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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05325866
Registration number
NCT05325866
Ethics application status
Date submitted
6/04/2022
Date registered
13/04/2022
Date last updated
30/05/2024
Titles & IDs
Public title
A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
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Scientific title
A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors With FGFR2b Overexpression (FORTITUDE-301)
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Secondary ID [1]
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20210104
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Universal Trial Number (UTN)
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Trial acronym
FORTITUDE-301
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Solid Tumors
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bemarituzumab
Experimental: Part 1: Monotherapy Dose Exploration - Participants across multiple primary epithelial solid tumors with centrally determined FGFR2b overexpression and relapsed/refractory unresectable and/or metastatic disease will receive 1 of 2 dose regimens of bemarituzumab to determine recommended Phase 2 dose.
Experimental: Part 2: Monotherapy Dose Expansion - Participants across multiple primary epithelial solid tumors with centrally determined FGFR2b overexpression and relapsed/refractory unresectable and/or metastatic disease will receive the dose of bemarituzumab identified as the recommended Phase 2 dose during Part 1.
Treatment: Drugs: Bemarituzumab
Intravenous (IV) infusion.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
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Assessment method [1]
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Timepoint [1]
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Day 1 to Day 28
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Primary outcome [2]
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Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
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Assessment method [2]
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Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests that occur after study treatment administration will be recorded as TEAEs.
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Timepoint [2]
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Day 1 to 28 days after last dose (a maximum of 2 years)
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Primary outcome [3]
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Part 1: Number of Participants Who Experience a Treatment-related Adverse Event
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Assessment method [3]
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Timepoint [3]
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Day 1 to 28 days after last dose (a maximum of 2 years)
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Primary outcome [4]
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Part 2: Objective Response (OR) Rate
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Assessment method [4]
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OR = complete response (CR) + partial response (PR), measured by computed tomography (CT) or magnetic resonance imaging (MRI) as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
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Timepoint [4]
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Up to approximately 2 years
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Secondary outcome [1]
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Part 1: OR Rate
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Assessment method [1]
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OR = CR + PR, measured by CT or MRI as determined by investigator per RECIST v1.1.
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Timepoint [1]
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Up to approximately 2 years
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Secondary outcome [2]
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Parts 1 and 2: Disease Control (DC) Rate
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Assessment method [2]
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DC = CR, PR, or stable disease (SD).
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Timepoint [2]
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Up to approximately 2 years
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Secondary outcome [3]
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Parts 1 and 2: Duration of Response (DOR)
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Assessment method [3]
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DOR, defined as the time from first documentation of OR (as determined by investigator per RECIST v1.1) until the first documentation of disease progression or death due to any cause, whichever occurs first. Only participants who have achieved OR will be evaluated for DOR. DOR will be censored at the last evaluable post-baseline tumor assessment prior to subsequent anticancer therapy.
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Timepoint [3]
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Up to approximately 2 years
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Secondary outcome [4]
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0
Parts 1 and 2: Time to Response
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Assessment method [4]
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0
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Timepoint [4]
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Up to approximately 2 years
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Secondary outcome [5]
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Parts 1 and 2: Progression-free Survival (PFS)
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Assessment method [5]
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PFS, defined as time from first dose of investigational product until the first documentation of radiologic disease progression or death due to any cause. PFS will be censored at the last evaluable post-baseline tumor assessment prior to subsequent therapy. Progression will be based on RECIST v1.1 (derived utilizing investigator tumor assessments).
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Timepoint [5]
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Up to approximately 2 years
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Secondary outcome [6]
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Parts 1 and 2: Overall Survival (OS)
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Assessment method [6]
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OS, defined as time from first dose of investigational product until death from any cause. Participants still alive will be censored at the date last known to be alive.
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Timepoint [6]
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Up to approximately 2 years
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Secondary outcome [7]
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Part 2: Number of Participants Who Experience a TEAE
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Assessment method [7]
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AEs are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests that occur after study treatment administration will be recorded as TEAEs.
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Timepoint [7]
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Day 1 to 28 days after last dose (a maximum of 2 years)
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Secondary outcome [8]
0
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Part 2: Number of Participants Who Experience a Treatment-related AE
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Assessment method [8]
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Timepoint [8]
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Day 1 to 28 days after last dose (a maximum of 2 years)
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Secondary outcome [9]
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Parts 1 and 2: Area Under the Concentration Time Curve (AUC) of Bemarituzumab
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Assessment method [9]
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Timepoint [9]
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Day 1 to 28 days after last dose (a maximum of 2 years)
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Secondary outcome [10]
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Parts 1 and 2: Maximum Observed Serum Concentration (Cmax) of Bemarituzumab
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Assessment method [10]
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0
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Timepoint [10]
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Day 1 to 28 days after last dose (a maximum of 2 years)
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Secondary outcome [11]
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Parts 1 and 2: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab
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Assessment method [11]
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Timepoint [11]
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Day 1 to 28 days after last dose (a maximum of 2 years)
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Eligibility
Key inclusion criteria
1. Age = 18 years (or legal adult age within country, whichever is older) at the time
that the Informed Consent Form (ICF) is signed
2. Histologically or cytologically confirmed cancer of one of the following types,
refractory to or relapsed after at least 1 prior standard therapeutic regimen in the
advanced/metastatic setting, as specified below. If no standard of care therapies
exist for the participant, or the participant cannot tolerate or refuses standard of
care anticancer therapy, the participant may be allowed to participate on the study
after discussion between the investigator and Amgen medical monitor. Participants who
have not received all approved or standard treatments for their cancer must be
informed that these alternatives to receiving bemarituzumab are available prior to
consenting to participate in the trial.
