Clinical trial NCT04893551: A Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Participants
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Ovarian Neoplasms
Lead sponsor: BerGenBio ASA
Sponsor class: INDUSTRY
First posted: 2021-05-19
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Adverse events (AEs) and Serious AEs (SAEs)
timeFrame: Up to 2.5 years
measure: Number of Participants with Laboratory Abnormalities
timeFrame: Up to 2.5 years
measure: Number of Participants with Vital Sign Abnormalities
timeFrame: Up to 2.5 years
measure: Number of Participants with Electrocardiogram (ECG) Abnormalities
timeFrame: Up to 2.5 years
measure: Number of Participants with Physical Examinations Abnormalities
timeFrame: Up to 2.5 years
measure: Number of Participants with Concomitant Medication Use
timeFrame: Up to 2.5 years
measure: Maximum Concentration (Cmax)
timeFrame: Up to 140 days
measure: Time to Cmax (Tmax)
timeFrame: Up to 140 days
measure: 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
measure: AUC From Predose (Time 0) to the Time of the Last Quantifiable Concentration (AUClast)
timeFrame: Up to 140 days
measure: AUC From Predose (Time 0) to 168 Hours Postdose (AUC0-168 )
timeFrame: Predose up to 168 hours postdose
measure: Terminal Elimination Rate Constant (Lambda[z])
timeFrame: Up to 140 days
measure: Terminal Elimination Half-life
timeFrame: Up to 140 days
measure: Total body clearance (CL)
timeFrame: Up to 140 days
Secondary outcomes:
measure: Number of Participants with Anti-drug Antibodies (ADAs)
timeFrame: Up to 2.5 years
measure: Number of Participants with Neutralizing Antibodies (NAbs)
timeFrame: Up to 2.5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System- Severance Hospital
city: Bergen
country: Norway
facility: Haukeland University Hospital Bergen
city: Singapore
country: Singapore
facility: National University Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: Guys and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College London, Hammersmith Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: BerGenBio ASA
name: Akil Jackson
role: STUDY_DIRECTOR
References: