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JOURNAL ONKOLOGIE – STUDIE
FORTITUDE-301

A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

Rekrutierend

NCT-Nummer:
NCT05325866

Studienbeginn:
September 2022

Letztes Update:
09.08.2024

Wirkstoff:
Bemarituzumab

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Studienlocations
(3 von 113)

City of Hope National Medical Center
91010 Duarte
United StatesRekrutierend» Google-Maps
University of California Irvine
92868 Orange
United StatesRekrutierend» Google-Maps
Rocky Mountain Cancer Centers
80012 Aurora
United StatesRekrutierend» Google-Maps
Community Health Network MD Anderson Cancer Center - North
46250 Indianapolis
United StatesAbgeschlossen» Google-Maps
Texas Oncology - Dallas Fort Worth
75246 Dallas
United StatesRekrutierend» Google-Maps
University of Texas MD Anderson Cancer Center
77030 Houston
United StatesAbgeschlossen» Google-Maps
US Oncology Regulatory Affairs Corporate Office
75063 Irving
United StatesRekrutierend» Google-Maps
US Oncology Research Investigational Products Center
75063 Irving
United StatesRekrutierend» Google-Maps
Texas Oncology Northeast Texas
75702 Tyler
United StatesRekrutierend» Google-Maps
Instituto Alexander Fleming
C1426ANZ Capital Federal
ArgentinaRekrutierend» Google-Maps
Hospital Aleman
C1118AAT Ciudad Autonoma de Buenos Aires
ArgentinaRekrutierend» Google-Maps
Fundacion Cenit Para La Investigacion
C1125ABD Ciudad Autonoma de Buenos Aires
ArgentinaRekrutierend» Google-Maps
Hospital Italiano de La Plata
1900 La Plata
ArgentinaRekrutierend» Google-Maps
Sociedad de Beneficencia Hospital Italiano
5000 Cordoba
ArgentinaRekrutierend» Google-Maps
Fundacion Medica de Rio Negro y Neuquen
8324 Cipolletti
ArgentinaRekrutierend» Google-Maps
Centro Oncologico Korben
1426 Buenos Aires
ArgentinaRekrutierend» Google-Maps
St John of God Murdoch Hospital
6150 Murdoch
AustraliaRekrutierend» Google-Maps
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
1200 Bruxelles
BelgiumRekrutierend» Google-Maps
Universitair Ziekenhuis Antwerpen
2650 Edegem
BelgiumRekrutierend» Google-Maps
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
3000 Leuven
BelgiumRekrutierend» Google-Maps
Hospital das Clinicas da Ufmg
30130-100 Belo Horizonte
BrazilRekrutierend» Google-Maps
Centro de Oncologia Mackenzie
80440-220 Curitiba
BrazilRekrutierend» Google-Maps
Associacao Hospitalar Moinhos de Vento
90035-001 Porto Alegre
BrazilRekrutierend» Google-Maps
Instituto do Cancer Arnaldo Vieira de Carvalho
01221-020 Sao Paulo
BrazilRekrutierend» Google-Maps
Beneficencia Portuguesa de Sao Paulo - Bp
01323-900 Sao Paulo
BrazilRekrutierend» Google-Maps
Oncoclinicas Rio de Janeiro S A
22250-905 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
4000 Plovdiv
BulgariaRekrutierend» Google-Maps
Complex Oncology Center Plovdiv EOOD
4004 Plovdiv
BulgariaRekrutierend» Google-Maps
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
1606 Sofia
BulgariaRekrutierend» Google-Maps
The Ottawa Hospital Cancer Centre
K1H 8L6 Ottawa
CanadaRekrutierend» Google-Maps
Princess Margaret Cancer Centre
M5G 1Z5 Toronto
CanadaRekrutierend» Google-Maps
Fakultni nemocnice Hradec Kralove
500 05 Hradec Kralove
CzechiaRekrutierend» Google-Maps
Fakultni nemocnice Kralovske Vinohrady
100 34 Praha 10
CzechiaRekrutierend» Google-Maps
Institut de Cancerologie de l Ouest Rene Gauducheau
49055 Angers Cedex 02
FranceRekrutierend» Google-Maps
Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz
25030 Besancon cedex
FranceRekrutierend» Google-Maps
Institut Paoli Calmettes
13272 Marseille Cedex 09
FranceRekrutierend» Google-Maps
Institut regional du Cancer Montpellier
34298 Montpellier Cedex 5
FranceRekrutierend» Google-Maps
Centre Hospitalier Lyon Sud
69495 Pierre-Benite
FranceRekrutierend» Google-Maps
Institut Claudius Regaud
31059 Toulouse cedex 9
FranceRekrutierend» Google-Maps
University Hospital of Heraklion
71500 Heraklion - Crete
GreeceRekrutierend» Google-Maps
European Interbalkan Medical Center
57001 Thessaloniki
GreeceRekrutierend» Google-Maps
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
4400 Nyiregyhaza
HungaryRekrutierend» Google-Maps
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
5000 Szolnok
HungaryRekrutierend» Google-Maps
Hadassah Ein-Kerem Medical Center
9112001 Jerusalem
IsraelRekrutierend» Google-Maps
Tel-Aviv Sourasky Medical Center
6423906 Tel Aviv
IsraelRekrutierend» Google-Maps
Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS
10060 Candiolo TO
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
71100 Foggia
ItalyRekrutierend» Google-Maps
Azienda Unita Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano
30035 Mirano
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Pisana
56126 Pisa
ItalyRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa-shi
JapanRekrutierend» Google-Maps
Kindai University Hospital
589-8511 Osakasayama-shi
JapanRekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Chuo-ku
JapanRekrutierend» Google-Maps
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
135-8550 Koto-ku
JapanRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
138-736 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Investigacion Onco Farmacéutica S de RL de CV
23040 La Paz
MexicoAbgebrochen» Google-Maps
Centro de Infusion e Investigacion Oncologia de Saltillo
25279 Saltillo
MexicoRekrutierend» Google-Maps
Investigacion Biomedica para el Desarrollo de Farmacos
03103 Ciudad de Mexico
MexicoRekrutierend» Google-Maps
Health Pharma Professional Research SA de CV
03100 Mexico City
MexicoRekrutierend» Google-Maps
Christus Muguerza Clinica Vidriera
64570 Monterrey
MexicoAbgebrochen» Google-Maps
Universitair Medisch Centrum Groningen
9713 GZ Groningen
NetherlandsRekrutierend» Google-Maps
Radboud Universitair Medisch Centrum
6525 GA Nijmegen
NetherlandsRekrutierend» Google-Maps
Instytut Centrum Zdrowia Matki Polki
93-338 Lodz
PolandRekrutierend» Google-Maps
Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo
08-110 Siedlce
PolandRekrutierend» Google-Maps
Centrum Medyczne Pratia Poznan
60-185 Skorzewo
PolandRekrutierend» Google-Maps
Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier
1440-005 Lisboa
PortugalRekrutierend» Google-Maps
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
1649-035 Lisboa
PortugalRekrutierend» Google-Maps
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
400015 Cluj Napoca
RomaniaRekrutierend» Google-Maps
Centrul de Oncologie Sf Nectarie SRL
200347 Craiova
RomaniaRekrutierend» Google-Maps
Institutul Regional de Oncologie Iasi
700483 Iasi
RomaniaRekrutierend» Google-Maps
Hospital Clinico Universitario Virgen de la Victoria
29010 Malaga
SpainRekrutierend» Google-Maps
Next Oncology IOB Hospital Quironsalud Barcelona
08023 Barcelona
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Santiago
15706 Santiago de Compostela
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Maranon
28009 Madrid
SpainRekrutierend» Google-Maps
Hopitaux Universitaires de Geneve
1205 Geneve
SwitzerlandRekrutierend» Google-Maps
Christie Hospital
M20 4BX Manchester
United KingdomRekrutierend» Google-Maps
Weston Park Hospital
S10 2SJ Sheffield
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The primary objectives of this study are to observe the safety and tolerability of

bemarituzumab and to evaluate preliminary antitumor activity.

Ein-/Ausschlusskriterien

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.

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).

Studien-Rationale

Primary outcome:

1. Part 1: Number of Participants Who Experience a Dose Limiting Toxicity (DLT) (Time Frame - Day 1 to Day 28)

2. Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) (Time Frame - Day 1 to 28 days after last dose (a maximum of 2 years)):
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.

3. Part 1: Number of Participants Who Experience a Treatment-related Adverse Event (Time Frame - Day 1 to 28 days after last dose (a maximum of 2 years))

4. Part 2: Objective Response (OR) Rate (Time Frame - Up to approximately 2 years):
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).

Secondary outcome:

1. Part 1: OR Rate (Time Frame - Up to approximately 2 years):
OR = CR + PR, measured by CT or MRI as determined by investigator per RECIST v1.1.

2. Parts 1 and 2: Disease Control (DC) Rate (Time Frame - Up to approximately 2 years):
DC = CR, PR, or stable disease (SD).

3. Parts 1 and 2: Duration of Response (DOR) (Time Frame - Up to approximately 2 years):
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.

4. Parts 1 and 2: Time to Response (Time Frame - Up to approximately 2 years)

5. Parts 1 and 2: Progression-free Survival (PFS) (Time Frame - Up to approximately 2 years):
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).

6. Parts 1 and 2: Overall Survival (OS) (Time Frame - Up to approximately 2 years):
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.

7. Part 2: Number of Participants Who Experience a TEAE (Time Frame - Day 1 to 28 days after last dose (a maximum of 2 years)):
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.

8. Part 2: Number of Participants Who Experience a Treatment-related AE (Time Frame - Day 1 to 28 days after last dose (a maximum of 2 years))

9. Parts 1 and 2: Area Under the Concentration Time Curve (AUC) of Bemarituzumab (Time Frame - Day 1 to 28 days after last dose (a maximum of 2 years))

10. Parts 1 and 2: Maximum Observed Serum Concentration (Cmax) of Bemarituzumab (Time Frame - Day 1 to 28 days after last dose (a maximum of 2 years))

11. Parts 1 and 2: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab (Time Frame - Day 1 to 28 days after last dose (a maximum of 2 years))

Studien-Arme

  • 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.

Geprüfte Regime

  • Bemarituzumab (AMG 552):
    Intravenous (IV) infusion.

Quelle: ClinicalTrials.gov


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"A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression"

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