MELK Inhibitor OTS167PO for Breast Cancer

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: OncoTherapy Science, Inc.

Must not be taking: Anti-neoplastic, Monoclonal antibodies, Herbal, others

Disqualifiers: Pregnancy, CNS metastases, Hematologic malignancy, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a pill called OTS167 to find out the highest dose that patients with advanced breast cancer can safely take.

Will I have to stop taking my current medications?

The trial requires that you stop taking any anti-cancer medications or monoclonal antibody therapies for your primary cancer at least 2 weeks before starting the study drug. Additionally, you must stop using herbal supplements and certain hormonal therapies not related to breast cancer treatment at least 1 week before starting the study.

What data supports the effectiveness of the drug OTS167PO for breast cancer?

Research shows that a similar drug, OTSSP167, which targets the same protein (MELK), has been effective in reducing tumor growth in various cancers, including breast cancer, in animal studies. This suggests that OTS167PO might also be effective in treating breast cancer by targeting the same pathway. ^{1 2 3 4 5}

Is the MELK inhibitor OTS167PO safe for humans?

The research does not provide specific safety data for humans, but it mentions that OTS167, a similar MELK inhibitor, has been used in preclinical models to suppress tumor growth. However, there are concerns about its selectivity and potential off-target effects, which means it might affect other parts of the body unintentionally. ^{1 2 4 5 6}

What makes the drug OTS167PO unique for treating breast cancer?

OTS167PO is unique because it targets the MELK (maternal embryonic leucine zipper kinase) pathway, which is often upregulated in breast cancer and other cancers, helping to suppress tumor growth by affecting cancer cell survival and stem-cell characteristics. Additionally, it can be administered orally, which is different from many cancer treatments that require intravenous administration. ^{1 3 4 6 7}

Eligibility Criteria

This trial is for women over 18 with advanced or metastatic breast cancer that's unresponsive to standard treatments. They must have a life expectancy of at least 3 months, agree to use contraception, and be able to consent. Excluded are pregnant/lactating women, those with serious infections or other health issues that could affect safety, and anyone who has had certain treatments recently.

Inclusion Criteria

My side effects from previous cancer treatments are mild, except for possible stable nerve pain.

Patients must have a way to measure their disease using specific guidelines for triple-negative breast cancer.

Patients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol

Exclusion Criteria

I have a brain tumor that originated in my brain.

Your blood tests show low levels of white blood cells, platelets, or hemoglobin.

I am able to follow the study's requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive OTS167PO to determine the maximum tolerated dose

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• OTS167PO

Trial Overview The study tests the maximum tolerated dose of OTS167PO, an oral capsule treatment for patients with relapsed/refractory breast cancer. It aims to find the highest dose patients can take without severe side effects by gradually increasing amounts under close supervision.

Participant Groups

Group I: OTS167PO Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

OncoTherapy Science, Inc.

Lead Sponsor

Trials

7

Recruited

220+

References

1. China pubmed.ncbi.nlm.nih.gov

[Effect of MELK Inhibitor OTSSP167 on Diffuse Large B-Cell Lymphoma]. [2023]

2. England pubmed.ncbi.nlm.nih.gov

MELK is not necessary for the proliferation of basal-like breast cancer cells. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Development of an orally-administrative MELK-targeting inhibitor that suppresses the growth of various types of human cancer. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Preclinical evaluation of biomarkers associated with antitumor activity of MELK inhibitor. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

MELK expression in ovarian cancer correlates with poor outcome and its inhibition by OTSSP167 abrogates proliferation and viability of ovarian cancer cells. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

[18F]F-ET-OTSSP167 Targets Maternal Embryo Leucine Zipper Kinase for PET Imaging of Triple-Negative Breast Cancer. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

OTSSP167 Abrogates Mitotic Checkpoint through Inhibiting Multiple Mitotic Kinases. [2021]