Name of Trial/NCT#: 
IvoLoC Trial: A Phase II Trial Evaluating the Efficacy of Ivonescimab in Metastatic Endocrine Refractory HR-positive HER2-negative or Triple Negative Invasive Lobular Carcinoma (NCT07229417)

Eligible patients:
Men and women age ≥ 18 years with confirmed metastatic invasive lobular carcinoma that is HR-positive/HER2-negative and endocrine refractory, or triple negative. Additional eligibility criteria can be found here.

Description of Trial/Summary:
This Phase II treatment study is evaluating ivonescimab in patients with metastatic invasive lobular carcinoma that is either endocrine-refractory HR-positive/HER2-negative or triple negative. Ivonescimab is a first-in-class bispecific antibody that targets PD1 and VEGF, making it an immunotherapy and anti-angiogenesis agent packed in one drug. Participants will receive ivonescimab by IV, and the study will assess progression-free survival, response, safety, and tolerability. Researchers will also explore biomarkers such as circulating tumor DNA, whole exome sequencing, and RNA sequencing to better understand which patients may benefit most from treatment.

Why is this study beneficial?/Important?
This study is important because it focuses specifically on metastatic invasive lobular carcinoma, an understudied subtype with limited treatment options, especially after endocrine resistance develops. In addition to evaluating a potential new therapy, the study includes detailed molecular analyses that may help identify which patients are most likely to respond. This could support more personalized treatment approaches for people living with metastatic ILC.

Principal Investigator:
Jason Mouabbi, MD

More information/Trial Contact:
Jason Mouabbi, MD
Phone: (713) 792-7676
Email: jamouabbi@mdanderson.org

Trial Location:
MD Anderson Cancer Center, Houston, Texas, USA

For more information: 

https://clinicaltrials.gov/study/NCT07229417#study-overview

Current Trial Status:
Recruiting