Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05029999

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

Metastatic Triple Negative Breast Cancer Clinical Trial

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

Clinical Trial 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 negative breast cancer, and to determine a safe dose and treatment schedule of the three drugs. This research study will also test how these treatments improve your body's immune response against the cancer.

Clinical Trial Description

The immunotherapy drugs CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment PLD work by kickstarting the immune response against cancer cells. CDX-301 increases the antigen presenting immune cells needed to kickstart the immune response, CDX-1140 activates these cells, and chemotherapy helps release antigens from the cancer cells to train these antigen presenting immune cells to recognize the cancer for the immune system to attack it. Metastatic or unresectable triple negative breast cancer patients will receive this triplet combination that has been shown in preclinical studies to be more effective than the individual treatments or doublet combinations. To understand how the immunotherapies are working, some patients will receive the immunotherapy or chemotherapy only for one cycle prior to receiving the full triplet combination therapy. Ultimately, all patients will receive the triplet combination to study safety and how effective this treatment is at controlling triple negative breast cancer and improving survival outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05029999
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact Meredith Carter, MS
Phone (214) 648-7020
Email Meredith.carter@utsouthwestern.edu
Status Recruiting
Phase Phase 1
Start date April 20, 2022
Completion date April 20, 2025
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02158507 - Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative Breast Cancer N/A
Completed NCT02555657 - Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119) Phase 3
Completed NCT02834403 - L-NMMA Plus Taxane Chemotherapy in Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients Phase 1/Phase 2
Completed NCT03121352 - Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast Cancer Phase 2
Active, not recruiting NCT03330847 - To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy. Phase 2
Completed NCT03256344 - Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases Phase 1
Recruiting NCT04739670 - Evaluating the Efficacy and Safety of Bevacizumab, Carboplatin, Gemcitabine and Atezolizumab in Breast Cancer Phase 2
Withdrawn NCT01936961 - Study of Immunochemotherapy +/- Hypofractionated Radiation for Complete Response in Solid Tumors N/A
Completed NCT01238952 - Study of NK012 and Carboplatin in Solid Tumors With Dose Expansion in Triple Negative Breast Cancer Phase 1
Completed NCT03577743 - Effect of Bevacizumab in Metastatic Triple Negative Breast Cancer Phase 2
Completed NCT03411161 - S 81694 Plus Paclitaxel in Metastatic Breast Cancer Phase 1/Phase 2
Withdrawn NCT04149444 - A Study of Trifluridine/Tipiracil in Triple Negative Metastatic Breast Cancer Phase 2
Withdrawn NCT05008510 - P2 Clinical Efficacy & Safety Study of V-111 Monotherapy & Sacituzumab Govitecan-hziy/V-111 Combo Therapy for mTNBC . Phase 2
Completed NCT04111510 - Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer Phase 2
Terminated NCT03055312 - Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer Phase 3
Recruiting NCT03709446 - Leflunomide in Previously Treated Metastatic Triple Negative Cancers Phase 1/Phase 2