Avasopasem for Breast Cancer

Overseen By Kate Lathrop, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: The University of Texas Health Science Center at San Antonio

Must be taking: Ribociclib, Abemaciclib, Aromatase inhibitors

Must not be taking: Palbociclib, Tamoxifen, Nitrates, PDE5 inhibitors

Disqualifiers: Untreated brain metastases, CYP3A4 use, others

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

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding avasopasem, a potential new drug, to current treatments can improve outcomes for women with a specific type of breast cancer that has spread and is hormone receptor positive. The focus is on those whose cancer has continued to grow despite using a CDK 4/6 inhibitor, such as ribociclib or abemaciclib, along with hormonal therapy. Women with hormone receptor positive, HER2 negative breast cancer that has progressed on these treatments might be suitable candidates for this study. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use certain drugs like potent CYP3A4 inhibitors or inducers, and you must stop them two weeks before joining the trial. You also need to be on specific cancer treatments like ribociclib or abemaciclib and certain hormonal therapies.

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

Research has shown that avasopasem has been tested in other situations without causing major treatment-specific side effects. When combined with certain types of radiation therapy, avasopasem did not exacerbate the usual side effects of radiation, indicating that it is generally well-tolerated. However, as this study remains in the early stages, more information is needed to fully understand its safety when used with other cancer treatments. Prospective participants should consult their doctor to discuss all the details before joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for hormone receptor-positive breast cancer, which typically involve cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors and aromatase inhibitors, Avasopasem offers a novel approach. Researchers are excited about Avasopasem because it introduces a new active ingredient, GC4419, which is believed to target oxidative stress in cancer cells. This can potentially enhance the effectiveness of existing therapies, offering hope to those whose cancer has progressed despite standard treatment. By addressing a different aspect of cancer cell survival, Avasopasem may provide a fresh avenue for controlling metastatic breast cancer.

What evidence suggests that avasopasem might be an effective treatment for metastatic hormone receptor positive breast cancer?

Research has shown that avasopasem may help treat severe oral mucositis, a painful mouth condition, in patients receiving radiation for head and neck cancer. This suggests it might protect healthy cells from damage during cancer treatments. In this trial, researchers are investigating avasopasem for its potential to enhance the effectiveness of current treatments, such as CDK 4/6 inhibitors and hormonal therapies, in patients with hormone receptor-positive metastatic breast cancer. While specific evidence for breast cancer is still being gathered, its protective effects in other cancers suggest potential usefulness here as well. ^{1 2 3 6 7}

Who Is on the Research Team?

Kate Lathrop, MD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for women with metastatic hormone receptor positive breast cancer that has worsened despite treatment with a CDK 4/6 inhibitor and hormonal therapy. Specific eligibility criteria are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

FOCBP who engage in intercourse must agree to use adequate contraception

I am 18 years old or older.

Negative serum pregnancy test within 7 days prior to registration

Exclusion Criteria

I have not had systemic therapy for cancer that has spread, except hormone therapy with a CDK 4/6 inhibitor.

I have new or worsening brain tumors that haven't been treated.

I haven't taken strong CYP3A4 drugs in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Avasopasem in combination with a CDK 4/6 inhibitor and hormonal therapy. Each treatment cycle is 28 days, with tumor assessments every two cycles.

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Avasopasem

Trial Overview

The study tests the safety and effectiveness of avasopasem when added to ongoing CDK 4/6 inhibitor and hormonal therapy in treating advanced breast cancer. It aims to see if avasopasem can enhance current treatments.

How Is the Trial Designed?

Group I: Metastatic Hormone Receptor Positive Breast Cancer Experimental Treatment 1 Intervention

This study is investigating the addition of a novel agent, Avasopasem (or GC4419), in patients with hormonal receptor positive (HR+) metastatic breast cancer with progression while on treatment with a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor and an aromatase inhibitor.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07137871

NCT07137871 | Clinical Trial of Avasopasem in Patients ...

This study aims to evaluate the safety of avasopasem in combination with CDK 4/6 inhibitor and hormonal therapy in women with metastatic hormone receptor ...

2.

delta.larvol.com

delta.larvol.com/Products/?ProductId=8c10e0cc-647f-454a-bbe0-398133a4c22b

avasopasem (GC4419) / Galera Therap

Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal ...

3.

targetedonc.com

targetedonc.com/view/fda-rejects-nda-for-avasopasem-in-rt-induced-severe-oral-mucositis

FDA Rejects NDA for Avasopasem in RT-Induced Severe ...

Data supporting the new drug application (NDA) for avasopasem manganese are sifficent to support approval, according to the FDA.

4.

oncnursingnews.com

oncnursingnews.com/view/avasopasem-receives-priority-review-for-radiotherapy-induced-severe-oral-mucositis

Avasopasem Receives Priority Review for Radiotherapy ...

The FDA has granted avasopasem a priority review for severe oral mucositis in patients with head and neck cancer who are receiving radiotherapy.

5.

onclive.com

onclive.com/view/avasopasem-reduces-severe-oral-mucositis-in-patients-receiving-chemoradiotherapy-for-advanced-head-and-neck-cancer

Avasopasem Reduces Severe Oral Mucositis In Patients ...

A significant reduction in severe oral mucositis was observed with avasopasem manganese (GC4419) in patients receiving chemoradiotherapy for ...

6.

onclive.com

onclive.com/view/fda-issues-crl-to-nda-for-avasopasem-in-radiotherapy-induced-severe-oral-mucositis

FDA Issues CRL to NDA for Avasopasem in Radiotherapy ...

Regarding safety, no significant toxicities specific to avasopasem were observed, and there was no increase in the known toxicities of IMRT plus ...

7.

synapse.patsnap.com

synapse.patsnap.com/drug/c7e92c855ad142a2b4e46849c05938c5

Avasopasem manganese - Drug Targets, Indications, Patents

Phase 1IIT. Phase 1 Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor ...