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FORTITUDE-301 - A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors With FGFR2b Overexpression

Studio Clinico

Patologia: Neoplasie della mammella, Neoplasie del polmone, Tumori delle vie biliari, Tumori dell’utero, Tumori dell’ovaio, Tumori della testa e del collo, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Randomizzato: No

Fase di studio: 1, I B, II

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Age ≥ 18 years (or legal adult age within country, whichever is older) at the time that the Informed Consent Form (ICF) is signed
- 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
- Disease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy)
- Tumor overexpresses FGFR2b as determined by centrally performed immunohistochemistry (IHC) testing
- Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function as determined per protocol.

Criteri di esclusione: 

- Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
- Other solid tumor cohort excludes primary tumors of the CNS, squamous non-small cell lung cancer, gastric adenocarcinoma, and gastroesophageal junction adenocarcinoma
- 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
- History of systemic disease or ophthalmologic disorders requiring chronic use of ophthalmic steroids
- Evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute (within 4 weeks) or actively progressing
- Unwillingness to avoid use of contact lenses during study treatment and for at least 100 days after the end of treatment
- 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
- Prior treatment with any investigational selective inhibitor of the fibroblast growth factor (FGF)/FGF receptor pathway (unless approved standard of care for tumor indication).

Schema di trattamento: 

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 IV infusion 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.

Trattamento sperimentale: 

Bemarituzumab

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

IRCCS Candiolo (TO)
St.Provinciale Km 3,95 SP142 - 10060 Candiolo - TO

Telefono: 0119933844
Email: ufficio.trials@ircc.it

 

ULSS 3 Serenissima - Distretto Mirano-Dolo
Via Mariutto 76 - 30035 Mirano - VE
U.O.C. Oncologia ed Ematologia Oncologica

 

Sud Italia e isole

AOU Ospedali Riuniti di Foggia
Viale Luigi Pinto 1 - 71121 Foggia - FG
U.O. Oncologia Medica e Terapia Biomolecolare

Email: oncologiaterapbiomolecolare@ospedaliriunitifoggia.it

 

ASL Napoli 1 Centro - Ospedale del Mare
Via Enrico Russo - 80147 Napoli - NA
UOC Oncologia

Email: oncologia.odm@aslnapoli1centro.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-006386-38 - NCT05325866

Data di inserimento: 24.10.2024

Promotore

Amgen

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na

 

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