Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 1/Phase 2
Amgen (Voir sur ClinicalTrials)
septembre 2022
février 2026
16 septembre 2025
The primary objectives of this study are to observe the safety and tolerability of
bemarituzumab and to evaluate preliminary antitumor activity.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Yohann LORIOT | 27/05/2024 14:02:27 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz - 25030 - Besancon - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59020 - Lille Cedex - France | Contact (sur clinicalTrials) | ||||
| Hopital Lyon sud - 69495 - Pierre-Benite - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie de l Ouest Rene Gauducheau - 49055 - Angers Cedex 02 - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - 13272 - Marseille Cedex 09 - France | Contact (sur clinicalTrials) | ||||
| Institut regional du Cancer Montpellier - 34298 - Montpellier Cedex 5 - France | Contact (sur clinicalTrials) | ||||
| Institut Universitaire du Cancer Toulouse Oncopole - 31059 - Toulouse cedex 9 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
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.
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).