Study of NTB-928 in R/R OC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NTB-928.
- Who it may be relevant to
- Registry conditions: Relapsed/Refractory Ovarian Carcinoma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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?
Interventions
- Drug NTB-928
NTB-928 is an investigational study drug administered as an intravenous infusion.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- START Northwell, LLC — Lake Success
- Start Ccbd, Llc — Fort Worth
Identifiers
NCT: NCT07690189 · NTB928.01