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Study Comparing Bemarituzumab plus Chemotherapy with Placebo and Chemotherapy in Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b Overexpression (FORTITUDE-101)
EU CTIS ID: 2023-505457-40-00
What this study is testing
To compare efficacy of bemarituzumab plus mFOLFOX6 to placebo plus mFOLFOX6 as assessed by overall survival (OS) in subjects with FGFR2b ≥ 10% 2+/3+ tumor cell staining (FGFR2b ≥ 10% 2+/3+ TC)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject has provided informed consent prior to initiation of any study specific activities/procedures.
- Age ≥18 years (or legal adult age within country, whichever is older)
- Histologically documented gastric or GEJ adenocarcinoma (not amenable to curative therapy). Primary tumor location will be classified following the American Joint Committee on Cancer/Union for International Cancer Control [AJCC/UICC] 8th edition.
- Disease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy)
- FGFR2b ≥ 10% 2+/3+ TC as determined by centrally performed IHC testing, based on tumor sample
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
You likely can't join if
- Untreated or symptomatic central nervous system (CNS) metastases and leptomeningeal disease Subjects with asymptomatic CNS metastases are eligible if clinically stable for at least 4 weeks and do not require intervention (including use of corticosteroids). Subjects with treated brain metastases are eligible provided the following criteria are met: Definitive therapy was completed at least 2 weeks prior to the first planned dose of study treatment (stereotactic radiosurgery at least 7 days prior to first planned dose of study treatment) At least 7 days prior to first dose of study treatment: any CNS disease is clinically stable, subject is off steroids for CNS disease (unless steroids are indicated for a reason unrelated to CNS disease), and subject is off or on stable doses of anti-epileptic drugs
- History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmic corticosteroids
- Evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute (within 4 weeks) or actively progressing
- History of other malignancy within the past 2 years, except: curatively treated non-melanoma skin malignancy cervical cancer in situ curatively treated uterine cancer stage I curatively treated ductal or lobular breast carcinoma in situ and not currently receiving any systemic therapy localized prostate cancer that has been treated surgically with curative intent and presumed cured
- Evidence of, or recent (within 6 months) history of, corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer. Recent (within 6 months) corneal surgery or ophthalmic laser treatment
- Prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of mFOLFOX6 Prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, if completed more than 6 months prior to the first dose of study treatment Palliative radiotherapy is allowed, provided it has been completed more than 14 days prior to the first dose of study treatment All treatment-related toxicity needs to be resolved to grade ≤ 1 prior to the first dose of study treatment, with the exception of alopecia or toxicities considered irreversible (defined as having been present and stable for > 21 days) which are not otherwise described in the exclusion criteria
See the full eligibility criteria
Who can join
- Subject has provided informed consent prior to initiation of any study specific activities/procedures.
- Age ≥18 years (or legal adult age within country, whichever is older)
- Histologically documented gastric or GEJ adenocarcinoma (not amenable to curative therapy). Primary tumor location will be classified following the American Joint Committee on Cancer/Union for International Cancer Control [AJCC/UICC] 8th edition.
- Disease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy)
- FGFR2b ≥ 10% 2+/3+ TC as determined by centrally performed IHC testing, based on tumor sample
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate organ function as follows: absolute neutrophil count ≥ 1.5 x 109/L platelet count ≥ 100 x 109/L hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment aspartate aminotransferase and ALT < 3x upper limit of normal (ULN) (or < 5 x ULN if liver involvement). Total bilirubin < 1.5 x ULN (or < 2 x ULN if liver involvement; with the exception of subjects with Gilbert's disease) calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) x Mass [kg]/[72 x Creatinine mg/dL]) (x 0.85 if female) international normalized ratio or prothrombin time (PT) < 1.5 x ULN except for subjects receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment
- Measurable disease or non-measurable, but evaluable disease, according to RECIST v1.1.
