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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing ATRC-101, an antibody derived from a naturally occurring human antibody, for safety, tolerability, PK, and biological activity when administered every 2 weeks or every 3 weeks as a monotherapy or in combination with other anticancer agents.
Who is the study for?
Adults with certain advanced cancers (like breast, lung, colorectal, ovarian cancer or melanoma) that can't be removed by surgery or have spread and don't respond to standard treatments. They must have measurable disease and adequate organ function. Women who can bear children and men with partners of this potential must use effective birth control.Check my eligibility
What is being tested?
ATRC-101 is being tested alone or with other cancer drugs (Pembrolizumab/PLD). This trial checks its safety, how the body handles it, and if it works against cancer when given every 2 or 3 weeks. It's an early-phase study where everyone gets the experimental treatment.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions which could happen during drug administration, fatigue, blood disorders like changes in cell counts leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Area under the plasma concentration-time curve from zero to the last measurable concentration [AUC(0-t)] of ATRC-101
Distribution of tumor-infiltrating CD8+ lymphocytes (TILs) in tumor biopsy specimens at baseline and during treatment
Elimination half-life (t1/2) of ATRC-101
+6 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: ATRC-101 Q3W + PembrolizumabExperimental Treatment2 Interventions
Pembrolizumab 200mg IV Q3W or 400mg IV Q6W
Group II: ATRC-101 Q3WExperimental Treatment1 Intervention
Group III: ATRC-101 Q2W + Pegylated liposomal doxorubicin (PLD)Experimental Treatment2 Interventions
PLD 40mg/m^2 IV Run-in period of 28 days, and then 40mg/m^2 IV Q4W
Group IV: ATRC-101 Q2WExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Pegylated liposomal doxorubicin (PLD)
2015
Completed Phase 3
~640
Find a Location
Who is running the clinical trial?
Atreca, Inc.Lead Sponsor
Jonathan Benjamin, MD, PhDStudy DirectorAtreca, Inc.
Sudha Khurana, PhDStudy DirectorAtreca, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have certain types of advanced cancers and have already received treatment with anti-PD-1 or anti-PD-L1 drugs.You have a measurable disease that can be seen on imaging scans, as determined by the local doctor or radiologist.Your disease can be treated with a local therapy that aims to cure it.You have had a different type of cancer in the past 5 years, except if it was cured and has a high survival rate.You currently have or have had a specific type of nervous system disorder related to cancer.You have a positive test for Hepatitis B, or you have Hepatitis B antibodies and a high amount of the virus in your blood.You have had to take medicine for an autoimmune disease in the past 2 years.You have had a transplant using cells or organs from another person.You had severe side effects from immunotherapy before joining the study.You are currently experiencing serious side effects from a previous cancer treatment, unless there are specific exceptions.You have experienced a significant drop in your heart's ejection fraction due to medication in the past.You have a positive hepatitis C antibody test and a certain level of the hepatitis C virus in your blood.You have active, symptomatic, or untreated cancer that has spread to the brain, or you have been receiving increasing doses of corticosteroids for brain cancer in the past 2 weeks.You have received a certain amount of a type of chemotherapy called PLD or doxorubicin in the past.You have had a severe reaction to receiving antibody treatment in the past.You have advanced ovarian, fallopian tube, or peritoneal cancer that hasn't responded to platinum-based chemotherapy, or you have breast cancer that hasn't responded to other standard treatments.You have already received ATRC-101 treatment before.You have a specific type of lung cancer with certain genetic changes in the tumor.Cancer has come back in the brain only.You have lung disease or lung inflammation that is not caused by an infection.You are currently experiencing side effects from a previous treatment that affect your immune system, or you have been taking corticosteroids for a previous side effect for at least 30 days.You have been diagnosed with certain types of advanced cancer and have received or are receiving specific immunotherapy treatment.If you have a specific gene mutation in your melanoma, you must have already been treated with certain medications.You have non-small cell lung cancer and have not received platinum-based therapy, unless your doctor said it was not safe for you.You need to have a recent tissue sample from a previous cancer treatment.Your organs and bone marrow are working well, as shown by specific lab tests.You must have a good ability to do daily activities and take care of yourself.You have advanced ovarian, fallopian tube, or peritoneal cancer that did not respond well to platinum-based chemotherapy, or you have breast cancer that did not respond well to other standard treatments.You have been diagnosed with advanced breast cancer, lung cancer, colon cancer, ovarian cancer, or acral melanoma that cannot be removed with surgery, and has not responded to standard treatment or for which there is no standard treatment available.You have HIV and have had a serious infection in the past year, or your CD4+ T cell count is very low.
Research Study Groups:
This trial has the following groups:- Group 1: ATRC-101 Q3W
- Group 2: ATRC-101 Q2W + Pegylated liposomal doxorubicin (PLD)
- Group 3: ATRC-101 Q2W
- Group 4: ATRC-101 Q3W + Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Esophageal Cancer Patient Testimony for trial: Trial Name: NCT04244552 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the conditions that ATRC-101 is meant to alleviate?
"ATRC-101 is an investigational medication that has the potential to treat patients with unresectable melanoma, microsatellite instability high, and neuroblastoma (nb)."
Answered by AI
Is there a potential for abuse with ATRC-101?
"ATRC-101 has only been trialled in Phase 1 clinical trials, so there is limited evidence to support its safety."
Answered by AI
Is this the first time that ATRC-101 has been tested in a clinical setting?
"ATRC-101 was first trialled in 1997 at Spectrum Health Hospital. So far, there have been a total of 916 completed clinical trials. Right now, there are 1358 active studies, a number of which are taking place in Oklahoma City, Oklahoma."
Answered by AI
Is this clinical trial running in more than one place?
"The research teams conducting this study are based in the Stephenson Cancer Center, University of Oklahoma Health Sciences Center in Oklahoma City, Oklahoma, Massachusetts General Hospital in Boston, Massachusetts, and Mayo Clinic in Rochester, Minnesota. There are also 13 other active locations."
Answered by AI
Do we have room for more study participants?
"That is correct, the trial is still recruiting patients. The clinicaltrials.gov website indicates that the trial was first posted on February 11th, 2020 and was last updated September 28th, 2020. There are 240 patients enrolled at 13 locations."
Answered by AI
Is this research project newly conceived?
"ATRC-101 has been subject to 1358 clinical trials since 1997, when the first Phase 3 drug approval trial was completed. These trials have taken place across 72 countries and 3391 cities."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
What site did they apply to?
Vanderbilt University 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?
To find something that possibly may prolong my years of life.
PatientReceived 2+ prior treatments
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