A Phase 1 interventional study of Bemarituzumab and Modified FOLFOX6 in Gastrointestinal Cancer, Gastrointestinal Cancer Metastatic and Gastric Cancer, sponsored by Five Prime Therapeutics, Inc.. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Five Prime Therapeutics, Inc. (part of Amgen) · Phase 1, Interventional, and Treatment
The primary objective of the phase 1 portion of this study is to determine the recommended dose of bemarituzumab in combination with 5-fluorouracil, leucovorin and oxaliplatin (modified FOLFOX6) to use in the phase 2 portion of the trial.
Phase 1 is an open-label dose-escalation of bemarituzumab in combination with modified FOLFOX6 (mFOLFOX6). Eligible patients will have unresectable locally advanced or metastatic GI cancer of any type and be candidates to receive at least 2 doses of mFOLFOX6 chemotherapy. Phase 1 consists of 2 dosing cohorts of bemarituzumab in combination with mFOLFOX6 to determine the recommended dose of bemarituzumab in combination with mFOLFOX6 for the phase 2 portion of the study (see study record NCT03694522).
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's enrollment of 12 is below the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Five Prime Therapeutics, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
First submitted before Five Prime Therapeutics, Inc. became part of Amgen.
Compared within Stomach Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Gastrointestinal Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In sexually active patients (women of and males), willingness to use 2 effective methods of , of which 1 must be a physical barrier method (condom, diaphragm, or cervical/vault cap) until 6 months after the last dose of FPA144. Other effective forms of contraception include:
Adequate hematological and biological function, confirmed by the following laboratory values within 96 hours prior to enrollment:
Bone Marrow Function
Hepatic Function
Renal Function
Exclusion Criteria:
Impaired cardiac function or cardiac disease, including any of the following (Criteria a through g):
History of prior , except (Criteria a through f):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received 6 mg/kg bemarituzumab administered every 2 weeks (Q2W) and mFOLFOX6 chemotherapy administered Q2W until unacceptable toxicity, disease progression, or death.
Biological: Bemarituzumab · Drug: Modified FOLFOX6
Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Biological: Bemarituzumab · Drug: Modified FOLFOX6
Administered by intravenous infusion over approximately 30 minutes
Also known as: FPA144
Modified FOLFOX6 regimen consists of the following: * Oxaliplatin 85 mg/m² IV infusion over 120 minutes * Leucovorin 400 mg/m² IV infusion over 120 minutes, or 200 mg/m² levo-leucovorin if leucovorin is unavailable * 5-fluorouracil (5-FU) 400 mg/m² bolus over approximately 5 minutes then 5-FU 2400 mg/m² as a continuous IV infusion over approximately 48 hours.
Also known as: mFOLFOX6
Number of Participants With Treatment-related Adverse Events ≥ Grade 2
A treatment-related adverse event (TRAE) is defined as an adverse event (AE) with an onset date on or after the date of first dose of study treatment, or an event present before treatment that worsened after treatment, and with an onset date prior to 28 days after the last date of dose, for which the investigator assessed as related to investigational product The investigator classified the severity of each AE using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0 on a scale from mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death due to the AE (Grade 5).
Time frame: From first dose of study drug up to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in the bemarituzumab 6 mg/kg group and 19.4 (4.0, 35.4) weeks in the bemarituzumab 15 mg/kg group.
Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs were defined as any of the following events considered by the investigator to be related to study drug: * Absolute neutrophil count (ANC) \< 0.5 × 10⁹/L \> 5 days duration or febrile neutropenia. * Platelets \< 25 × 10⁹/L or \< 50 × 10⁹/L with bleeding requiring medical intervention or for \> 3 days. * Grade 4 anemia. * Any Grade 2-3 ophthalmologic AE not resolving within 7 days. * Any Grade 4 ophthalmologic AE. * Any Grade 4 laboratory value. * Any Grade 3 laboratory values that are not of clinical significance according to investigator and Sponsor agreement if they do not resolve within 72 hours. * Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≥ 3× upper limit of normal (ULN) and concurrent total bilirubin ≥ 2× ULN not related to liver involvement with cancer. * Any non-hematological AE ≥ Grade 3 (except nausea, vomiting, and diarrhea). * Grade 3 nausea, vomiting or diarrhea not resolving with supportive care in 72 hours. * Grade 4 nausea, vomiting or diarrhea.
