Stopped: After completion of all planned dose levels in the dose escalation phase, the sponsor decision was not to continue with expanding the cohorts of any of the dose levels, using the existing study design.
The primary purpose is to assess the safety and tolerability of tilvestamab following IV administration of multiple doses to participants with HGSOC who have been treated with at least 1 complete course of platinum-based chemotherapy and whose disease has relapsed with platinum resistance (\[PRR\]-HGSOC) and to determine the plasma pharmacokinetics (PK) exposure by comprehensive profiling (at single dose and steady-state) of multiple ascending doses of tilvestamab.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants with Adverse events (AEs) and Serious AEs (SAEs)
Timeframe: Up to 2.5 years
Number of Participants with Laboratory Abnormalities
Timeframe: Up to 2.5 years
Number of Participants with Vital Sign Abnormalities
Timeframe: Up to 2.5 years
Number of Participants with Electrocardiogram (ECG) Abnormalities
Timeframe: Up to 2.5 years
Number of Participants with Physical Examinations Abnormalities
Timeframe: Up to 2.5 years
Number of Participants with Concomitant Medication Use
Timeframe: Up to 2.5 years
Maximum Concentration (Cmax)
Timeframe: Up to 140 days
Time to Cmax (Tmax)
Timeframe: Up to 140 days
Area Under the Concentration-time Curve (AUC) From Predose (Time 0) to the end of the Dosing Period (AUC0-tau)
Timeframe: Up to 140 days
AUC From Predose (Time 0) to the Time of the Last Quantifiable Concentration (AUClast)
Timeframe: Up to 140 days
AUC From Predose (Time 0) to 168 Hours Postdose (AUC0-168 )
Timeframe: Predose up to 168 hours postdose
Terminal Elimination Rate Constant (Lambda[z])
Timeframe: Up to 140 days
Terminal Elimination Half-life
Timeframe: Up to 140 days
Total body clearance (CL)
Timeframe: Up to 140 days