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

NCT04893551TerminatedPHASE1INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

BerGenBio ASA

Enrollment

16

Start Date

2021-02-25

Completion Date

2022-06-27

Study Type

INTERVENTIONAL

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

Interventions

Tilvestamab

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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

Secondary Outcomes

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

Locations

Haukeland University Hospital Bergen, Bergen, Norway

National University Hospital, Singapore, Singapore

Samsung Medical Center, Seoul, South Korea

Seoul National University Hospital, Seoul, South Korea

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