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Seribantumab for Solid Cancers
Study Summary
This trial is testing a new cancer treatment for patients with solid tumors that contain a specific gene fusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I can provide a recent or stored tumor sample for NRG1 gene fusion testing.You are not expected to live more than 3 months.I've had at least one treatment for my cancer, but it didn't work, and there are no cure options left.I can take care of myself and am up and about more than half of my waking hours.I have previously received ERBB3/HER3 targeted therapy.I have brain metastases but they are either treated and stable without steroids, or I don't have any.I am not receiving treatment for any other cancer.I have previously received treatments targeting ERBB/HER2/HER3.My cancer has an NRG1 gene fusion, confirmed by a certified lab test.I do not have serious heart conditions like recent heart attacks or unstable heart rhythms.My cancer has a specific mutation that can be targeted with treatment.I am 18 years old or older.
- Group 1: Cohort 2
- Group 2: Cohort 1
- Group 3: Cohort 3
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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)."
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