A Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Participants

Ovarian Neoplasms Clinical Trial

Official title:

Phase 1b, Multicentre, Multiple Ascending Dose, Safety, Pharmacokinetic, and Pharmacodynamic Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04893551
• Other study ID #: BGB149-102
• Secondary ID: 2020-001382-36
• Status: Terminated
• Phase: Phase 1
• Start date: February 25, 2021
• Est. completion date: June 27, 2022

Study information

• Verified date: April 2023
• Source: BerGenBio ASA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: June 27, 2022
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Females of non-childbearing potential at the time of provision of informed consent

• Ability to understand and provide written confirmation of informed consent after reading study information, discussion with the investigator, and adequate time to decide on participation

• Consents to storage of study-related samples and data for exploratory use

• Histologically confirmed HGSOC

• Platinum-resistant relapsed disease; defined as progressive disease based on imaging within <= 6 months from completion of most recent regimen

Exclusion Criteria:

• Primary platinum-refractory disease (ie, progression during the first platinum regimen or within 4 weeks of completion of the first platinum regimen) with rapid progression and life-threatening disease manifestation

• Life expectancy < 6 months

• Concurrent anticancer therapy

• Participants who are breastfeeding

• Known uncontrolled central nervous system metastases. Participants without known brain metastases do not require radiological imaging prior to enrolment

Related Conditions & MeSH terms

• Ovarian Neoplasms

Intervention

Biological:
• Tilvestamab
Tilvestamab will be administered as IV infusion.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Health System- Severance Hospital	Seoul
Norway	Haukeland University Hospital Bergen	Bergen
Singapore	National University Hospital	Singapore
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
BerGenBio ASA

Countries where clinical trial is conducted

Korea, Republic of,  Norway,  Singapore,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 2.5 years
Primary	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.	Up to 2.5 years
Primary	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.	Up to 2.5 years
Primary	Number of Participants with Electrocardiogram (ECG) Abnormalities	Number of participants with resting triplicate 12-lead ECG abnormalities will be reported.	Up to 2.5 years
Primary	Number of Participants with Physical Examinations Abnormalities	Number of participants with physical examinations abnormalities will be reported.	Up to 2.5 years
Primary	Number of Participants with Concomitant Medication Use	Number of participants with concomitant medication use will be reported.	Up to 2.5 years
Primary	Maximum Concentration (Cmax)	Cmax will be determined directly from the concentration-time profile.	Up to 140 days
Primary	Time to Cmax (Tmax)	Time to Cmax will be determined directly from the concentration-time profile.	Up to 140 days
Primary	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.	Up to 140 days
Primary	AUC From Predose (Time 0) to the Time of the Last Quantifiable Concentration (AUClast)	AUClast will be calculated using the linear-log trapezoidal rule.	Up to 140 days
Primary	AUC From Predose (Time 0) to 168 Hours Postdose (AUC0-168 )	AUC0-168 is AUC from predose (time 0) to 168 hours postdose.	Predose up to 168 hours postdose
Primary	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.	Up to 140 days
Primary	Terminal Elimination Half-life	Terminal elimination half-life calculated as: ln2/Lambda[z]	Up to 140 days
Primary	Total body clearance (CL)	CL is defined as total body clearance.	Up to 140 days
Secondary	Number of Participants with Anti-drug Antibodies (ADAs)	Number of participants with ADAs will be reported.	Up to 2.5 years
Secondary	Number of Participants with Neutralizing Antibodies (NAbs)	Number of participants with NAbs will be reported.	Up to 2.5 years