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CD40 Agonist
Immunotherapy + Chemotherapy for Triple Negative Breast Cancer
Phase 1
Recruiting
Led By Sangeetha Reddy
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Measurable disease allowing for serial assessment of at least one target lesion(s) by RECIST 1.1 criteria. Target lesions selected for tumor measurements should be those where additional treatments are not indicated or anticipated.
Among any patient enrolled in the first line treatment setting, subjects must be PD-L1 negative by 22C3 assay and not be eligible for FDA approved standard of care chemotherapy and anti-PD-1/PD-L1 combination therapy as alternative to this clinical trial.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 12 months
Awards & highlights
Study Summary
This trial is testing the safety and efficacy of two immunotherapy drugs in combination with standard chemotherapy to treat metastatic triple negative breast cancer.
Who is the study for?
This trial is for adults with metastatic triple negative breast cancer who have a life expectancy of at least 12 weeks. They should be in their first to third line of treatment and may have had up to two prior regimens. Participants must not be pregnant, agree to use contraception, and cannot have certain health conditions or treatments that would conflict with the trial.Check my eligibility
What is being tested?
The study tests if combining immunotherapy drugs CDX-301 and CDX-1140 with standard chemotherapy PLD is safe and effective against this type of breast cancer. It aims to find the right dose and schedule for these drugs while also observing how they affect the body's immune response to cancer.See study design
What are the potential side effects?
Potential side effects include reactions typical for immunotherapies such as fatigue, allergic responses, possible organ inflammation, as well as those associated with chemotherapy like nausea, hair loss, low blood counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least one cancer lesion that can be measured over time.
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My cancer is PD-L1 negative and I can't have standard FDA-approved chemotherapy.
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I am 18 years old or older.
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My breast cancer is advanced and cannot be removed by surgery.
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I am able to get out of my bed or chair and move around.
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Any side effects from my previous cancer treatments have mostly gone away.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety (tolerability) of the drug combination of CDX-1140, CDX-301 and PLD as measured by the number of participants with Dose Limiting Toxicity (DLT)
Secondary outcome measures
Anti-tumor immune response by on-treatment CD8 T cell infiltrate
Body Weight Changes
Pharmacotherapy
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort CExperimental Treatment3 Interventions
PLD chemotherapy will be administered 40 mg/m2 as intravenous injection once per cycle until toxicity or progression.
CDX-1140 will be administered 1.5mg/kg as intravenous injection once per cycle starting on cycle 2 until toxicity or progression for up to 24 months.
CDX-301 will be administered 75µg/kg as subcutaneous injection daily x 5 days cycles 2 and 3 only.
Group II: Cohort BExperimental Treatment3 Interventions
PLD chemotherapy will be administered 40 mg/m2 as intravenous injection once per cycle starting on cycle 2 until toxicity or progression.
CDX-1140 will be administered 1.5mg/kg as intravenous injection once per cycle until toxicity or progression for up to 24 months.
CDX-301 will be administered 75µg/kg as subcutaneous injection daily x 5 days cycles 1 and 2 only.
Group III: Cohort AExperimental Treatment3 Interventions
PLD chemotherapy will be administered 40 mg/m2 as intravenous injection once per cycle until toxicity or progression.
CDX-1140 will be administered 1.5mg/kg as intravenous injection once per cycle until toxicity or progression for up to 24 months.
CDX-301 will be administered 75µg/kg as subcutaneous injection daily x 5 days cycles 1 and 2 only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CDX-1140
2017
Completed Phase 1
~140
CDX-301
2017
Completed Phase 1
~170
Find a Location
Who is running the clinical trial?
