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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001382-36 | EudraCT Number |
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After completion of all planned dose levels in the dose escalation phase, the sponsor decision was not to continue with expanding the cohorts of any of the dose levels, using the existing study design.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tilvestamab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tilvestamab | Biological | Tilvestamab will be administered as IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Number of Participants with Physical Examinations Abnormalities | Number of participants with physical examinations abnormalities will be reported. | Up to 2.5 years |
| Number of Participants with Concomitant Medication Use | Number of participants with concomitant medication use will be reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Anti-drug Antibodies (ADAs) | Number of participants with ADAs will be reported. | Up to 2.5 years |
| Number of Participants with Neutralizing Antibodies (NAbs) | Number of participants with NAbs will be reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akil Jackson | BerGenBio ASA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital Bergen | Bergen | Norway | ||||
| National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40696160 | Derived | Sooi K, Tan TZ, Kim JW, Lee JY, Kim BG, Micklem D, Jackson A, Pinato DJ, Gourley C, Kristeleit R, Blagden SP, Bjorge L, Tan DSP. A phase 1b, multicentre, dose escalation, safety and pharmacokinetics study of tilvestamab (BGB149) in relapsed, platinum-resistant, high-grade serous ovarian cancer (PROC) patients. Br J Cancer. 2025 Oct;133(6):896-908. doi: 10.1038/s41416-025-03090-6. Epub 2025 Jul 22. |
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Individual participant data that underlie the results reported in the article, after deidentification [text, tables, figures and appendices].
Beginning 3 months and ending 5 years following article publication
Proposal should be directed to HYPERLINK "mailto:clinical@bergenbio.com" clinical@bergenbio.com. To gain access, data requestors will need to sign a data access agreement.
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| Up to 2.5 years |
| Maximum Concentration (Cmax) | Cmax will be determined directly from the concentration-time profile. | Up to 140 days |
| Time to Cmax (Tmax) | Time to Cmax will be determined directly from the concentration-time profile. | 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. | 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. | 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. | 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. | Up to 140 days |
| Terminal Elimination Half-life | Terminal elimination half-life calculated as: ln2/Lambda[z] | Up to 140 days |
| Total body clearance (CL) | CL is defined as total body clearance. | Up to 140 days |
| Up to 2.5 years |
| 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 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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