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CAB-ROR2-ADC + PD-1 Inhibitor for Breast Cancer
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective.
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 have advanced lung, breast, or soft tissue cancer that cannot be surgically removed.I do not have any serious heart conditions.I have never been treated with auristatin or similar cancer drugs.You must have a disease that can be measured.I do not have HIV, active hepatitis B, or hepatitis C.I am not pregnant or breastfeeding.My advanced cancer has not responded to standard treatments, and no curative options are available to me.I do not have uncontrolled brain metastases.I have not had major surgery in the last 4 weeks.My liver is working well.My blood counts are within a healthy range.I am 18 years old or older.My kidneys are working well.I have never had a severe allergic reaction to monoclonal antibody therapy or any study drugs.I am fully active or restricted in physically strenuous activity but can do light work.You are expected to live for at least three more months.
- Group 1: Monotherapy - CAB-ROR2-ADC (BA3021) alone
- Group 2: Combination Therapy
- 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
Is enrollment for this research study still open to the public?
"Per the data on clinicaltrials.gov, this investigation is actively recruiting participants. It was initially posted in June of 2018 and updated as recently as July 2022."
What is the ultimate goal of this experiment?
"The primary aim of the trial, which will be evaluated over a period of three weeks, is to identify the Maximum Tolerated Dose (MTD). Secondary endpoints focus on pharmacokinetics and include Cmax (maximum observed concentration), immunogenicity of BA3021 through anti-drug antibody detection, and AUC (area under the concentration versus time curve)."
How many facilities are participating in this trial's implementation?
"Currently, 36 different medical facilities are recruiting participants for this trial. In addition to Buffalo, Cincinnati and Los Angeles, there are 33 other possible sites you may visit in order to participate. To reduce travel expenses it is ideal that you select the closest site near your residence."
How many participants are being enrolled for this research?
"In order to bring this clinical trial to fruition, BioAtla Inc. must recruit 420 eligible patients from sites such as Roswell Park in Buffalo and The Christ Hospital in Cincinnati."
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