What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly immunotherapies like CDX-301 and CDX-1140, can have a range of side effects. These may include immune-related adverse events such as fatigue, skin reactions (e.g., rash, pruritus), gastrointestinal issues (e.g., diarrhea, nausea), and flu-like symptoms (e.g., fever, chills). More severe but less common side effects can include pneumonitis, hepatitis, endocrinopathies, and colitis. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of breast cancer. One notable example is trastuzumab emtansine (T-DM1), which is used for HER2-positive advanced breast cancer. While specific approvals for dendritic cell growth factors like CDX-301 and CD40 agonists like CDX-1140 are not mentioned, the field of immunotherapy in breast cancer is expanding, with ongoing research into various immune-modulating agents. These treatments aim to enhance the body's immune response to target and control cancer cells more effectively.

What other types of research exist?

Promising novel alternatives to CDX-301 and CDX-1140 for breast cancer patients include: 1) Pembrolizumab (Keytruda), an immune checkpoint inhibitor targeting PD-1, which has shown efficacy in various cancers including breast cancer. 2) Atezolizumab (Tecentriq), another immune checkpoint inhibitor targeting PD-L1, approved for use in combination with nab-paclitaxel for PD-L1-positive triple-negative breast cancer. 3) Sacituzumab govitecan (Trodelvy), an antibody-drug conjugate targeting Trop-2, approved for metastatic triple-negative breast cancer. These therapies represent significant advancements in the treatment of breast cancer and offer new options for patients.

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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.

Must not have

Any kinase inhibitors within 2 weeks prior to the first dose of study treatment.

Prior anthracycline therapy with a cumulative doxorubicin-equivalent dose greater than 240 mg/m2.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new combination of two immune-boosting drugs and a chemotherapy drug in patients with hard-to-treat breast cancer. The goal is to see if this combination is safe and effective at controlling the 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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken any kinase inhibitors in the last 2 weeks.

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I have received a high dose of a specific chemotherapy drug.

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I do not have an active infection needing treatment, HIV, or hepatitis B/C.

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I have had or currently have lung inflammation not caused by an infection.

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I haven't had chemotherapy in the last 3 weeks or within its half-life period before starting the study treatment.

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I have had acute myeloid leukemia or my tumor has a Flt3 mutation.

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I am not pregnant or nursing, and I have a negative pregnancy test.

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I have brain metastases that haven't been treated.

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I haven't taken immunosuppressants or steroids in the last 4 weeks.

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I have been treated with anthracycline for cancer that has spread.

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I have not been treated with anti-CD40 antibody or rhuFlt3L products.

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I have not had major surgery in the last 4 weeks.

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I haven't had any type of radiation therapy in the last 2 to 8 weeks.

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I've been cancer-free for 3 years, except for minor skin cancers or in situ cancers.

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My cancer got worse on anthracycline therapy or within 6 months after stopping it.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Anti-tumor immune response by on-treatment CD8 T cell infiltrate

Body Weight Changes

Pharmacotherapy

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment 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 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 2

~160

CDX-301

2017

Completed Phase 1

~170

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include chemotherapy, hormone therapy, targeted therapy, and immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while hormone therapy blocks hormones that fuel certain types of breast cancer. Targeted therapy focuses on specific molecules involved in cancer growth. Immunotherapy, such as the treatments being studied with CDX-301 and CDX-1140, leverages the body's immune system to fight cancer. CDX-301 enhances dendritic cell function, improving antigen presentation and T-cell activation, while CDX-1140 activates the CD40 receptor, boosting T-cell responses. These immunotherapies are significant for breast cancer patients as they offer a more precise and potentially more effective way to combat cancer by enhancing the body's natural defenses.

Clinical Development of the E75 Vaccine in Breast Cancer.