Celldex TherapeuticsIndustry Sponsor
61 Previous Clinical Trials
3,905 Total Patients Enrolled
6 Trials studying Breast Cancer
463 Patients Enrolled for Breast Cancer
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,766 Total Patients Enrolled
22 Trials studying Breast Cancer
6,262 Patients Enrolled for Breast Cancer
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,525 Total Patients Enrolled
6 Trials studying Breast Cancer
351 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious heart problems or recent major heart events.I haven't taken any kinase inhibitors in the last 2 weeks.My cancer has worsened despite treatment, or I had to stop treatment due to side effects.I have at least one cancer lesion that can be measured over time.I have brain metastases that haven't been treated.I agree to have biopsies before and during treatment, from areas that haven't been irradiated and are safe to biopsy.My tumor is not PD-L1 positive, or I am not eligible for standard chemotherapy and anti-PD-1/PD-L1 therapy.I have received a high dose of a specific chemotherapy drug.I am in my 1st to 3rd treatment phase for a cancer that cannot be surgically removed.I haven't had cell-based cancer treatments in the last 12 weeks, or 2 weeks if my cancer got worse.I do not have an active infection needing treatment, HIV, or hepatitis B/C.You have signs of a recent or ongoing infection in your chest x-ray.I have had or currently have lung inflammation not caused by an infection.I haven't had chemotherapy in the last 3 weeks or within its half-life period before starting the study treatment.You have had strong allergic reactions to monoclonal antibodies in the past.I have had acute myeloid leukemia or my tumor has a Flt3 mutation.I am not pregnant or nursing, and I have a negative pregnancy test.I have not received a live vaccine in the last 30 days.I agree to use effective birth control during and for 6 months after the trial.My cancer is PD-L1 negative and I can't have standard FDA-approved chemotherapy.I am 18 years old or older.I haven't taken immunosuppressants or steroids in the last 4 weeks.I haven't needed strong medication for an autoimmune disease in the last 6 months.You are expected to live for at least 12 more weeks.I have been treated with anthracycline for cancer that has spread.I haven't had certain immune therapies in the weeks before starting the study.My breast cancer is advanced and cannot be removed by surgery.I have not been treated with anti-CD40 antibody or rhuFlt3L products.Your blood test results need to be within certain ranges for different measurements like white blood cells, platelets, and liver function.I have not had major surgery in the last 4 weeks.I haven't had any type of radiation therapy in the last 2 to 8 weeks.I've been cancer-free for 3 years, except for minor skin cancers or in situ cancers.I am able to get out of my bed or chair and move around.Any side effects from my previous cancer treatments have mostly gone away.My cancer got worse on anthracycline therapy or within 6 months after stopping it.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A
- Group 2: Cohort B
- Group 3: Cohort C
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any precedent studies of PLD Chemotherapy?
"Currently, there are 360 unique clinical trials being conducted with the goal of assessing PLD Chemotherapy. Of those active studies, 119 have reached Phase 3 in their trial process. While many of these investigations are situated in New york City, a total of 23596 distinct locations across the United States offer this treatment option."
Answered by AI
How risky is the utilization of PLD Chemotherapy for individuals?
"With only limited data on its safety and efficacy, PLD Chemotherapy received a score of 1 in our estimation."
Answered by AI
How many participants have been enrolled to this research endeavor?
"Affirmative. The clinicaltrials.gov database attests that this medical study, which was initially published on April 20th 2022, is actively enrolling patients. 45 individuals need to be recruited from one location for the trial's completion."
Answered by AI
What pathologies has Peripheral Lymphocyte Depletion chemotherapy been found to remediate?
"PLD Chemotherapy is a viable course of treatment for lymphoma and hodgkins, in addition to carcinoma, bronchogenic, neuroblastoma (nb), and sezary syndrome."
Answered by AI
What qualifications must potential participants possess in order to be accepted into this medical research?
"Applicants to this clinical trial must have been diagnosed with breast cancer and be between 18 and 99 years old. At present, 45 people are being accepted into the study."
Answered by AI
Is this trial a pioneer in its respective field?
"Currently, 360 distinct clinical trials centering around PLD Chemotherapy have been conducted in 66 different nations across 1941 cities since Alfacell's original 1997 trial. Of those 679 studies conducted over the last two decades, 300 participants were involved in Phase 3 drug testing."
Answered by AI
Is this experiment still accepting participants?
"Affirmative. Clinicaltrials.gov confirms that this clinical trial, first published on April 20th 2022, is actively searching for participants. 45 individuals must be recruited from one medical location."
Answered by AI
Is this research effort limited to those aged 70 and under?
"Patients of any age 18 and above, yet below 99 years old are eligible to join this clinical trial."
Answered by AI
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