- head and neck squamous cell carcinoma: = 1 line of therapy
- triple-negative breast cancer: = 2 lines of therapy
- Intrahepatic cholangiocarcinoma = 1 line of therapy
- lung adenocarcinoma: at least platinum-based chemotherapy, checkpoint inhibitor,
and targeted therapy
- platinum resistant ovarian epithelial cell carcinoma, including fallopian tube
cancers and primary peritoneal cancers, defined as progression during or within 6
months of a platinum containing regimen: = 1 line of therapy
- endometrial adenocarcinoma: = 1 line of therapy
- cervical carcinoma: = 1 line of therapy
- other solid tumors: = 1 line of therapy
3. Disease that is unresectable, locally advanced, or metastatic (not amenable to
curative therapy)
4. Tumor overexpresses FGFR2b as determined by centrally performed immunohistochemistry
(IHC) testing
5. Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Adequate organ function as determined per protocol.
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal
disease.
2. Other solid tumor cohort excludes primary tumors of the CNS, squamous non-small cell
lung cancer, gastric adenocarcinoma, and gastroesophageal junction adenocarcinoma
3. Impaired cardiac function or clinically significant cardiac disease including:
unstable angina within 6 months prior to first dose of study treatment, acute
myocardial infarction = 6 months prior to first dose of study treatment, New York
Heart Association (NYHA) class II-IV congestive heart failure, uncontrolled
hypertension (defined as an average systolic blood pressure = 160 mmHg or diastolic =
100 mmHg despite optimal treatment, uncontrolled cardiac arrhythmias requiring
anti-arrhythmic therapy other than beta blockers or digoxin, active coronary artery
disease or corrected QT interval QTc = 470
4. History of systemic disease or ophthalmologic disorders requiring chronic use of
ophthalmic steroids
5. Evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute
(within 4 weeks) or actively progressing
6. Unwillingness to avoid use of contact lenses during study treatment and for at least
100 days after the end of treatment
7. Recent (within 6 months) corneal surgery or ophthalmic laser treatment or recent
(within 6 months) history of, or evidence of, corneal defects, corneal ulcerations,
keratitis, or keratoconus, or other known abnormalities of the cornea that may pose an
increased risk of developing a corneal ulcer prior/concomitant therapy
8. Prior treatment with any investigational selective inhibitor of the fibroblast growth
factor (FGF)/FGF receptor pathway (unless approved standard of care for tumor
indication).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/09/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
27/07/2027
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Actual
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Sample size
Target
303
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [3]
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Wollongong Hospital - Wollongong
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Recruitment hospital [4]
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Toowoomba Hospital - Toowoomba
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Recruitment hospital [5]
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Cabrini Hospital - Malvern
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Recruitment hospital [6]
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St John of God Murdoch Hospital - Murdoch
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2031 - Randwick
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Recruitment postcode(s) [3]
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2500 - Wollongong
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Recruitment postcode(s) [4]
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4350 - Toowoomba
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Recruitment postcode(s) [5]
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3144 - Malvern
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Recruitment postcode(s) [6]
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6150 - Murdoch
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Indiana
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United States of America
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Michigan
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United States of America
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Texas
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Argentina
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Buenos Aires
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Argentina
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Córdoba
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Argentina
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Río Negro
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Austria
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Graz
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Austria
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Salzburg
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Leuven
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Rio Grande Do Sul
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São Paulo
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Brazil
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Rio de Janeiro
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Plovdiv
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Sofia
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Ontario
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Brno
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Hradec Kralove
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Olomouc
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Praha 10
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Denmark
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Helsinki
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Finland
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Tampere
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Angers Cedex 02
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Besancon cedex
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Marseille Cedex 09
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Montpellier Cedex 5
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France
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Pierre-Benite
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France
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Toulouse cedex 9
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France
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Villejuif
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Athens
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Heraklion - Crete
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Foggia
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Italy
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Mirano
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Italy
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Napoli
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Italy
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Aichi
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Tokyo
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Korea, Republic of
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Seoul
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Netherlands
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Groningen
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Netherlands
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Nijmegen
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Poland
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Krakow
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Lodz
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Pila
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Siedlce
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Skorzewo
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Portugal
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Lisboa
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Romania
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Cluj Napoca
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Iasi
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Romania
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Timisoara
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Spain
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Andalucía
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Spain
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Galicia
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Switzerland
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Chur
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Switzerland
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Geneve
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United Kingdom
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Manchester
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objectives of this study are to observe the safety and tolerability of
bemarituzumab and to evaluate preliminary antitumor activity.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05325866
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Contact person for public queries
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Amgen Call Center
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Address
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Phone
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866-572-6436
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05325866
Download to PDF