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Recruiting Phase 2 NCT07229417

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

Trial Parameters

Condition Metastatic Endocrine Refractory
Sponsor M.D. Anderson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 29
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-10-22
Completion 2027-09-30
Interventions
Ivonescimab

Brief Summary

To learn if ivonescimab can help to control endocrine-refractory HR+ HER2- and/or TN mILC.

Eligibility Criteria

Inclusion Criteria: * 18 years of age or older. * Historically confirmed invasive lobular cancer with negative E-cadherin staining by IHC. * Estrogen receptor (ER) positive (\>1%) or negative, progesterone receptor (PgR) positive or negative, and HER2-negative according to HER2 testing guidelines from the American Society of Clinical Oncology/College of American Pathologists. * Participants must be willing to undergo biopsy as required by the study if the tumor is safely accessible. * If ER+, participant must be endocrine refractory as per the treating oncologist assessment and has been exposed to at least one line of endocrine therapy prior to enrollment. * Participants who received prior chemotherapy, antibody-drug conjugates (ADCs), mTOR inhibitor and/or PI3K are eligible. o Participants should not have received more than 2 chemotherapeutic agents and/or ADCs in the metastatic setting. * Eastern Cooperative Oncology Group Performance status ≤ 1. * Participant has either measurable d

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