Time frame: 28 days
Number of Participants With Treatment-emergent Adverse Events
Treatment-emergent adverse events are defined as adverse events (AEs) that started or worsened between the start of study drug and 28 days after permanent discontinuation of study drug. A serious AE is defined as any untoward medical occurrence that at any dose: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability or incapacity; * Was a congenital anomaly or birth defect. The investigator assessed the causality/relationship between the study treatment and each AE, and assessed the severity of each AE according to the guidelines provided in NCI-CTCAE, version 5.0 on a scale from mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death due to the AE (Grade 5). Ocular events associated with symptomatic corneal involvement and symptomatic and asymptomatic retinal involvement were events of special interest in this study.
Time frame: From first dose of study drug up to 28 days after last dose; Actual median (min, max) duration of the treatment emergent period was 19.3 (12.3, 22.3) weeks in the bemarituzumab 6 mg/kg group and 19.4 (4.0, 35.4) weeks in the bemarituzumab 15 mg/kg group.
Maximum Observed Serum Concentration (Cmax) of Bemarituzumab
Time frame: Cycle 1 day 1 at predose, 0.25, 4, 48, and 168 hours after end of infusion, and for participants in Cohort 2 day 8 at 0.25 and 4 hours end of infusion; Cycle 2 day 1 at predose, 0.25 and 48 hours after end of infusion.
Observed Serum Concentration of Bemarituzumab at the End of the Dose Interval (Ctrough)
Time frame: Cycle 1 day 14 predose for cohort 1 and day 8 predose for cohort 2; Cycle 2 day 14 predose
Area Under the Observed Concentration-time Curve From the Time of Dosing to Day 14 (AUC0-14)
Area under the observed concentration-time curve from the time of dosing to Day 14 (0-336h) calculated by log-linear trapezoidal approximation.
Time frame: Cycle 1 day 1 at predose, 0.25, 4, 48, and 168 hours after end of infusion, and for participants in Cohort 2 day 8 at 0.25 and 4 hours after the end of infusion.
Terminal Half-life (t1/2) of Bemarituzumab
Time frame: Cycle 1 day 1 at predose, 0.25, 4, 48, and 168 hours after end of infusion, and for participants in Cohort 2 day 8 at 0.25 and 4 hours after end of infusion.
Number of Participants With Treatment Induced Anti-bemarituzumab Antibodies
Postbaseline treatment induced antidrug antibody (ADA) positive is defined as participants with * ADA negative at baseline and ADA positive at any postbaseline timepoint, or * ADA positive at baseline and ADA positive with titer of at least 4-fold of the baseline titer at one or more postbaseline timepoint.
Time frame: Samples were collected for ADA analysis predose on day 1 of Cycles 1, 2, 3, 7, and 10 and at 28 days following the last dose.
Study FPA144-004 was a Phase 1/2 study. Phase 1 was a safety run-in to determine the recommended dose of bemarituzumab to be administered in combination with a fixed dose of modified FOLFOX 6 (mFOLFOX6) chemotherapy regimen in the phase 2 part of the study. Phase 1 study results are reported herein; Phase 2 study details and results are reported separately (NCT03694522).
