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Study Summary
This trial is testing the safety of a new immunotherapy drug for people with solid tumors. The drug will be given alone and in combination with another immunotherapy drug to see what the maximum tolerated dose is.
- Ovarian Cancer
- Colorectal Cancer
- Cancer
- Hemangiosarcoma
- Endometrial Cancer
- Fibrolamellar Carcinoma
- Non-Small Cell Lung Cancer
- Prostate Cancer
Eligibility Criteria
Inclusion Criteria
You will 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.Awards & Highlights
Trial Design
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- Your organs and bone marrow are working well, as shown by specific lab tests.There is enough tumor tissue collected before the first dose of the study drug for testing.You have a history of severe allergic reactions to a specific type of medication or have certain lung or immune system conditions.You have an ongoing autoimmune disease needing treatment, had a tissue or organ transplant, a current infection needing treatment, HIV, hepatitis B or C, or significant heart problems.You have a mental health or substance abuse issue that may make it hard for you to follow the study's rules, you are not able to make legal decisions for yourself, you are pregnant or breastfeeding, or you have had cancer in the past 2 years.You have a type of cancer that has spread or is very advanced, and there are no standard treatments available or the standard treatments have not worked.You need to have a detectable disease on imaging, except if you have prostate cancer.This is a requirement for specific groups of people with certain types of cancer such as angiosarcoma, hepatocellular cancer, non-small cell lung cancer, prostate cancer, and breast cancer.
- Group 1: 6-Week Combination Therapy
- Group 2: 6-Week Monotherapy
- Group 3: 3-Week Monotherapy
- 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 are the geographical locations at which this research is being conducted?
"Various medical centres across the US are enrolling patients for this trial, such as John Wayne Cancer Institute in Santa Monica and The University of Texas Health Science Centre at San Antonio. Moreover, there are an additional 14 sites participating in this clinical investigation, including HonorHealth Research Institute located in Scottsdale."
Is this study an innovative exploration of a particular topic?
"The first trials for AGEN1181, sponsored by Agenus Inc., started in 2019 and included 195 participants. Following the initial study, Phase 1 drug approval was granted to this medication. Currently there are 6 studies being conducted globally across 95 cities within 8 countries."
Has AGEN1181 attained official recognition from the FDA?
"AGEN1181's safety was given a score of 1 due to lack of clinical data supporting its efficacy and limited evidence evaluating its potential risks."
Is there any prior research surrounding AGEN1181?
"AGEN1181's initial clinical research was conducted in 2019 at Columbia University Irving Medical Center. This medication has since undergone 2 completed trials, with 6 more currently active sites - most notably in Santa Monica, California."
Is there still availability for individuals to participate in this scientific experiment?
"As recorded on clinicaltrials.gov, this medical study is presently in the recruitment phase and has been since April 1st 2019 when it was first posted. The listing was last updated on September 15th 2022."
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