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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05029999
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • PLD Chemotherapy — DRUG
    PLD chemotherapy will be administered 40 mg/m2 as intravenous injection once per cycle.
  • CDX-1140 — DRUG
    CDX-1140 will be administered 1.5mg/kg as intravenous injection once per cycle.
  • CDX-301 — DRUG
    CDX-301 will be administered 75µg/kg as subcutaneous injection daily x 5 doses per cycle for 2 cycles.

Study Details

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.

Key Dates

Start date
Apr 20, 2022
Status verified
Aug 2025
Primary completion
Apr 20, 2026
Completion
Apr 20, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    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.
  • Experimental: Cohort C
    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.

Primary Outcome Measure

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) [ Time Frame: Baseline up to 12 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637
Nan Chen, MD
[email protected]
Taylor Embry
[email protected]
773-834-8329
Johns Hopkins UniversityBaltimoreMaryland21287
Cesar A. Santa-Maria, MD,MSCI
[email protected]
410-614-1361
University of North CarolinaChapel HillNorth Carolina27599
Ana Gallegos
[email protected]
919-966-7581
Yara G Abdou, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research InstituteNashvilleTennessee37203-
Texas Oncology, P.A.DallasTexas75251-
UT Southwestern Medical CenterDallasTexas75390
Sangeetha Reddy, MD
[email protected]
Meredith Carter, MS
[email protected]
(214) 648-7020
The University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Virginia Kaklamani, MD,DSC
[email protected]

Find similar trials in Chicago, IL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Chicago Comprehensive Cancer Center· Chicago, ILJohns Hopkins University· Baltimore, MDUniversity of North Carolina· Chapel Hill, NCSarah Cannon Research Institute· Nashville, TNTexas Oncology, P.A.· Dallas, TXUT Southwestern Medical Center· Dallas, TX

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