Back to Search Results
Terminated/Withdrawn
Sponsor ID
20210099

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

Sponsor ID
20210099
Clinicaltrials.gov ID
NCT05322577
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

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.

Additional Study Details

Phase
Phase 1/Phase 2
Product
Bemarituzumab
Type
Interventional
Masking
None (Open Label)
Enrollment
72
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: Day 1 up to Day 21

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

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

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

Timeframe: Up to 30 Months

Secondary Outcome Measures

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

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

Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab

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

Part 1: Observed Concentration at the end of a Dose Interval (Ctrough) of Bemarituzumab

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

Part 1: OR per RECIST v1.1

Timeframe: Up to 2 years

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

Timeframe: Up to 2 years

Part 1: Disease Control Rate (DCR)

Timeframe: Up to 2 years

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

Timeframe: Up to 2 years

Part 1: Overall Survival (OS)

Timeframe: Up to 2 years

Part 2: Number of Participants Who Experience TEAEs

Timeframe: Up to 30 months

Part 2: DoR per RECIST v1.1

Timeframe: Up to 30 months

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

Timeframe: Up to 30 months

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

Timeframe: Up to 30 months

Part 2: PFS per RECIST v1.1

Timeframe: Up to 30 months

Part 2: OS

Timeframe: Up to 30 months

Locations

Location
Status
Contact Us
Location
Severance Hospital Yonsei University Health System
Seoul, Republic of Korea, 03722
Status
Recruiting
Location
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Status
Recruiting
Location
St Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan, 216-8511
Status
Recruiting
Location
Ogaki Municipal Hospital
Ogaki-shi, Gifu, Japan, 503-8502
Status
Terminated
Location
Asan Medical Center
Seoul, Republic of Korea, 05505
Status
Recruiting
Location
Samsung Medical Center
Seoul, Republic of Korea, 06351
Status
Recruiting
Showing {first} - {last} of {total} Results
Study Info
Age
18 - 100 Years
Condition
  • Gastrointestinal Cancer
    • Show more
  • Esophagus Cancer
    • Sex
    All
    Trial Dates
    May 2022 - Nov 2025
    Inclusion and Exclusion 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 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.