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

Gastric Cancer Clinical Trial

— FORTITUDE-103  

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322577
• Other study ID #: 20210099
• Status: Recruiting
• Phase: Phase 1
• Start date: May 17, 2022
• Est. completion date: April 1, 2028

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 1, 2028
• Est. primary completion date: March 17, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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 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.

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastroesophageal Junction Cancer
• Stomach Neoplasms

Intervention

Drug:
• Bemarituzumab
Intravenous (IV) infusion
• CAPOX
CAPOX administered as a combination of oxaliplatin as an IV infusion and capecitabine orally as tablets.
• SOX
SOX administered as a combination of oxaliplatin as an IV infusion and S-1 orally.
• Nivolumab
IV infusion.

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	St Marianna University Hospital	Kawasaki-shi	Kanagawa
Japan	Kochi Health Sciences Center	Kochi-shi	Kochi
Japan	Gunma University Hospital	Maebashi-shi	Gunma
Japan	Ogaki Municipal Hospital	Ogaki-shi	Gifu
Japan	Okayama University Hospital	Okayama-shi	Okayama
Japan	Osaka General Medical Center	Osaka-shi	Osaka
Japan	Tohoku University Hospital	Sendai-shi	Miyagi
Japan	Dokkyo Medical University Hospital	Shimotsuga-gun	Tochigi
Japan	Shizuoka General Hospital	Shizuoka-shi	Shizuoka
Japan	Shizuoka Cancer Center	Sunto-gun	Shizuoka
Japan	Osaka Medical and Pharmaceutical University Hospital	Takatsuki-shi	Osaka
Japan	Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center	Yokohama-shi	Kanagawa
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si, Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Singapore	National University Hospital	Singapore
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United States	Northport Veterans Affairs Medical Center	Northport	New York

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Japan,  Korea, Republic of,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT)		Day 1 up to Day 21
Primary	Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)		Day 1 to end of treatment (up to approximately 1 year)
Primary	Part 2: Objective Response (OR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)		Up to 30 Months
Secondary	Part 1: Area Under the Concentration-time Curve (AUC) of Bemarituzumab		Day 1 to end of treatment (up to approximately 1 year)
Secondary	Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab		Day 1 to end of treatment (up to approximately 1 year))
Secondary	Part 1: Observed Concentration at the end of a Dose Interval (Ctrough) of Bemarituzumab		Day 1 to end of treatment (up to approximately 1 year)
Secondary	Part 1: OR per RECIST v1.1		Up to 2 years
Secondary	Part 1: Duration of Response (DoR) per RECIST v1.1		Up to 2 years
Secondary	Part 1: Disease Control Rate (DCR)		Up to 2 years
Secondary	Part 1: Progression-free Survival (PFS) per RECIST v1.1		Up to 2 years
Secondary	Part 1: Overall Survival (OS)		Up to 2 years
Secondary	Part 2: Number of Participants Who Experience TEAEs		Up to 30 months
Secondary	Part 2: DoR per RECIST v1.1		Up to 30 months
Secondary	Part 2: Time to Response (TTR) per RECIST v1.1		Up to 30 months
Secondary	Part 2: Disease Control (DC) per RECIST v1.1		Up to 30 months
Secondary	Part 2: PFS per RECIST v1.1		Up to 30 months
Secondary	Part 2: OS		Up to 30 months

External Links

•   AmgenTrials clinical trials website