What side effects are associated with this type of intervention?

Common treatments for stomach cancer, including targeted therapies like bemarituzumab, often result in side effects such as nausea, vomiting, and fatigue. For instance, zolbetuximab, another targeted therapy, frequently causes nausea (61%), vomiting (50%), and fatigue (22%). Chemotherapy agents like oxaliplatin can also cause gastrointestinal disturbances and fatigue. Additionally, targeted therapies may lead to specific toxicities such as skin reactions and diarrhea, as seen with gefitinib. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

FDA-approved treatments for stomach cancer include a variety of targeted therapies and chemotherapies. Notably, ramucirumab, a VEGFR2 antagonist, has been approved for advanced gastric cancer. Other targeted therapies include trastuzumab for HER2-positive gastric cancer. While bemarituzumab targets FGFR2b, specific FDA approvals for FGFR2b-targeting drugs in stomach cancer are not detailed in the provided context. Broadly, treatments like pembrolizumab (an immune checkpoint inhibitor) and various chemotherapy regimens (e.g., FLOT) are also used in managing advanced gastric cancer.

What other types of research exist?

Promising alternatives to Bemarituzumab for stomach cancer patients include: <ol> <li>Ramucirumab combined with paclitaxel, which has shown efficacy as a second-line therapy.</li> <li></li> </ol> Perioperative ramucirumab in combination with FLOT chemotherapy, which is being evaluated in clinical trials. 3. Atezolizumab in combination with FLOT chemotherapy, which is under investigation for resectable esophagogastric adenocarcinoma. 4. Durvalumab combined with FLOT chemotherapy, which is also being assessed in clinical trials for resectable gastric and gastroesophageal junction cancer.

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Monoclonal Antibodies

Bemarituzumab + Chemotherapy for Stomach Cancer (FORTITUDE-103 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amendable to curative therapy.

Easter Cooperative Oncology Group (ECOG) performance score less than or equal to 1.

Must not have

Palliative radiotherapy within 14 days of first study treatment dose.

Peripheral sensory neuropathy greater than or equal to Grade 2.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called bemarituzumab combined with other cancer treatments (S-1, oxaliplatin, and nivolumab). It aims to see if this combination is safe and effective for treating cancer patients. The treatment works by directly attacking cancer cells and helping the immune system fight the cancer.

Who is the study for?

This trial is for adults with advanced gastric or gastroesophageal junction cancer that can't be removed by surgery. Participants must have a performance score indicating they are relatively active, provide a tumor sample, and have no prior treatments for metastatic disease. They should not have certain heart diseases, brain metastases, severe neuropathy, recent major surgery or other cancers within the last 2 years.

What is being tested?

The study tests bemarituzumab combined with chemotherapy (CAPOX or SOX) and possibly nivolumab in patients who haven't been treated before for their advanced stomach tumors. It aims to assess how safe this combination is and how well patients tolerate it.

What are the potential side effects?

Potential side effects may include reactions at the infusion site, increased risk of infection due to immune system suppression from chemotherapy and nivolumab, organ inflammation from bemarituzumab, as well as general side effects like fatigue and digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My stomach cancer cannot be surgically removed and is advanced.

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I am fully active or have some restrictions but can still take care of myself.

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I can safely receive CAPOX/SOX with or without nivolumab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received palliative radiotherapy within the last 14 days.

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I experience significant numbness or pain in my hands or feet.

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I haven't had major surgery or joined another study in the last 28 days.

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My cancer is HER2 positive.

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I have brain metastases or CNS disease that hasn't been treated or is causing symptoms.

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I have long-term eye problems.

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I have a serious heart condition.

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I have been treated with drugs targeting the FGF-FGFR pathway.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2: Bemarituzumab with SOX and Nivolumab.Experimental Treatment3 Interventions

Group II: Part 1 Cohort D: Bemarituzumab with SOX and NivolumabExperimental Treatment3 Interventions

Group III: Part 1 Cohort C: Bemarituzumab with CAPOX and NivolumabExperimental Treatment3 Interventions

Group IV: Part 1 Cohort A: Bemarituzumab with CAPOXExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SOX

2018

Completed Phase 2

~350

Bemarituzumab

2018

Completed Phase 2

~250

Nivolumab

2015

Completed Phase 3

~4010

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Stomach cancer treatments often include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy uses drugs like oxaliplatin and capecitabine to kill rapidly dividing cancer cells. Targeted therapies, such as Bemarituzumab, focus on specific molecular targets like FGFR2b, which is overexpressed in some stomach cancers, thereby inhibiting tumor growth and survival. Immunotherapy, including agents like nivolumab, enhances the body's immune response against cancer cells. These treatments are crucial for stomach cancer patients as they offer more personalized and potentially effective options, especially for those with specific genetic profiles or advanced disease stages.

Does tumor profile in gastric and gastroesophageal (GE) junction cancer justify off-label use of targeted therapy?-a narrative review.Promising novel therapies for the treatment of endometrial cancer.