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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Tilvestamab will be administered as IV infusion.
Haukeland University Hospital Bergen
Bergen, Norway
National University Hospital
Singapore, Singapore
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Number of Participants with Adverse events (AEs) and Serious AEs (SAEs)
An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening, worsens during the study, regardless of the suspected cause of the event. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Up to 2.5 years
Number of Participants with Laboratory Abnormalities
Number of participants with laboratory (haematology, coagulation, clinical chemistry, serum inflammatory cytokine profile, and urinalysis) abnormalities will be reported.
Time frame: Up to 2.5 years
Number of Participants with Vital Sign Abnormalities
Number of participants with vital sign (supine blood pressure \[BP\], heart rate, oral temperature, and respiratory rate) abnormalities will be reported.
Time frame: Up to 2.5 years
Number of Participants with Electrocardiogram (ECG) Abnormalities
Number of participants with resting triplicate 12-lead ECG abnormalities will be reported.
Time frame: Up to 2.5 years
Number of Participants with Physical Examinations Abnormalities
Number of participants with physical examinations abnormalities will be reported.
Time frame: Up to 2.5 years
Number of Participants with Concomitant Medication Use
Number of participants with concomitant medication use will be reported.
Time frame: Up to 2.5 years
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Yonsei University Health System- Severance Hospital
Seoul, South Korea
Western General Hospital
Edinburgh, United Kingdom
Guys and St Thomas' NHS Foundation Trust
London, United Kingdom
Imperial College London, Hammersmith Hospital
London, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Maximum Concentration (Cmax)
Cmax will be determined directly from the concentration-time profile.
Time frame: Up to 140 days
Time to Cmax (Tmax)
Time to Cmax will be determined directly from the concentration-time profile.
Time frame: Up to 140 days
Area Under the Concentration-time Curve (AUC) From Predose (Time 0) to the end of the Dosing Period (AUC0-tau)
AUC0-tau will be calculated using the linear-log trapezoidal rule.
Time frame: Up to 140 days
AUC From Predose (Time 0) to the Time of the Last Quantifiable Concentration (AUClast)
AUClast will be calculated using the linear-log trapezoidal rule.
Time frame: Up to 140 days
AUC From Predose (Time 0) to 168 Hours Postdose (AUC0-168 )
AUC0-168 is AUC from predose (time 0) to 168 hours postdose.
Time frame: Predose up to 168 hours postdose
Terminal Elimination Rate Constant (Lambda[z])
Lambda\[z\] will be determined by selection of at least 3 data points on the terminal phase of the concentration-time curve.
Time frame: Up to 140 days
Terminal Elimination Half-life
Terminal elimination half-life calculated as: ln2/Lambda\[z\]
Time frame: Up to 140 days
Total body clearance (CL)
CL is defined as total body clearance.
Time frame: Up to 140 days
Number of Participants with Anti-drug Antibodies (ADAs)
Number of participants with ADAs will be reported.
Time frame: Up to 2.5 years
Number of Participants with Neutralizing Antibodies (NAbs)
Number of participants with NAbs will be reported.
Time frame: Up to 2.5 years