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NCT07229417PHASE2RECRUITING

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

Sponsor: M.D. Anderson Cancer Center

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
Metastatic Endocrine Refractory, Triple Negative Invasive Lobular Carcinoma
Interventions
Ivonescimab
Enrollment
29 participants
Primary completion
Sep 2027
Study completion
Sep 2029
First posted
Nov 2025
Last updated
Nov 2025

Primary Endpoints (CT.gov)

Safety and adverse events (AEs)

Time frame: an average of 1 year

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 measurab

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov