Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2025-11-17
29
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if ivonescimab can help to control endocrine-refractory HR+ HER2- and/or TN mILC.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older.
- Confirmed invasive lobular cancer with negative E-cadherin staining.
- Estrogen receptor positive (>1%) or negative, progesterone receptor positive or negative, and HER2-negative.
- Willingness to undergo biopsy if tumor is safely accessible.
- If estrogen receptor positive, must be endocrine refractory and have received at least one line of endocrine therapy.
- Prior chemotherapy, antibody-drug conjugates, mTOR inhibitor, and/or PI3K treatments allowed but no more than 2 chemotherapy agents or ADCs in metastatic setting.
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Presence of measurable disease or at least one predominantly lytic bone lesion.
- Adequate hematology, kidney, liver, and coagulation function as specified.
- Stable or declining hepatitis B DNA levels on antiviral therapy if active hepatitis B.
- Treated brain metastases allowed if no progression and corticosteroids stopped or on physiologic replacement.
- Prior or concurrent malignancies allowed if not interfering with study.
- Women of child-bearing potential and men must agree to effective contraception during and 30 days after treatment.
- Negative pregnancy test on day of first dose for women of child-bearing potential.
- Ability to understand and sign informed consent.
You will not qualify if you...
- Chemotherapy or radiotherapy within 4 weeks before study entry.
- Receiving other investigational agents.
- Major surgery or serious trauma within 4 weeks before treatment or planned within 4 weeks after first dose.
- Symptomatic central nervous system metastases or CNS metastases with hemorrhage.
- History of bleeding disorders or clinically significant bleeding within 4 weeks before study.
- Unstable or uncontrolled hypertension.
- Live vaccine within 4 weeks before or planned during study.
- Severe infection or active infection requiring systemic therapy within 2 weeks before study.
- Pre-existing peripheral neuropathy grade 2 or higher.
- Uncontrolled pleural, pericardial effusions, or ascites.
- History or current interstitial lung disease or inflammatory bowel disease.
- Active autoimmune or lung disease requiring systemic therapy within 2 years, with some exceptions.
- Significant cardiac disease or unstable vascular disease within 12 months before study.
- History of severe gastrointestinal conditions or events within specified time frames.
- Radiographic evidence of major blood vessel invasion or risk of fistula formation.
- Known allergy to study drug components or severe hypersensitivity to monoclonal antibodies.
- Psychiatric or social conditions limiting study compliance.
- Pregnant or breastfeeding women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jason Mouabbi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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