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Gastrointestinal CancerPhase 1FIGHTNCT03343301

A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer

A Phase 1 study testing Bemarituzumab and Modified FOLFOX6 in people with Gastrointestinal Cancer and Gastrointestinal Cancer Metastatic, run by Five Prime Therapeutics, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bemarituzumab and Modified FOLFOX6
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
7 sitesUnited States
Study dates
30 Nov 2017to 31 Jan 2019
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Disease that is unresectable, locally advanced, or metastatic (not amendable to curative therapy)
  • Understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF) prior to any study-specific evaluation
  • Life expectancy of at least 3 months in the opinion of the investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Age ≥ 18 years at the time the ICF is signed
  • In sexually active patients (women of childbearing potential and males), willingness to use 2 effective methods of contraception, 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:
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  • Permanent sterilization (hysterectomy and/or bilateral oophorectomy, or bilateral tubal ligation with surgery, or vasectomy) at least 6 months prior to Screening
  • Women of childbearing potential who are on stable oral contraceptive therapy or intrauterine or implant device for at least 90 days prior to the study, or abstain from sexual intercourse as a way of living
  • Adequate hematological and biological function, confirmed by the following laboratory values within 96 hours prior to enrollment:
  • Bone Marrow Function
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
  • Platelets ≥ 100 × 10^9/L
  • Hemoglobin ≥ 9 g/dL
  • Hepatic Function
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 × upper limit of normal (ULN); if liver metastases, then < 5 × ULN
  • Bilirubin < 1.5 × ULN except in patients with Gilbert's disease
  • Renal Function
  • Calculated creatinine clearance using cockcroft Gault formula ≥ 50 mL/min or estimated glomerular filtrate rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥ 50 mL/min
  • International normalized ratio (INR) or prothrombin time (PT) < 1.5 x the ULN except for patients receiving anticoagulation, who must be on a stable dose of warfarin for 6 weeks prior to enrollment
  • Measurable or non-measurable, but evaluable disease using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Histologically or cytologically confirmed GI malignancy for which mFOLFOX6 is considered an appropriate treatment (e.g., gastric cancer [GC], colorectal carcinoma, pancreatic adenocarcinoma)
  • Patient must be a candidate to receive at least 2 doses of mFOLFOX6 chemotherapy

Who cannot join

  • Untreated or symptomatic central nervous system (CNS) metastases (CNS imaging not required). Patients with asymptomatic CNS metastases are eligible provided they have been clinically stable for at least 4 weeks and do not require intervention such as surgery, radiation, or any corticosteroid therapy for management of symptoms related to CNS disease
  • Impaired cardiac function or clinically significant cardiac disease, including any of the following (Criteria a through g):
  • Unstable angina pectoris ≤ 6 months prior to enrollment
  • Acute myocardial infarction ≤ 6 months prior to enrollment
  • New York Heart Association Class II-IV congestive heart failure
  • Uncontrolled hypertension (as defined as ≥ 160/90 despite optimal medical management)
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  • Uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
  • Active coronary artery disease
  • Fridericia's corrected QT interval (QTcF) ≥ 480
  • Peripheral sensory neuropathy ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
  • Active infection requiring systemic treatment or any uncontrolled infection ≤ 14 days prior to enrollment
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection
  • History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis)
  • Evidence or history of bleeding diathesis or coagulopathy
  • Radiotherapy ≤ 28 days of enrollment. Patients must be recovered from all acute radiotherapy-related toxicities. No radiopharmaceuticals (strontium, samarium) within 8 weeks of enrollment
  • Prior treatment with any selective inhibitor (e.g., AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the fibroblast growth factor (FGF)-FGFR pathway
  • Ongoing adverse effects from prior systemic treatment > CTCAE Grade 1 (with the exception of Grade 2 alopecia)
  • Participation in another therapeutic clinical study or receiving any investigational agent within 28 days of enrollment or during this clinical study
  • Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
  • Known positivity for human epidermal growth factor receptor 2 (HER2) (as defined by a positive immunohistochemistry [IHC] test of 3+ or IHC of 2+ with fluorescent in situ hybridization [FISH])
  • Major surgical procedures not permitted ≤ 28 days prior to enrollment. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before enrollment. In all cases the patient must be sufficiently recovered and stable before treatment administration
  • Women who are pregnant or breastfeeding (unless the patient is willing to interrupt breastfeeding during study treatment administration and then resume 6 months after study discontinuation); women of childbearing potential must not consider getting pregnant during the study
  • Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, psychiatric disturbance, uncontrolled intercurrent illness including arterial thrombosis, or symptomatic pulmonary embolism)
  • Presence of any other condition that may increase the risk associated with study participation, or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry in the study
  • Known allergy, hypersensitivity or contraindication to components of the FPA144 formulation including polysorbate or to platinum-containing medications, 5-FU, or leucovorin
  • History of prior malignancy, except (Criteria a through f):
  • Curatively treated non-melanoma skin malignancy
  • Cervical cancer in situ
  • Curatively treated Stage I uterine cancer
  • 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
  • Solid tumor treated curatively more than 5 years previously without evidence of recurrence

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • The University of Chicago Medical Center

    Chicago, Illinois, 90603

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Marin Cancer Care

    Greenbrae, California, 94904

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

  • Wilmont Cancer Institute

    Rochester, New York, 14642

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

About this study

Official title: FIGHT: A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase 2 Preceded by Dose Finding in Phase 1

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.

Read the detailed description

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).

Being tested
Bemarituzumab, Modified FOLFOX6
Keywords
gastrointestinal cancer
Medical subject headings
Gastrointestinal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BemarituzumabBiological

    Also called FPA144

    Administered by intravenous infusion over approximately 30 minutes

  • Modified FOLFOX6Drug

    Also called mFOLFOX6

    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.
Study groups in NCT03343301
Study groupRoleWhat they receive
Bemarituzumab 6 mg/kg + mFOLFOX6ExperimentalParticipants received 6 mg/kg bemarituzumab administered every 2 weeks (Q2W) and mFOLFOX6 chemotherapy administered Q2W until unacceptable toxicity, disease progression, or death.
Receives: Biological: Bemarituzumab; Drug: Modified FOLFOX6
Bemarituzumab 15 mg/kg + mFOLFOX6ExperimentalParticipants 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.
Receives: Biological: Bemarituzumab; Drug: Modified FOLFOX6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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.

  2. 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.

    Measured: 28 days

Secondary outcomes (6)

  1. 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.

    Measured: 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.

  2. Maximum Observed Serum Concentration (Cmax) of Bemarituzumab

    Measured: 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.

  3. Observed Serum Concentration of Bemarituzumab at the End of the Dose Interval (Ctrough)

    Measured: Cycle 1 day 14 predose for cohort 1 and day 8 predose for cohort 2; Cycle 2 day 14 predose

  4. 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.

    Measured: 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.

  5. Terminal Half-life (t1/2) of Bemarituzumab

    Measured: 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.

  6. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study start30 Nov 2017
  3. Primary completion31 Jan 2019
  4. Study completion31 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03343301
Sponsor's protocol ID
FPA144-004 Phase 1
Acronym
FIGHT
Status last verified
Feb 2024
First submitted
7 Nov 2017
Last updated
28 Feb 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bemarituzumab and Modified FOLFOX6 in people with Gastrointestinal Cancer and Gastrointestinal Cancer Metastatic, run by Five Prime Therapeutics, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-related Adverse Events ≥ Grade 2 (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03343301.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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