CompletedPhase 1/2

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

United States260 participantsStarted 2022-09-23

Plain-language summary

The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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.

Exclusion criteria

✕. 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).

What they're measuring

Part 1: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)

Timeframe: Day 1 to Day 28

Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)

Part 1: Number of Participants Who Experience a Treatment-related Adverse Event

Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)

Part 2: Objective Response (OR) Rate

Timeframe: Up to approximately 2 years

Trial details

NCT IDNCT05325866

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-28

View on ClinicalTrials.gov More Solid Tumors trials

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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.

Exclusion criteria

✕. 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).

What they're measuring

Part 1: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)

Timeframe: Day 1 to Day 28

Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)

Part 1: Number of Participants Who Experience a Treatment-related Adverse Event

Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)

Part 2: Objective Response (OR) Rate

Timeframe: Up to approximately 2 years