- Subject has no contraindications to mFOLFOX6 chemotherapy
What rules you out
- Untreated or symptomatic central nervous system (CNS) metastases and leptomeningeal disease Subjects with asymptomatic CNS metastases are eligible if clinically stable for at least 4 weeks and do not require intervention (including use of corticosteroids). Subjects with treated brain metastases are eligible provided the following criteria are met: Definitive therapy was completed at least 2 weeks prior to the first planned dose of study treatment (stereotactic radiosurgery at least 7 days prior to first planned dose of study treatment) At least 7 days prior to first dose of study treatment: any CNS disease is clinically stable, subject is off steroids for CNS disease (unless steroids are indicated for a reason unrelated to CNS disease), and subject is off or on stable doses of anti-epileptic drugs
- History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmic corticosteroids
- Evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute (within 4 weeks) or actively progressing
- History of other malignancy within the past 2 years, except: curatively treated non-melanoma skin malignancy cervical cancer in situ curatively treated uterine cancer stage I curatively treated ductal or lobular breast carcinoma in situ and not currently receiving any systemic therapy localized prostate cancer that has been treated surgically with curative intent and presumed cured
- Evidence of, or recent (within 6 months) history of, corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer. Recent (within 6 months) corneal surgery or ophthalmic laser treatment
- Prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of mFOLFOX6 Prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, if completed more than 6 months prior to the first dose of study treatment Palliative radiotherapy is allowed, provided it has been completed more than 14 days prior to the first dose of study treatment All treatment-related toxicity needs to be resolved to grade ≤ 1 prior to the first dose of study treatment, with the exception of alopecia or toxicities considered irreversible (defined as having been present and stable for > 21 days) which are not otherwise described in the exclusion criteria
- Prior treatment with any selective inhibitor of the FGF-FGFR pathway
- Currently receiving treatment in another investigational device or drug study, or within 28 days of first dose of study treatment or during this clinical study. Other investigational procedures while participating in this study are excluded
- Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 9 months after the last dose of protocol-mandated therapy
- Female subjects who are breastfeeding or plan to breastfeed while on study through 3 months after the last dose of protocol-mandated therapy
- Female subjects planning to become pregnant while on study through 9 months after the last dose of protocol-mandated therapy
- Unwillingness to avoid use of contact lenses during study treatment
- Female subjects of childbearing potential with a positive pregnancy test assessed at screening and within 72 hours prior to first dose of study treatment
- Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 6 months after the last dose of protocol-mandated therapy.
- Male subjects unwilling to abstain from donating sperm during treatment and for an additional 6 months after the last dose of protocol-mandated therapy
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures within the subject's capacity to the best of the subject and investigator’s knowledge
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Known allergy, hypersensitivity, or contraindication to components of the bemarituzumab formulation including polysorbate
- Major surgical procedure within 28 days prior to first dose of study treatment
- 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 mm Hg despite optimal treatment (measured following European Society for Hypertension/European Society of Cardiology [ESH/ESC] 2018 guidelines); uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, active coronary artery disease, QTc ≥ 470 msec
- Peripheral sensory neuropathy G2 or higher
- Active infection requiring systemic treatment or any uncontrolled infection ≤14 days prior to first dose of study treatment
- Known positive HER2 status (as defined by positive IHC test of 3+ or IHC 2+ with positive in situ hybridization [ISH])
- Known human immunodeficiency virus (HIV) infection with CD4+ T-cell (CD4+) counts < 350 cells/µL, hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response following antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen [SAg] or core antibody that achieve sustained virologic response with antiviral therapy directed at hepatitis B are allowed)
- History of interstitial lung disease
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- South Africa
- Russian Federation
- China
- Mexico
- Australia
- Israel
- Japan
- Malaysia
- Korea, Republic of
- Turkey
- Taiwan
- Singapore
- Argentina
- Brazil
- Chile
- Thailand
- Peru
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; South Africa; Russian Federation; China; Mexico; Australia and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.