A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With… (NCT05322577) | Clinical Trial Compass
TerminatedPhase 1/2
A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.
Stopped: Sponsor Decision
United States, Japan, Singapore72 participantsStarted 2022-05-17
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 great…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — do you know why it was stopped, and does that affect whether bemarituzumab combined with other treatments is still being studied anywhere I might be eligible for?
2Since this was a Phase 1/Phase 2 trial, the early part was mainly focused on finding safe doses rather than proving the treatment works — what does that mean for how much we actually know about the risks and benefits of bemarituzumab for my specific cancer?
3The trial was measuring objective response rates in Part 2, but it was terminated before completing — is there any published or shared data from this study that you could review to help inform my treatment options?
4Given that this trial is no longer enrolling, what standard first-line treatments are available for advanced gastric or gastroesophageal junction cancer that we should be considering right now instead?
5Are there other active clinical trials studying bemarituzumab or similar FGFR2b-targeting approaches that might be worth discussing as an alternative to standard therapy for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Timeframe: Day 1 up to Day 21
2
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)
3
Part 2: Objective Response (OR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)