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Clinical Stage II Esophageal Adenocarcinoma AJCC v8Phase 1NCT07594548

Futibatinib With Paclitaxel and Ramucirumab for the Treatment of Locally Advanced or Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

A Phase 1 study testing Biospecimen Collection, Computed Tomography and Futibatinib in people with Clinical Stage II Esophageal Adenocarcinoma AJCC v8 and Clinical Stage III Esophageal Adenocarcinoma AJCC v8, run by Northwestern University at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

This phase I trial tests the safety, side effects and best dose of futibatinib with paclitaxel and ramucirumab for the treatment of patients with gastric, gastroesophageal junction or esophageal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Computed Tomography and Futibatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesUnited States
Study dates
9 Sep 2027to 9 Sep 2031
Phase
Phase 1

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

  • Patients must have histologically or cytologically confirmed locally advanced/unresectable gastric, gastroesophageal junction, or esophageal adenocarcinoma that is microsatellite stable and HER2 negative. (American Joint Committee on Cancer [AJCC] staging criteria; https://pmc.ncbi.nlm.nih.gov/articles/PMC5387145/)
  • Note: Histological or cytological test reports from external laboratories outside of Northwestern University (NU) will also be accepted
  • Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Note: Patients must have documented unresectable and/or metastatic disease on CT or MRI imaging completed prior to registration. Imaging must have been completed within 90 days prior to registration for participants with measurable disease
  • Patients must not have received more than 1 prior line of therapy in the metastatic setting.
  • Note: Patients who have received neoadjuvant or adjuvant therapy must have completed therapy a year prior to registration in this study. Exception: patients with neoadjuvant or adjuvant therapy who have progressed within 6 months
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  • Patients must be age ≥ 18 years
  • Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Leukocytes (white blood cells [WBC]) ≥ 2,000/mcL
  • Absolute neutrophil count (ANC) ≥ 1500/mcL
  • Hemoglobin (Hgb) ≥ 9 g/dL (transfusions within 1 week of registration are not allowed to meet cutoff)
  • Platelets (PLT) ≥ 100,000/mcL (transfusions within 1 week of registration are not allowed to meet cutoff)
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≤ 3 x institutional ULN (unless liver metastases are present, in which case they must be ≤ 5 x ULN)
  • Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN (unless liver metastases are present, in which case they must be ≤ 5 x ULN)
  • Creatinine ≤ 1.5 x Institutional ULN or meeting creatinine clearance (CrCl) criteria below
  • Creatinine clearance per the Cockcroft-Gault formula or 24-hour urine collection) ≥ 45 mL/min
  • Phosphate < ULN
  • International normalized ratio (INR) < 1.5
  • Patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA) within 28 days of registration.
  • Note: Random analysis of urine protein with a normal value is sufficient. If urine dipstick or routine analysis indicated proteinuria ≥ 2+, then a 24-hour urine is to be collected and demonstrate < 1000 mg of protein in 24 hours to allow participation in the study
  • For patients with a known history of human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration.
  • Please note: this lab is not a requirement for eligibility, however, if it has been completed previously as part of the patient's health care, it should be documented for eligibility
  • Patients with known history of chronic hepatitis B virus (HBV) infection must be on suppressive therapy with an undetectable viral load.
  • Please note: this lab is not a requirement for eligibility, however if it has been completed previously as part of the patient's health care, it should be documented for eligibility
  • Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with a known HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.
  • Please note: this lab is not a requirement for eligibility, however if it has been completed previously as part of the patient's health care, it should be documented for eligibility
  • Patients with treated brain metastases must not have any evidence of progression on the follow-up brain imaging after central nervous system (CNS)-directed therapy.
  • Note: All treatment for brain metastases must have been completed at least 28 days prior to registration
  • Futibatinib and other therapeutic agents used in this trial are known to be teratogenic. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from time of informed consent, for the duration of study participation, and for 3 months following completion of study drug therapy. Should a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from time of informed consent, for the duration of study participation, and 3 months after completion of study drug administration
  • Note: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy
  • Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
  • POCBP must have a negative pregnancy test prior to registration on study
  • Patients must have the ability to understand and the willingness to sign a written informed consent document and comply with the study requirements
  • Patients must have the ability to swallow, retain and absorb oral medications

Who cannot join

  • Patients with adenosquamous or mixed histology disease
  • Patients who have received/are receiving other investigational agents, or anticancer/antineoplastic therapy including chemotherapy, immunotherapy, biological response modifiers, anti-neoplastic endocrine therapy or devices concurrently or within 21 days or 5 times the half-life, whichever is shorter, prior to first dose of cycle 1
  • Patients who have previously received a FGFR inhibitor.
  • Note: Agents that are multi-kinase inhibitors are allowed
  • Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia, neuropathy and other non-significant adverse events per NCI CTCAE v 6.0
  • Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, ramucirumab, or futibatinib
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  • Patients who have major surgical procedure planned during the study or any surgery within 28 days of registration or any subcutaneous venous access device placement within 7 days prior registration
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, or who have experienced arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to registration ,should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.
  • Note: To be eligible for this trial, patients should be class 2B or better
  • History of gastrointestinal perforation and/or fistulae within 6 months prior to registration
  • History of active bleeding or significant gastrointestinal (GI) bleeding requiring intervention within 60 days prior to registration
  • History and/or current evidence of endocrine alteration of calcium-phosphorus homeostasis. History and/or current evidence of ectopic mineralization/calcification including but not limited to soft tissue, kidneys, intestine, or myocardia and lung with the exception of calcified lymph nodes and asymptomatic arterial calcification
  • Current evidence of retinal disorder/keratopathy including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, etc., confirmed by ophthalmologic examination
  • Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:
  • Hypertension that is not controlled on medication(per treating physician's discretion)
  • Ongoing or active infection requiring systemic treatment
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
  • Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or activity assessment of the investigational regimen (per treating physician's discretion)
  • Patients who are pregnant or nursing

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Study Coordinator contact

3126951301

cancer@northwestern.edu

United States2 sites

  • Northwestern University

    Chicago, Illinois, 60611

    Gladys Rodriguez, MD, (830) 352-9352, gladys.rodriguez@northwestern.edu

    Gladys Rodriguez, MD

  • Ohio State University

    Columbus, Ohio, 43210

    Shafia Raham, MD, 614 293-6529, shafia.rahman@osumc.edu

Other trials in United States

About this study

Official title: A Phase I/Ib Dose Escalation Trial of Futibatinib in Combination With Paclitaxel/Ramucirumab in Second Line Confirmed Locally Advanced/Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

This phase I trial tests the safety, side effects and best dose of futibatinib with paclitaxel and ramucirumab for the treatment of patients with gastric, gastroesophageal junction or esophageal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving futibatinib with paclitaxel and ramucirumab may be safe and tolerable in treating patients with locally advanced or unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the safety, tolerability and maximum tolerated dose (MTD) for futibatinib in combination with paclitaxel/ramucirumab in patients with confirmed locally advanced/unresectable gastric, gastroesophageal junction, or esophageal adenocarcinoma.

SECONDARY OBJECTIVES:

  1. To determine the toxicity profile of futibatinib in combination with paclitaxel/ramucirumab in patients with confirmed locally advanced/unresectable gastric, gastroesophageal junction, or esophageal adenocarcinoma using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACE) version (v) 6.

II. To evaluate the preliminary activity (overall response rate [ORR], duration of response [DoR], progression free survival [PFS], overall survival [OS]) of futibatinib in combination with paclitaxel/ramucirumab in patients with confirmed locally advanced/unresectable gastric, gastroesophageal junction, or esophageal adenocarcinoma.

EXPANSION PHASE OBJECTIVE:

  1. To evaluate the activity (ORR and DoR) of futibatinib in combination with paclitaxel/ramucirumab in patients with confirmed locally advanced/unresectable gastric, gastroesophageal junction, or esophageal adenocarcinoma.

