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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate

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

Find a Location

Who is running the clinical trial?

Elevation OncologyLead Sponsor
3 Previous Clinical Trials
295 Total Patients Enrolled

Media Library

Seribantumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04383210 — Phase 2
Bladder Cancer Research Study Groups: Cohort 2, Cohort 1, Cohort 3
Bladder Cancer Clinical Trial 2023: Seribantumab Highlights & Side Effects. Trial Name: NCT04383210 — Phase 2
Seribantumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04383210 — Phase 2
Bladder Cancer Patient Testimony for trial: Trial Name: NCT04383210 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential hazards accompany the usage of Seribantumab?

"Taking into consideration its Phase 2 status, our assessment of Seribantumab's safety is a 2. This reflects the fact that there exists some data validating this medication's security, yet none confirming its efficacy."

Answered by AI

Is this an unprecedented research endeavor?

"Since 2020, Seribantumab has been subject to scrutiny. Elevation Oncology was the first sponsor of research on this drug in 2020 and after a trial involving 75 patients it moved onto Phase 2 Drug Approval Stage. Currently, only one active medical study is assessing its efficacy and is again sponsored by Elevation Oncology."

Answered by AI

Is there still room for participants in this research?

"Affirmative. According to clinicaltrials.gov, this research endeavour is actively searching for participants and was originally posted on September 29th 2020. An update was last made on the 14th of September 2022, with 75 patients being sought from 38 different medical centres."

Answered by AI

What prior research has been completed with regards to Seribantumab?

"Seribantumab was initially studied in 2020 at St. Vincent's Hospital and has since seen 10 completed clinical trials, with a further trial actively recruiting from Appleton, Wisconsin."

Answered by AI

How widely distributed is the oversight of this research trial?

"Patients are being enrolled in this study at several sites across the country, including ThedaCare Regional Cancer Center in Appleton, Wisconsin; Montefiore Medical Center in Bronx, New york; and Pacific Shores Medical Group in Huntington Beach, California. Additionally, there are 38 other locations recruiting participants for this trial."

Answered by AI

What is the capacity for enrolment in this clinical trial?

"The study sponsor, Elevation Oncology, must recruit 75 patients that fulfill the inclusion criteria in order to activate this trial. Accordingly, recruitment will occur at ThedaCare Regional Cancer Center (Appleton, Wisconsin) and Montefiore Medical Center (Bronx, New york)."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of California - Irvine Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Currently on chemotherapy for pancreatic cancer with metastasis. Willing to try trial at this point. PET scan scheduled for end of September. Will see if progress is being made.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Covered by insurance? Costs involved?
PatientReceived 2+ prior treatments
~13 spots leftby Jan 2025