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CD40 Agonist

CDX-1140 + CDX-301 + PLD Chemotherapy for Triple Negative Breast Cancer

University of Chicago Comprehensive Cancer Center, Chicago, IL
PLD Chemotherapy +2 morePhase 1RecruitingLed by Sangeetha ReddyResearch Sponsored by University of Texas Southwestern Medical Center

Study Summary

This trial is testing the safety and efficacy of two immunotherapy drugs in combination with standard chemotherapy to treat metastatic triple negative breast cancer.

Eligible Conditions
  • Metastatic Breast Cancer, Triple Negative Breast Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

3Treatment 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 BExperimental Treatment3 Interventions
PLD chemotherapy will be administered 40 mg/m2 as intravenous injection once per cycle starting on cycle 2 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.
Group III: 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 1
~140
CDX-301
2017
Completed Phase 1
~170

Find a Location

Who is running the clinical trial?

Celldex TherapeuticsIndustry Sponsor
60 Previous Clinical Trials
3,804 Total Patients Enrolled
6 Trials studying Breast Cancer
463 Patients Enrolled for Breast Cancer
University of Texas Southwestern Medical CenterLead Sponsor
1,013 Previous Clinical Trials
1,033,544 Total Patients Enrolled
22 Trials studying Breast Cancer
6,262 Patients Enrolled for Breast Cancer
Gateway for Cancer ResearchOTHER
42 Previous Clinical Trials
2,456 Total Patients Enrolled
6 Trials studying Breast Cancer
351 Patients Enrolled for Breast Cancer

Media Library

CDX-1140 (CD40 Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05029999 — Phase 1
Breast Cancer Research Study Groups: Cohort A, Cohort B, Cohort C
Breast Cancer Clinical Trial 2023: CDX-1140 Highlights & Side Effects. Trial Name: NCT05029999 — Phase 1
CDX-1140 (CD40 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05029999 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any precedent studies of PLD Chemotherapy?

"Currently, there are 360 unique clinical trials being conducted with the goal of assessing PLD Chemotherapy. Of those active studies, 119 have reached Phase 3 in their trial process. While many of these investigations are situated in New York City, a total of 23596 distinct locations across the United States offer this treatment option."

Answered by AI

How risky is the utilization of PLD Chemotherapy for individuals?

"With only limited data on its safety and efficacy, PLD Chemotherapy received a score of 1 in our estimation."

Answered by AI

How many participants have been enrolled to this research endeavor?

"Affirmative. The clinicaltrials.gov database attests that this medical study, which was initially published on April 20th 2022, is actively enrolling patients. 45 individuals need to be recruited from one location for the trial's completion."

Answered by AI

What pathologies has Peripheral Lymphocyte Depletion chemotherapy been found to remediate?

"PLD Chemotherapy is a viable course of treatment for lymphoma and hodgkins, in addition to carcinoma, bronchogenic, neuroblastomar lymphoma and hodgkins, in addition to carcinoma, bronchogenic, neuroblastoma (nb), and sezary syndrome."

Answered by AI

What qualifications must potential participants possess in order to be accepted into this medical research?

"Applicants to this clinical trial must have been diagnosed with breast cancer and be between 18 and 99 years old. At present, 45 people are being accepted into the study."

Answered by AI

Is this trial a pioneer in its respective field?

"Currently, 360 distinct clinical trials centering around PLD Chemotherapy have been conducted in 66 different nations across 1941 cities since Alfacell's original 1997 trial. Of those 679 studies conducted over the last two decades, 300 participants were involved in Phase 3 drug testing."

Answered by AI

Is this experiment still accepting participants?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, first published on April 20th 2022, is actively searching for participants. 45 individuals must be recruited from one medical location."

Answered by AI

Is this research effort limited to those aged 70 and under?

"Patients of any age 18 and above, yet below 99 years old are eligible to join this clinical trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
CD40 Agonist, Flt3 Ligand, and Chemotherapy in Triple Negative Breast Cancer
Sangeetha Reddy 2022. "CD40 Agonist, Flt3 Ligand, and Chemotherapy in Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05029999.
All > Breast Cancer Austin
~20 spots leftby Apr 2025
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