ACTIVE_NOT_RECRUITING

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

Conditions

Gastric Cancer Gastroesophageal Junction Cancer Bemarituzumab FGFR2b Overexpression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main objectives of this study are to evaluate the safety and tolerability of bemarituzumab in combination with other anti-cancer therapies, and to evaluate the efficacy of bemarituzumab in combination with S-1 and oxaliplatin (SOX) and nivolumab as assessed by objective response.

Official Title

A Phase 1b/2 Study Evaluating the Safety, Tolerability, Efficacy, and Pharmacokinetics of Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer (FORTITUDE-103).

Quick Facts

Study Start:2022-05-17

Study Completion:2028-03-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05322577

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 for Part 1, FGFR2b overexpression positive defined as any FGFR2b 2+/3+ TC determined by centrally performed immunohistochemistry (IHC), based on tumor sample provided. * For Part 2, FGFR2b overexpression positive defined as FGFR2b ≥10% 2+/3+ TC determined by centrally performed IHC testing, 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. * For Part 2, measurable disease according to RECIST v1.1.	* 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. * History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmic corticosteroids.

Inclusion Criteria

Exclusion 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 for Part 1, FGFR2b overexpression positive defined as any FGFR2b 2+/3+ TC determined by centrally performed immunohistochemistry (IHC), based on tumor sample provided.
* For Part 2, FGFR2b overexpression positive defined as FGFR2b ≥10% 2+/3+ TC determined by centrally performed IHC testing, 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.
* For Part 2, measurable disease according to RECIST v1.1.

* 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.
* History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmic corticosteroids.

Contacts and Locations

Principal Investigator

STUDY_DIRECTOR

Amgen

Study Locations (Sites)

Northport Veterans Affairs Medical Center

Northport, New York, 11768

United States

Collaborators and Investigators

Sponsor: Amgen

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-17

Study Completion Date2028-03-12

Study Record Updates

Study Start Date2022-05-17

Study Completion Date2028-03-12

Terms related to this study

Keywords Provided by Researchers

Gastric Cancer
Gastroesophageal Junction Cancer
Bemarituzumab
FGFR2b Overexpression

Additional Relevant MeSH Terms

Gastric Cancer
Gastroesophageal Junction Cancer