| Milestone | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 |
|---|---|---|
| Started | 3 | 9 |
| Received any study treatment | 3 | 9 |
| Completed | 0 | 0 |
| Not completed | 3 | 9 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Death | 0 | 2 |
| Withdrew: Other | 0 | 6 |
| Withdrew: Missing | 2 | 0 |
A treatment-related adverse event (TRAE) is defined as an adverse event (AE) with an onset date on or after the date of first dose of study treatment, or an event present before treatment that worsened after treatment, and with an onset date prior to 28 days after the last date of dose, for which the investigator assessed as related to investigational product The investigator classified the severity of each AE using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0 on a scale from mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death due to the AE (Grade 5).
| Participants | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events ≥ Grade 2 | 1 | 4 |
DLTs were defined as any of the following events considered by the investigator to be related to study drug: * Absolute neutrophil count (ANC) \< 0.5 × 10⁹/L \> 5 days duration or febrile neutropenia. * Platelets \< 25 × 10⁹/L or \< 50 × 10⁹/L with bleeding requiring medical intervention or for \> 3 days. * Grade 4 anemia. * Any Grade 2-3 ophthalmologic AE not resolving within 7 days. * Any Grade 4 ophthalmologic AE. * Any Grade 4 laboratory value. * Any Grade 3 laboratory values that are not of clinical significance according to investigator and Sponsor agreement if they do not resolve within 72 hours. * Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≥ 3× upper limit of normal (ULN) and concurrent total bilirubin ≥ 2× ULN not related to liver involvement with cancer. * Any non-hematological AE ≥ Grade 3 (except nausea, vomiting, and diarrhea). * Grade 3 nausea, vomiting or diarrhea not resolving with supportive care in 72 hours. * Grade 4 nausea, vomiting or diarrhea.
| Participants | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | 0 | 0 |
Treatment-emergent adverse events are defined as adverse events (AEs) that started or worsened between the start of study drug and 28 days after permanent discontinuation of study drug. A serious AE is defined as any untoward medical occurrence that at any dose: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability or incapacity; * Was a congenital anomaly or birth defect. The investigator assessed the causality/relationship between the study treatment and each AE, and assessed the severity of each AE according to the guidelines provided in NCI-CTCAE, version 5.0 on a scale from mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death due to the AE (Grade 5). Ocular events associated with symptomatic corneal involvement and symptomatic and asymptomatic retinal involvement were events of special interest in this study.
| Participants | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 |
|---|---|---|
| Any treatment-emergent adverse event (TEAE) | 3 | 9 |
| TEAE with Grade ≥ 3 | 1 | 6 |
| TEAE related to any study drug | 3 | 9 |
| TEAE related to bemarituzumab | 2 | 5 |
| TEAE related to any agent of mFOLFOX6 | 3 | 9 |
| TEAE with Grade ≥ 3 related to any study drug | 1 | 4 |
| Serious adverse event (SAE) | 0 | 4 |
| SAE related to any study drug | 0 | 1 |
| SAE related to bemarituzumab | 0 | 0 |
| SAE related to any agent of mFOLFOX6 | 0 | 1 |
| TEAE of special interest: corneal/retina | 0 | 4 |
| TEAE of special interest: corneal/retina related to bemarituzumab | 0 | 4 |
| TEAE of special interest: corneal/retina leading to discontinuation of bemarituzumab | 0 | 2 |
| TEAE leading to discontinuation of bemarituzumab | 0 | 4 |
| TEAE leading to discontinuation of any agent of mFOLFOX6 | 0 | 4 |
| TEAE leading to dose reduction of bemarituzumab | 1 | 0 |
| TEAE leading to dose reduction of any agent of mFOLFOX6 | 1 | 5 |
| TEAE leading to death (Grade 5) | 0 | 0 |
| µg/mL | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 |
|---|---|---|
| Cycle 1 | 119 ± 8.52 | 329 ± 60.3 |
| Cycle 2 | 123 ± 13.8 | 377 ± 82.8 |
| µg/mL | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 |
|---|---|---|
| Cycle 1 | 16.5 ± 8.80 | 118 ± 25.1 |
| Cycle 2 | 25.6 ± 10.6 | 131 ± 55.3 |
Area under the observed concentration-time curve from the time of dosing to Day 14 (0-336h) calculated by log-linear trapezoidal approximation.
