A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201)

Stopped early · Phase 1

Conditions studied: Squamous-Cell Non-Small-Cell Lung Cancer

In brief

The primary objectives of this study are to evaluate the safety and tolerability of bemarituzumab monotherapy and combination with other anti-cancer therapies, and to determine the recommended phase 3 dose of bemarituzumab in combination with other anti-cancer therapies.

Key facts

Study ID

NCT05267470

Run by

Amgen

People needed

74

Starts

2022-03-29

Expected to finish

2024-05-28

Last updated by the study team

2025-03-25

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures
• Age ≥ 18 years old (or legal adult within country, whichever is older) at the time that the Informed Consent Form (ICF) is signed
• Pathologically confirmed squamous cell lung carcinoma
• Disease that is unresectable, locally advanced or metastatic (not amenable to curative therapy)
• Participants must have archived tumor tissue sample (formalin fixed, paraffin embedded [FFPE] sample [FFPE of excisional, or core needle]) taken within last 5 years or be willing to undergo pre-treatment tumor biopsy (excisional, or core needle) for tissue prior to enrollment
• Participant must have progressed on, or recurred after at least 1 prior systemic therapy (Part 1 and 2 only) or at least 2 prior systemic therapies (Part 3 only) for locally advanced and unresectable or metastatic disease. Prior treatment must include a platinum-based doublet chemotherapy and checkpoint inhibitor for advanced or metastatic disease, either given as one line of therapy or as individual lines of therapy, unless the participant has a medical contraindication to one of the required therapies (which must be documented in the electronic case report form [eCRF]). Additionally, if the participant's tumor was previously identified as having a driver mutation (according to local standard of care or guidelines, e.g., Kirsten rat sarcoma [KRAS] G12C, neurotrophic tyrosine receptor kinase [NTRK]), which has an approved therapy for which the participant is eligible and available, the participant must have received the approved therapy in a prior line of treatment.
• For Part 4, participants may not have received prior systemic therapy for their locally advanced and unresectable or metastatic disease. For Part 4, participants who received peri-operative systemic therapy are eligible if that adjuvant/neoadjuvant therapy was completed at least 12 months prior to diagnosis of locally advanced and unresectable or metastatic disease.
• Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function as determined per protocol
• Part 2, 3 and 4 only: FGFR2b overexpression as determined by centrally performed immunohistochemistry (IHC) testing

You may not qualify if…

• Mixed small-cell lung cancer or mixed non-small cell lung cancer (NSCLC) histology
• Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures at a frequency greater than monthly
• 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] 2013 guidelines; Section 11.11), uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, active coronary artery disease, Fridericia's correction formula (QTc) ≥ 470
• Evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute (within 4 weeks) or actively progressing
• 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
• Part 1 and Part 2: participants that experienced toxicity or hypersensitivity requiring discontinuation of prior docetaxel treatment
• Part 1 only: participants that had disease progression on prior therapy with docetaxel
• Part 2 only: participants have received prior docetaxel in unresectable or metastatic setting (including participants who received prior docetaxel in first line for metastatic disease, but not including participants who received prior docetaxel neoadjuvantly or adjuvantly and did not progress within 6 months of end of therapy)
• Prior treatment with any selective inhibitor of the fibroblast growth factor-fibroblast growth factor receptor (FGF-FGFR) pathway

Where it is running

• University of California Irvine — Orange, California, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• Montefiore Einstein Center for Cancer Care — The Bronx, New York, United States
• University of Pittsburgh, Cancer Institute — Pittsburgh, Pennsylvania, United States
• Cliniques Universitaires Saint Luc — Brussels, Belgium
• Universitair Ziekenhuis Antwerpen — Edegem, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Jessa Ziekenhuis - Campus Virga Jesse — Hasselt, Belgium
• Institut Bergonie — Bordeaux, France
• CHU de Lyon - Hopital Louis Pradel — Bron, France
• Hôpital Tenon — Paris, France
• Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie — Poitiers, France
• Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou — Rennes, France
• Institut Gustave Roussy — Villejuif, France
• National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan
• Shizuoka Cancer Center — Sunto-gun, Shizuoka, Japan
• Wakayama Medical University Hospital — Wakayama, Wakayama, Japan
• Przychodnia Lekarska Komed Roman Karaszewski — Konin, Poland
• Pratia Mcm Krakow — Krakow, Poland
• Krakowskie Centrum Medyczne Sp zoo — Krakow, Poland
• Instytut Centrum Zdrowia Matki Polki — Lodz, Poland
• Instytut Genetyki i Immunologii GENIM Spzoo — Lublin, Poland
• Centrum Medyczne Hope Clinic Sebastian Szklener — Lublin, Poland
• Mazowieckie centrum leczenia — Otwock, Poland
• Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea

Full record on ClinicalTrials.gov

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