-928 is an investigational study drug administered as an intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of dose-limiting toxicities (DLTs) within the first cycle of treatment with NTB-928
Time Frame: Up to 35 days
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
Up to approximately 3 years
Maximum plasma concentration (Cmax)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Time to Cmax (Tmax)
Time Frame: Up to approximately 3 years
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
Up to approximately 3 years
AUC from time zero to time t (AUC0-t)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
AUC from time 0 extrapolated to infinity (AUC0-∞)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Terminal elimination half-life (t½)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Clearance (CL)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Terminal elimination rate constant (λz)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Volume of distribution (Vz)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Accumulation ratio (Rac) for Cmax and AUC, and trough concentration (Ctrough)
Time Frame: Up to approximately 3 years
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
Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
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
Up to approximately 3 years
Duration of objective response (DOR), based on RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Progression-free survival (PFS), based on RECIST v1.1
Time Frame: Up to approximately 3 years
Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TeneoSeven, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 9, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTB928.01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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