| μg*day/mL | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 |
|---|---|---|
| Area Under the Observed Concentration-time Curve From the Time of Dosing to Day 14 (AUC0-14) | 556 ± 232 | 2350 ± 394 |
| days | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 |
|---|---|---|
| Terminal Half-life (t1/2) of Bemarituzumab | 8.35 ± 3.36 | 4.23 ± 0.447 |
Postbaseline treatment induced antidrug antibody (ADA) positive is defined as participants with * ADA negative at baseline and ADA positive at any postbaseline timepoint, or * ADA positive at baseline and ADA positive with titer of at least 4-fold of the baseline titer at one or more postbaseline timepoint.
| Participants | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 |
|---|---|---|
| Number of Participants With Treatment Induced Anti-bemarituzumab Antibodies | 0 | 0 |
Collected over All-cause mortality: From enrollment to end of study; median (min, max) time on study was 19.4 (13.9, 22.4) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 28.6 (4.3, 49.6) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group. Adverse Events: From first dose of any study drug to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 19.4 (4.0, 35.4) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bemarituzumab 6 mg/kg + mFOLFOX6 | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Bemarituzumab 15 mg/kg + mFOLFOX6 | 2/9 (22.2%) | 4/9 (44.4%) | 9/9 (100%) |
| Event | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 |
|---|---|---|
| Oesophageal varices haemorrhageGastrointestinal disorders | 0/3 | 1/9 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 0/3 | 1/9 |
| Septic shockInfections and infestations | 0/3 | 1/9 |
| Failure to thriveMetabolism and nutrition disorders | 0/3 | 1/9 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/3 | 1/9 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/3 | 1/9 |
| Event | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 |
|---|---|---|
| NauseaGastrointestinal disorders | 3/3 | 4/9 |
| FatigueGeneral disorders | 1/3 | 8/9 |
| DiarrhoeaGastrointestinal disorders | 2/3 | 4/9 |
| StomatitisGastrointestinal disorders | 2/3 | 3/9 |
| Decreased appetiteMetabolism and nutrition disorders | 2/3 | 4/9 |
| VomitingGastrointestinal disorders | 1/3 | 4/9 |
| AnaemiaBlood and lymphatic system disorders | 0/3 | 3/9 |
| NeutropeniaBlood and lymphatic system disorders | 0/3 | 3/9 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/3 | 3/9 |
| BlepharospasmEye disorders | 1/3 | 0/9 |
| Age, Continuous(years) | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 | Total |
|---|---|---|---|
| Mean | 64.7 ± 21.46 | 62.3 ± 16.45 | 62.9 ± 16.78 |
| Age, Customized(Participants) | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 | Total |
|---|---|---|---|
| < 65 years | 1 | 5 | 6 |
| >=65 years | 2 | 4 | 6 |
| Sex: Female, Male(Participants) | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 1 | 9 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 4 |
| Not Hispanic or Latino | 1 | 7 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 | Total |
|---|---|---|---|
| Asian | 0 | 1 | 1 |
| Black or African American | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| American Indian or Alaska Native | 0 | 0 | 0 |
| White | 2 | 7 | 9 |
| Other | 0 | 1 | 1 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants) | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 | Total |
|---|---|---|---|
| 0 (Fully active) | 0 | 6 | 6 |
| 1 (Restricted activity but ambulatory) | 3 | 3 | 6 |
| Anti-Cancer Treatment Prior to Enrollment(Participants) | Bemarituzumab 6 mg/kg + mFOLFOX6 | Bemarituzumab 15 mg/kg + mFOLFOX6 | Total |
|---|---|---|---|
| Yes | 2 | 7 | 9 |
| No | 1 | 2 | 3 |
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Studies of the drug tested here: Bemarituzumab
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