OUTLINE: This is a dose-escalation study of futibatinib in combination with fixed-dose paclitaxel and ramucirumab followed by a dose-expansion study.

Patients receive ramucirumab intravenously (IV) over 30-60 minutes on days 1 and 15 of each cycle, paclitaxel IV over 60 minutes on days 1, 8 and 15 of each cycle, and futibatinib orally (PO) once daily (QD) on days 8-28 of cycle 1 and days 1-28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI), and optional blood and urine sample collection throughout the study.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Being tested
Biospecimen Collection, Computed Tomography, Futibatinib, Magnetic Resonance Imaging, Paclitaxel
Medical subject headings
Adenocarcinoma Of Esophagus

What participants receive

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

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood and urine sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • FutibatinibDrug

    Also called Lytgobi, TAS 120, TAS-120, TAS120

    Given PO

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • RamucirumabBiological

    Also called Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC 1121B, IMC-1121B

    Given IV

Study groups in NCT07594548
Study groupRoleWhat they receive
Treatment (futibatinib, paclitaxel, ramucirumab)ExperimentalPatients receive ramucirumab IV over 30-60 minutes on days 1 and 15 of each cycle, paclitaxel IV over 60 minutes on days 1, 8 and 15 of each cycle, and futibatinib PO QD on days 8-28 of cycle 1 and days 1-28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI, and optional blood and urine sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Futibatinib; Procedure: Magnetic Resonance Imaging; Drug: Paclitaxel; Biological: Ramucirumab

What is being measured

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

  1. Maximum tolerated dose

    Defined as the highest dose that causes dose-limiting toxicities (DLTs) in < 2 of 6 subjects. Will be estimated using the Bayesian Optimal Interval algorithm based on observed DLTs. The frequency of DLTs at each dose level will be summarized using descriptive statistics, including proportions and confidence intervals.

    Measured: From cycles 1 day 8 (start of Futibatinib) to cycle 2 day 8 (cycle length = 28 days)

  2. Recommended phase 2 dose

    Measured: Up to 2 years

Secondary outcomes (5)

  1. Incidence of adverse events

    Defined as the frequency of adverse events by type, severity (grade), timing, and attribution to [study drugs, according the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

    Measured: Up to 2 years

  2. Objective response rate

    Defined as the proportion of treated patients who experience an objective response (confirmed complete response [CR] or confirmed partial response [PR]) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be calculated with corresponding 95% confidence intervals.

    Measured: From treatment initiation until the response has been confirmed, the patient experiences disease progression, initiates subsequent anti-cancer therapy, or completes study participation, up to 2 years after completion of study treatment

  3. Duration of response (DOR)

    Response is defined as confirmed complete response or confirmed partial response per RECIST 1.1; and disease progression is defined as progressive disease per RECIST 1.1. Will be summarized using the Kaplan-Meier method, with estimates of median DOR and corresponding 95% confidence intervals.

    Measured: From the first scan showing CR or PR to disease progression or death, up to 2 years after completion of study treatment

  4. Progression free survival (PFS)

    PFS will be calculated based on the Kaplan-Meier estimates of PFS. Disease progression is defined as progressive disease per RECIST 1.1, other documented clinical or radiographical progression per physician judgement, or death due to disease.

    Measured: From treatment initiation and the earlier of the day of first documented disease progression or death, up to 2 years after completion of study treatment

  5. Overall survival (OS)

    Median OS will be calculated based on the Kaplan-Meier estimates of OS.

    Measured: From start of treatment and the date of death from any cause, up to 2 years after completion of study treatment

Timeline

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

  1. First posted18 May 2026
  2. Study start9 Sep 2027 (estimated)
  3. Primary completion9 Sep 2030 (estimated)
  4. Study completion9 Sep 2031 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07594548
Sponsor's protocol ID
NU 25I08
Other IDs
NCI-2026-03370, STU00225647, NU 25I08, P30CA060553
Status last verified
May 2026
First submitted
13 May 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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