Study of NTB-928 in R/R OC

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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. 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?

Eligibility

Primary outcome measure(s)

• Number of dose-limiting toxicities (DLTs) within the first cycle of treatment with NTB-928 — Up to 35 days
• Number of participants with adverse events (AEs) and serious adverse events (SAEs), by severity and relatedness to NTB-928 — Up to approximately 3 years
• Maximum plasma concentration (Cmax) — Up to approximately 3 years
• Time to Cmax (Tmax) — Up to approximately 3 years
• Area under the plasma concentration-time curve (AUC) over the dosing interval (AUC0-T) — Up to approximately 3 years
• AUC from time zero to time t (AUC0-t) — Up to approximately 3 years
• AUC from time 0 extrapolated to infinity (AUC0-∞) — Up to approximately 3 years
• Terminal elimination half-life (t½) — Up to approximately 3 years
• Clearance (CL) — Up to approximately 3 years
• Terminal elimination rate constant (λz) — Up to approximately 3 years
• Volume of distribution (Vz) — Up to approximately 3 years
• Accumulation ratio (Rac) for Cmax and AUC, and trough concentration (Ctrough) — Up to approximately 3 years
• Number of participants with anti-drug antibodies (ADA) at baseline and after treatment — Up to approximately 3 years

Trial sites (4)