Neoadjuvant Angiogenesis-Targeting Bispecific Chemoimmunotherapy for TNBC

Sponsor
University of Kansas Medical Center
Study ID
NCT07743632
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Commercially available
  • Docetaxel — DRUG
    Commercially available
  • Doxorubicin — DRUG
    Commercially available.
  • Cyclophosphamide — DRUG
    Commercially available.
  • Ivonescimab — DRUG
    Ivonescimab is a bispecific antibody targeting PD-1 and VEGF. Ivonescimab will be supplied for participants by Summit Therapeutics.

Study Details

This study will test the effectiveness of two standard neoadjuvant chemotherapy regimens plus an investigational drug (ivonescimab) that has dual action as both immunotherapy and therapy targeting the tumor's blood supply. This investigational drug is called ivonescimab.

Key Dates

First listed
Aug 4, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2032
Completion
Dec 31, 2033

Study Design

Enrollment
110 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Low-sTILs cohort (sTILs <30%)
    4 cycles of carboplatin AUC 6 plus docetaxel 75mg/m2 plus ivonescimab 20mg/kg every 21 days, followed by 4 cycles of doxorubicin + cyclophosphamide + ivonescimab 20mg/kg every 21 days.
  • Other: High-sTILs cohort (sTILs ≥30%)
    4 cycles of carboplatin AUC 6 plus docetaxel 75mg/m2 plus ivonescimab 20mg/kg every 21 days. Patients with lack of complete imaging response (by MRI) after 4 cycles will receive two additional cycles of carboplatin AUC 6 plus docetaxel 75mg/m2 plus ivonescimab 20mg/kg every 21 days.

Primary Outcome Measure

Pathologic complete response (pCR) rate in the breast and axilla in the two treatment arms. [ Time Frame: At time of definitive breast surgery ]

Central Contacts

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