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

JRCT ID: jRCT2041220013

Registered date:29/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric Cancer, Gastroesophageal Junction Cancer
• Date of first enrollment: 17/05/2022
• Target sample size: 80
• Countries of recruitment: Korea,Japan,United States,Japan,Singapore,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

- Experimental: Part 1 Cohort A: Bemarituzumab with CAPOX
Interventions:
Drug: Bemarituzumab
Drug: CAPOX

- Experimental: Part 1 Cohort C: Bemarituzumab with CAPOX and Nivolumab
Interventions:
Drug: Bemarituzumab
Drug: CAPOX
Drug: Nivolumab

- Experimental: Part 1 Cohort D: Bemarituzumab with SOX and Nivolumab
Interventions:
Drug: Bemarituzumab
Drug: SOX
Drug: Nivolumab

- Experimental: Part 2: Bemarituzumab with SOX and Nivolumab.
Interventions:
Drug: Bemarituzumab
Drug: SOX
Drug: Nivolumab

Outcome(s)

Primary Outcome

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 Outcome

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 1year) ]
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 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 100age old
• Gender: Both

Include criteria

1. Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amendable to curative therapy.
2. Ability to provide tumor sample, either archival (obtained within 6 months to joining study) or fresh biopsy.
3. 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.
4. For Part 2, FGFR2b overexpression positive defined as FGFR2b .10% 2+/3+ TC determined by centrally performed IHC testing, based on tumor sample provided.
5. Easter Cooperative Oncology Group (ECOG) performance score less than or equal to 1.
6. Measurable or non-measurable disease as long as evaluable by Response Evaluation Criteria Solid Tumors (RECIST) version1.1
7. Participant has no contradictions to CAPOX/SOX plus or minus nivolumab.
8. Adequate organ function.
9. For Part 2, measurable disease according to RECIST v1.1..

Exclude criteria

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).
2. Prior treatment with any selective inhibitor of fibroblast growth factor - fibroblast growth factor receptor (FGF-FGFR) pathway.
3. Known human epidermal growth factor receptor 2 (HER2) positive
4. Untreated or symptomatic central nervous system (CNS) disease or brain metastases.
5. Peripheral sensory neuropathy greater than or equal to Grade 2.
6. Clinically significant cardiac disease.
7. Other malignancy within the last 2 years (exceptions for definitively treated disease).
8. Chronic or systemic ophthalmological disorders.
9. Major surgery or other investigational study within 28 days of first study treatment dose.
10. Palliative radiotherapy within 14 days of first study treatment dose.
11. Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.
12. History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmic corticosteroids.

Related Information

• Primary Sponsor: Kaneda Hirokazu
• Secondary ID(s): NCT05322577