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 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2025-0658NCI-2025-08557
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Endocrine Refractory; Triple Negative Invasive Lobular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  an average of 1 year

Study Arms (1)

Phase II: Treatment with Ivonescimab

EXPERIMENTAL

Participants found to be eligible to take part in this study, you will receive ivonescimab by vein over about 60 minutes on Day 1 of each 21-day cycle.

Drug: Ivonescimab

Interventions

Ivonescimab DRUG

Given by IV

Phase II: Treatment with Ivonescimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 disease per response evaluation criteria in solid tumors (RECIST) v1.1 criteria OR at least one predominantly lytic bone lesion must be present.
• Adequate Organ Function:
• Hematology (no blood transfusions or growth factor therapy used within 7 days of the screening CBC): i. Absolute neutrophil count (ANC) ≥ 1.0 × 109/L ii. Platelet count ≥ 100 × 109/L iii. Hemoglobin ≥ 9.0 g/dL
• Kidneys:
• Creatinine clearance (CrCL) ≥ 60 mL/min using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥60 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (adjustment by BSA is not required for eGFR). CrCL or eGFR can be determined using the calculator from the National Kidney Foundation website (www.kidney.org).
• Urine protein \< 2+ or 24 hour urine protein quantification \< 1.0 g
• Liver:

You may not qualify if:

• Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study.
• Participants who are receiving any other investigational agents.
• Major surgical procedures or serious trauma within 4 weeks prior to treatment start date or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrolment.
• Participants with symptomatic CNS metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to enrolment potential need for CNS radiation within the first cycle, or leptomeningeal disease.
• History of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to enrolment on study, including but not limited to:
• Clinically significant bleeding (e.g., coughing up ≥0.5 teaspoon of fresh blood or small blood clots). Brief or transient bleeding associated with diagnostic procedures (e.g., endoscopy or bronchoscopy) is permitted.
• Nasal bleeding /epistaxis (bloody nasal discharge is allowed)
• Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to enrolment on study is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.
• Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy
• Live vaccine or live attenuated vaccine within 4 weeks prior to planned enrolment on study, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period.
• Inactivated vaccines are permitted.
• Severe infection within 4 weeks prior to enrolment on study, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrolment on study (excluding antiviral therapy for hepatitis B or C)
• Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5
• Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic.
• Participants managed with indwelling catheters (eg, PleurX) are allowed.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

Study Officials

• Jason Mouabbi, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Mouabbi, MD

CONTACT

(713) 792-7676; jamouabbi@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2029
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

US (1)