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

NCT05029999 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PLD Chemotherapy

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

DRUG

CDX-1140

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

DRUG

CDX-301

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

Sponsors & Collaborators

  • Celldex Therapeutics

    collaborator INDUSTRY

  • Gateway for Cancer Research

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Sangeetha Reddy · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-20
Primary Completion
2026-04-20
Completion
2026-04-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05029999 on ClinicalTrials.gov