Clinical trial · Interventional
Study of NTB-928 in R/R OC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Ovarian Carcinoma | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NTB-928 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NTB-928 Treatment
- interventionNames
- Drug: NTB-928
Primary outcomes (13)
- measure
- Number of dose-limiting toxicities (DLTs) within the first cycle of treatment with NTB-928
- timeFrame
- Up to 35 days
- measure
- Number of participants with adverse events (AEs) and serious adverse events (SAEs), by severity and relatedness to NTB-928
- timeFrame
- Up to approximately 3 years
- measure
- Maximum plasma concentration (Cmax)
- timeFrame
- Up to approximately 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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