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

BerGenBio

Status and phase: Terminated; Phase 1

Conditions: Ovarian Neoplasms

Treatments: Biological: Tilvestamab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04893551

2020-001382-36 (EudraCT Number)

BGB149-102

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Tilvestamab

Experimental group

Description:

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.

Treatment:

Biological: Tilvestamab