RecruitingPhase 1NCT05029999

CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer

Phase 1 Pilot Study With Dose Expansion of Chemotherapy in Combination With CD40 Agonist and Flt3 Ligand in Metastatic HER2 Negative Breast Cancer


Sponsor

University of Texas Southwestern Medical Center

Enrollment

30 participants

Start Date

Apr 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This research study is being done to find out if the immunotherapy drugs called CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment pegylated liposomal doxorubicin (PLD, Doxil) are safe and effective at controlling the cancer in patients with metastatic triple Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer, and to determine a safe dose and treatment schedule of the three drugs. This research study will also test how your immune system responds to these treatments alone and in combination.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a novel immune-activating combination therapy for advanced (stage III or IV) HER2-negative breast cancer — meaning it is either triple-negative or hormone receptor-positive but HER2-negative. The combination includes a CD40 agonist (to activate the immune system), Flt3 ligand, and chemotherapy. **You may be eligible if...** - You are 18 or older - You have unresectable Stage III or Stage IV HER2-negative breast cancer (triple-negative or hormone receptor-positive) - Your cancer has progressed during or after your last cancer therapy - You are in reasonably good health (ECOG 0–2) with a life expectancy of at least 12 weeks **You may NOT be eligible if...** - Your cancer is HER2-positive - You have certain serious medical conditions (serious infections, autoimmune disease, prior organ transplant) - You have had brain metastases that are untreated or unstable - You have received specific prior therapies that make you ineligible per the protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPLD Chemotherapy

PLD chemotherapy will be administered 40 mg/m2 as intravenous injection once per cycle.

DRUGCDX-1140

CDX-1140 will be administered 1.5mg/kg as intravenous injection once per cycle.

DRUGCDX-301

CDX-301 will be administered 75µg/kg as subcutaneous injection daily x 5 doses per cycle for 2 cycles.


Locations(7)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Texas Oncology, P.A.

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05029999


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