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Bifunctional Fusion Protein

Immunocytokine NHS-IL12 for Breast Cancer

Phase 1
Waitlist Available
Led By Meghan Karuturi, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is willing and able to provide written informed consent for the trial and has signed the appropriate written informed consent form, approved by the investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the performance of any trial activities
Is age >= 18 years at time of study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 years
Awards & highlights

Study Summary

This study is evaluating whether NHS-IL12, bintrafusp alfa, and radiation therapy may be a safe and effective treatment for patients with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body (metastatic).

Eligible Conditions
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs)
Recommended phase II dose (RP2D)
Secondary outcome measures
Overall survival (OS)
Percent (%) change in tumor infiltrating lymphocytes (TIL)
Progression-free survival (PFS)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (bintrafusp alfa, NHS-IL12, radiation therapy)Experimental Treatment3 Interventions
Patients receive bintrafusp alfa IV over 1 hour on days 1 and 14 and immunocytokine NHS-IL12 SC on day 14. Beginning on day 14 of cycle 1, patients undergo radiation therapy QD for up to 4 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bintrafusp alfa
Not yet FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,449 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
Meghan Karuturi, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
57 Total Patients Enrolled

Frequently Asked Questions

~0 spots leftby Mar 2025