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NCT Number: NCT05322577

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fujita Health University Hospital, Toyoake-shi, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bemarituzumab

Drug

Intravenous (IV) infusion

Capox

Drug

CAPOX administered as a combination of oxaliplatin as an IV infusion and capecitabine orally as tablets.

SOX

Drug

SOX administered as a combination of oxaliplatin as an IV infusion and S-1 orally.

Nivolumab

Drug

IV infusion.

Primary outcomes

  1. Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT)

    Time frame: Day 1 up to Day 21

  2. Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

    Time frame: Day 1 to end of treatment (up to approximately 1 year)

  3. Part 2: Objective Response (OR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Time frame: Up to 30 Months

Secondary outcomes

  1. Part 1: Area Under the Concentration-time Curve (AUC) of Bemarituzumab

    Time frame: Day 1 to end of treatment (up to approximately 1 year)

  2. Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab

    Time frame: Day 1 to end of treatment (up to approximately 1 year))

  3. Part 1: 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)

  4. Part 1: OR per RECIST v1.1

    Time frame: Up to 2 years

  5. Part 1: Duration of Response (DoR) per RECIST v1.1

    Time frame: Up to 2 years

  6. Part 1: Disease Control Rate (DCR)

    Time frame: Up to 2 years

  7. Part 1: Progression-free Survival (PFS) per RECIST v1.1

    Time frame: Up to 2 years

  8. Part 1: Overall Survival (OS)

    Time frame: Up to 2 years

  9. Part 2: Number of Participants Who Experience TEAEs

    Time frame: Up to 30 months

  10. Part 2: DoR per RECIST v1.1

    Time frame: Up to 30 months

  11. Part 2: Time to Response (TTR) per RECIST v1.1

    Time frame: Up to 30 months

  12. Part 2: Disease Control (DC) per RECIST v1.1

    Time frame: Up to 30 months

  13. Part 2: PFS per RECIST v1.1

    Time frame: Up to 30 months

  14. Part 2: OS

    Time frame: Up to 30 months

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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).

Acronym: FORTITUDE-103

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 12, 2022
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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