Relapsed/Refractory Ovarian CarcinomaPhase 1NCT07690189
Study of NTB-928 in R/R OC
A Phase 1 study testing NTB-928 in people with Relapsed/Refractory Ovarian Carcinoma, run by TeneoSeven, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Relapsed/Refractory Ovarian Carcinoma
- What is being tested?
- NTB-928
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Jun 2026to Feb 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
The University of Alabama
Birmingham, Alabama, 35294-0111
- Recruiting
Start Ccbd, Llc
Fort Worth, Texas, 76104
- Recruiting
START Northwell, LLC
Lake Success, New York, 11042
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7878
About this study
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
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
- Being tested
- NTB-928
- 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
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTB-928Drug
NTB-928 is an investigational study drug administered as an intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| NTB-928 Treatment | Experimental | Not described Receives: Drug: NTB-928 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dose-limiting toxicities (DLTs) within the first cycle of treatment with NTB-928
Measured: Up to 35 days
Number of participants with adverse events (AEs) and serious adverse events (SAEs), by severity and relatedness to NTB-928
Measured: Up to approximately 3 years
Maximum plasma concentration (Cmax)
Measured: Up to approximately 3 years
Time to Cmax (Tmax)
Measured: Up to approximately 3 years
Area under the plasma concentration-time curve (AUC) over the dosing interval (AUC0-T)
Measured: Up to approximately 3 years
AUC from time zero to time t (AUC0-t)
Measured: Up to approximately 3 years
AUC from time 0 extrapolated to infinity (AUC0-∞)
Measured: Up to approximately 3 years
Terminal elimination half-life (t½)
Measured: Up to approximately 3 years
Clearance (CL)
Measured: Up to approximately 3 years
Terminal elimination rate constant (λz)
Measured: Up to approximately 3 years
Volume of distribution (Vz)
Measured: Up to approximately 3 years
Accumulation ratio (Rac) for Cmax and AUC, and trough concentration (Ctrough)
Measured: Up to approximately 3 years
Number of participants with anti-drug antibodies (ADA) at baseline and after treatment
Measured: Up to approximately 3 years
Secondary outcomes (4)
Objective response rate (ORR), based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Measured: Up to approximately 3 years
Duration of objective response (DOR), based on RECIST v1.1
Measured: Up to approximately 3 years
Progression-free survival (PFS), based on RECIST v1.1
Measured: Up to approximately 3 years
Overall survival (OS)
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start29 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TeneoSeven, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690189
- Sponsor's protocol ID
- NTB928.01
- Status last verified
- Aug 2026
- First submitted
- 2 Jul 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07690189
- Acronym / sponsor ID
- NTB928.01
- Conditions
- Relapsed/Refractory Ovarian Carcinoma
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- TeneoSeven, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NTB-928 Treatment | Experimental | Drug: NTB-928 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTB-928NTB-928 is an investigational study drug administered as an intravenous infusion. | Drug | NTB-928 Treatment |
Primary outcome
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
4 secondary outcomes
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
Duration of objective response (DOR), based on RECIST v1.1
Time frame: Up to approximately 3 years
Progression-free survival (PFS), based on RECIST v1.1
Time frame: Up to approximately 3 years
Overall survival (OS)
Time frame: Up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NTB-928 in people with Relapsed/Refractory Ovarian Carcinoma, run by TeneoSeven, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Information (510-392-0929, clinicaltrial@92biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of dose-limiting toxicities (DLTs) within the first cycle of treatment with NTB-928 (time frame: Up to 35 days). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.