Ivonescimab for Breast Cancer

Overseen By Jason Mouabbi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Anticoagulants, Antiplatelet agents

Disqualifiers: CNS metastases, Hypertension, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 6 months

29 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ivonescimab, a new drug, can control certain types of advanced breast cancer that have not responded to hormonal treatments. The focus is on HR+ HER2- and/or TN mILC, specific subtypes of breast cancer. Participants will receive the treatment through an IV every three weeks. Individuals with invasive lobular cancer with certain hormone receptor profiles, whose cancer resists hormone therapy, might be suitable for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have had chemotherapy or radiotherapy within 4 weeks before entering the study and should not be on unstable doses of anticoagulants. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that ivonescimab is likely to be safe for humans?

Research has shown that ivonescimab, when combined with chemotherapy, yields promising results in terms of safety and effectiveness. Studies have found that this combination is generally well-tolerated, with manageable side effects, while effectively fighting tumors.

For instance, one study found that patients with triple-negative breast cancer responded well to ivonescimab combined with chemotherapy, deeming it both effective and safe. Another study showed similar results, noting that the treatment helped patients with advanced cancer by slowing the disease's progression.

These findings suggest that ivonescimab is generally safe for patients, though side effects may occur. Anyone considering joining a trial should discuss these potential side effects with their doctor to ensure this treatment is suitable for them. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Ivonescimab is unique because it targets a different mechanism in breast cancer treatment compared to standard options like chemotherapy, hormone therapy, and HER2-targeted treatments. This drug is designed to work by blocking specific proteins that help the cancer grow, potentially offering a more targeted approach. Researchers are excited about ivonescimab because it might provide a new way to fight breast cancer with possibly fewer side effects and improved effectiveness, especially for patients who don't respond well to existing therapies.

What evidence suggests that ivonescimab might be an effective treatment for breast cancer?

Studies have shown that ivonescimab yields promising results in treating certain cancers. In patients with advanced or metastatic triple-negative breast cancer, combining ivonescimab with chemotherapy allowed patients to live an average of 9.36 months without cancer progression. This treatment also achieved a high success rate, with 72.4% of patients experiencing tumor shrinkage or halted growth. Additionally, some studies reported that all patients saw their tumors shrink compared to their condition at the start of treatment. These findings suggest that ivonescimab could effectively control certain types of breast cancer. Participants in this trial will receive ivonescimab as part of the study's treatment plan. ^{3 5 6 7 8}

Who Is on the Research Team?

Jason Mouabbi, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

The IvoLoC trial is for individuals with metastatic invasive lobular carcinoma of the breast that's either hormone receptor-positive, HER2-negative, or triple-negative and has not responded to hormonal treatments. Specific eligibility criteria are not provided.

Inclusion Criteria

Unsterilized male participants having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception for the duration of the treatment period until 30 days after the last dose of ivonescimab

Participants must have the ability to understand and the willingness to sign a written informed consent document

I am willing to have a biopsy if my tumor can be safely reached.

Exclusion Criteria

I haven't had major surgery or serious injury in the last 4 weeks and don't plan any in the next 4 weeks.

I have had non-infectious pneumonia treated with steroids or have a lung condition.

Participants who are receiving any other investigational agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ivonescimab by vein over about 60 minutes on Day 1 of each 21-day cycle

6 months

1 visit every 21 days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Ivonescimab

Trial Overview This Phase II trial tests Ivonescimab's effectiveness in controlling advanced breast cancer that hasn't responded to endocrine therapy. It focuses on HR+ HER2- and/or TN subtypes of invasive lobular carcinoma.

How Is the Trial Designed?

Group I: Phase II: Treatment with Ivonescimab Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. cancernetwork.com cancernetwork.com/view/ivonescimab-chemo-combo-yields-positive-efficacy-and-safety-results-in-tnbc

Ivonescimab/Chemo Combo Yields Positive Efficacy and ... Ivonescimab with chemotherapy elicited a median progression-free survival of 9.36 months in patients with locally advanced unresectable or metastatic triple- ...

2. akesobio.com akesobio.com/en/media/akeso-news/240918-1/

ESMO 2024 | Akeso's Ivonescimab plus Chemo in First- ... Ivonescimab combination regimen demonstratedhigh efficacy in tumor response and disease control, with an objective response rate (ORR) of 72.4% ...

3. smmttx.com smmttx.com/pressrelease/promising-anti-tumor-activity-and-safety-of-ivonescimab-in-combination-therapies-in-crc-tnbc-and-hnscc-featured-at-esmo-2024-2/

Promising Anti-Tumor Activity and Safety of Ivonescimab in ... All patients experienced a reduction in their tumor burden compared to their baseline tumor assessment. The overall response rate and the ...

4. onclive.com onclive.com/view/dr-wang-on-updated-efficacy-and-safety-data-with-first-line-ivonescimab-plus-chemotherapy-in-tnbc

Dr Wang on Updated Efficacy and Safety Data With First- ... The median progression-free survival (PFS) across the full cohort was 9.36 months (95% CI, 6.24-NE), with a 9-month PFS rate of 61.3% (95% CI, ...

5. prnewswire.com prnewswire.com/news-releases/akesos-ivonescimab-plus-chemo-in-first-line-triple-negative-breast-cancer-showed-promising-preliminary-efficacy-and-good-safety-at-esmo-2024-302248727.html

Akeso's Ivonescimab plus Chemo in First-Line Triple ... Ivonescimab combination regimen demonstrated high efficacy in tumor response and disease control, with an objective response rate (ORR) of 72.4% ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)01814-3/fulltext

347MO The safety and efficacy of ivonescimab in ... Ivonescimab in combination with chemotherapy showed promising anti-tumor activity and tolerable safety as 1L treatment of TNBC.

7. smmttx.com smmttx.com/wp-content/uploads/2024/12/150207425-AK117-203-phase-2-TNBC-poster_L2.pdf

Evaluation of the Safety and Efficacy of Ivonescimab ... At the time of data cutoff, 35 patients had ≥1 post baseline tumor assessment and were included in the efficacy analysis.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07017673

NCT07017673 | Phase II Trial of Ivonescimab in ... The trial is designed to test the safety and efficacy of adding ivonescimab in patients with early TNBC undergoing neoadjuvant chemotherapy with carboplatin and ...