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A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer. (FORTITUDE-103)

Primary Purpose

Gastric Cancer, Gastroesophageal Junction Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Bemarituzumab
CAPOX
SOX
Nivolumab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Gastric Cancer focused on measuring Gastric Cancer, Gastroesophageal Junction Cancer, Bemarituzumab, FGFR2b Overexpression

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amendable to curative therapy.
  • Confirmed FGFR2b overexpression by immunohistochemistry (IHC) (central testing result).
  • Easter Cooperative Oncology Group (ECOG) performance score less than or equal to 1.
  • Measurable or non-measurable disease as long as evaluable by Response Evaluation Criteria Solid Tumors (RECIST) version 1.1
  • Participant has no contradictions to CAPOX/SOX plus or minus nivolumab.
  • Adequate organ function.

Exclusion Criteria:

  • Prior treatment for metastatic or unresectable disease (Note: prior adjuvant or neo-adjuvant therapy for local disease is allowed if ended more than 6 months of 1st dose).
  • Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway.
  • Known human epidermal growth factor receptor 2 (HER2) positive
  • Untreated or symptomatic central nervous system (CNS) disease or brain metastases.
  • Peripheral sensory neuropathy greater than or equal to Grade 2.
  • Clinically significant cardiac disease.
  • Other malignancy within the last 2 years (exceptions for definitively treated disease).
  • Chronic or systemic ophthalmological disorders.
  • Major surgery or other investigational study within 28 days of first study treatment dose.
  • Palliative radiotherapy within 14 days of first study treatment dose.
  • Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.

Sites / Locations

  • Northport Veterans Affairs Medical CenterRecruiting
  • Ogaki Municipal Hospital
  • St Marianna University HospitalRecruiting
  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer CenterRecruiting
  • Shizuoka Cancer CenterRecruiting
  • National Cancer Center HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • National University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort A: Bemarituzumab with CAPOX

Cohort C: Bemarituzumab with CAPOX and Nivolumab

Cohort D: Bemarituzumab with SOX and Nivolumab

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

Secondary Outcome Measures

Area Under the Concentration-time Curve (AUC) of Bemarituzumab
Maximum Observed Concentration (Cmax) of Bemarituzumab
Observed Concentration at the end of a Dose Interval (Ctrough) of Bemarituzumab
Objective Response Rate (ORR)
Duration of Response (DoR)
Disease Control Rate (DCR)
Progression-free Survival (PFS)
Overall Survival (OS)

Full Information

First Posted
April 4, 2022
Last Updated
October 2, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT05322577
Brief Title
A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.
Acronym
FORTITUDE-103
Official Title
A Phase 1b Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer (FORTITUDE-103).
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
May 5, 2026 (Anticipated)
Study Completion Date
September 5, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The main objective of this study is to evaluate the safety and tolerability of bemarituzumab in combination with other anti-cancer therapies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastroesophageal Junction Cancer
Keywords
Gastric Cancer, Gastroesophageal Junction Cancer, Bemarituzumab, FGFR2b Overexpression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: Bemarituzumab with CAPOX
Arm Type
Experimental
Arm Title
Cohort C: Bemarituzumab with CAPOX and Nivolumab
Arm Type
Experimental
Arm Title
Cohort D: Bemarituzumab with SOX and Nivolumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bemarituzumab
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
CAPOX
Intervention Description
CAPOX administered as a combination of oxaliplatin as an IV infusion and capecitabine orally as tablets.
Intervention Type
Drug
Intervention Name(s)
SOX
Intervention Description
SOX administered as a combination of oxaliplatin as an IV infusion and S-1 orally.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
IV infusion.
Primary Outcome Measure Information:
Title
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Time Frame
Day 1 up to Day 21
Title
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Time Frame
Day 1 to end of treatment (up to approximately 1 year)
Secondary Outcome Measure Information:
Title
Area Under the Concentration-time Curve (AUC) of Bemarituzumab
Time Frame
Day 1 to end of treatment (up to approximately 1 year)
Title
Maximum Observed Concentration (Cmax) of Bemarituzumab
Time Frame
Day 1 to end of treatment (up to approximately 1 year))
Title
Observed Concentration at the end of a Dose Interval (Ctrough) of Bemarituzumab
Time Frame
Day 1 to end of treatment (up to approximately 1 year)
Title
Objective Response Rate (ORR)
Time Frame
Up to 2 years
Title
Duration of Response (DoR)
Time Frame
Up to 2 years
Title
Disease Control Rate (DCR)
Time Frame
Up to 2 years
Title
Progression-free Survival (PFS)
Time Frame
Up to 2 years
Title
Overall Survival (OS)
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amendable to curative therapy. Ability to provide tumor sample, either archival (obtained within 6 months to joining study) or fresh biopsy. For certain arms, confirmed FGFR2b overexpression by immunohistochemistry (IHC) (central testing result) based on tumor sample provided. Easter Cooperative Oncology Group (ECOG) performance score less than or equal to 1. Measurable or non-measurable disease as long as evaluable by Response Evaluation Criteria Solid Tumors (RECIST) version 1.1 Participant has no contradictions to CAPOX/SOX plus or minus nivolumab. Adequate organ function. Exclusion Criteria: Prior treatment for metastatic or unresectable disease (Note: prior adjuvant or neo-adjuvant therapy for local disease is allowed if ended more than 6 months of 1st dose). Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway. Known human epidermal growth factor receptor 2 (HER2) positive Untreated or symptomatic central nervous system (CNS) disease or brain metastases. Peripheral sensory neuropathy greater than or equal to Grade 2. Clinically significant cardiac disease. Other malignancy within the last 2 years (exceptions for definitively treated disease). Chronic or systemic ophthalmological disorders. Major surgery or other investigational study within 28 days of first study treatment dose. Palliative radiotherapy within 14 days of first study treatment dose. Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Northport Veterans Affairs Medical Center
City
Northport
State/Province
New York
ZIP/Postal Code
11768
Country
United States
Individual Site Status
Recruiting
Facility Name
Ogaki Municipal Hospital
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Individual Site Status
Terminated
Facility Name
St Marianna University Hospital
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si, Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD Sharing URL
https://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.

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