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Monoclonal Antibodies

Seribantumab for Solid Cancers

Phase 2

Waitlist Available

Research Sponsored by Elevation Oncology

Eligibility Criteria Checklist

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

Must have

Locally-advanced or metastatic solid tumor with an NRG1 gene fusion identified through molecular assays, such as PCR, NGS (RNA or DNA) or FISH, by a CLIA-certified or similarly accredited laboratory

Availability of fresh or archived FFPE tumor sample to be submitted to a central laboratory for confirmation of NRG1 gene fusion status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment for patients with solid tumors that contain a specific gene fusion.

Who is the study for?

Adults with advanced solid tumors that have a specific genetic change called NRG1 fusion can join this trial. They must be over 18, in fair to good health (ECOG PS 0-2), and have tried at least one standard treatment without success. Participants need to use effective birth control and cannot have symptomatic brain metastases or other active cancers needing treatment.

What is being tested?

The study is testing Seribantumab, an investigational drug for various advanced cancers with the NRG1 gene fusion. It's an open-label Phase 2 trial where all participants receive the drug, aiming to see its effect on tumor size and patient response.

What are the potential side effects?

While not specified here, similar drugs often cause side effects like allergic reactions, fatigue, nausea, skin rash or itching. Since Seribantumab targets certain proteins involved in cancer growth, it may also affect normal cells causing unexpected symptoms.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has an NRG1 gene fusion, confirmed by a certified lab test.

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I can provide a recent or stored tumor sample for NRG1 gene fusion testing.

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I've had at least one treatment for my cancer, but it didn't work, and there are no cure options left.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment1 Intervention

Up to 10 adult advanced solid tumor patients harboring NRG1 gene fusions lacking an EGF-like domain, who have received prior standard treatment, which may have included prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.

Group II: Cohort 2Experimental Treatment1 Intervention

Up to 10 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, including prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.

Group III: Cohort 1Experimental Treatment1 Intervention

A minimum of 55 adult advanced solid tumor patients harboring NRG1 gene fusions, who have received prior standard treatment, excluding prior ERBB-directed therapy. Seribantumab 1-h IV infusion at various doses once weekly, every 2 weeks and every 3 weeks, during the induction, consolidation and maintenance dosing phases, respectively.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Seribantumab

2021

Completed Phase 2

~10

0 / 9Eligibility criteria met