A Phase 1 interventional study of Tilvestamab in Ovarian Neoplasms, sponsored by BerGenBio ASA. Terminated at 9 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-20.
Sponsored by BerGenBio ASA · Phase 1, Interventional, and Treatment
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 16 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →BerGenBio ASA is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive tilvestamab at a low starting dose level (Cohort A) given via intravenous (IV) infusion every 2 weeks. Dose escalations to subsequent cohorts (Cohort B and Cohort C) will be decided by the Protocol Steering Committee (PSC) after review of all Cycle 1 (28 days cycle) safety and pharmacokinetics (PK) data up to Cycle 1 Day 22 for all participants in the ongoing cohort.
Biological: Tilvestamab
Tilvestamab will be administered as IV infusion.
Also known as: BGB149
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
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
Plan to share: Yes — Individual participant data that underlie the results reported in the article, after deidentification \[text, tables, figures and appendices\].
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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BerGenBio ASA