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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new oral treatment called OTS167PO, a MELK inhibitor, for women with advanced breast cancer that has returned or isn't responding to existing treatments. The goal is to determine the highest dose patients can safely tolerate. Eligible participants have breast cancer that cannot be managed with surgery and have already tried standard therapies without success. The trial specifically includes those with triple-negative breast cancer, a subtype lacking certain hormone receptors, who have measurable disease. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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.

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

Research shows that OTS167PO, the drug being tested, remains in the early stages of clinical trials. This phase focuses on safety, with limited information on patient tolerance. As the trial begins, the primary aim is to determine the highest dose patients can take without serious side effects.

Earlier studies demonstrated that OTS167PO could slow the growth of various cancer cells, including breast cancer cells. However, detailed safety results in humans are not yet available. Treatments in this phase are typically tested for safety and potential side effects.

Prospective participants should understand that the trial's main goal is to find a safe dose, and side effects are still under investigation. Participants should be aware of potential risks as doctors learn more about the treatment's effects in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for breast cancer, like chemotherapy and hormone therapy, target rapidly dividing cells or specific hormone receptors. But OTS167PO works differently by inhibiting MELK, a protein that plays a role in cancer cell survival and proliferation. Researchers are excited about this because targeting MELK could potentially overcome resistance seen in other treatments and offer a new pathway to attack cancer cells, especially in aggressive or treatment-resistant forms of breast cancer. This novel approach could provide new hope for patients who have limited options with current therapies.

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

Research has shown that OTS167PO, a drug that blocks the protein MELK, may help treat cancer. Lab studies found that OTS167 was effective against certain breast cancer cells, specifically MDA-MB-231 and MCF7. This suggests the drug might be useful for treating aggressive breast cancer types. OTS167 has also been tested for other uses, such as fighting the flu, indicating it might have a wide range of effects. Although limited information exists from human studies, these early results support further research into using OTS167PO for breast cancer treatment. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: OTS167PO Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

OncoTherapy Science, Inc.

Lead Sponsor

Trials

7

Recruited

220+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02926690

NCT02926690 | Safety Study of MELK Inhibitor to Treat ... The purpose of this study is to determine the maximum tolerated dose (MTD) of OTS167 administered via oral capsule (PO) to patients with relapsed/refractory ...

2. veri.larvol.com veri.larvol.com/news/ots167/drug

News - OTS167 OTS167, a pharmacological inhibitor of MELK currently undergoing phase II clinical trials for treating cancer, potently inhibits influenza virus infections in ...

3. synapse.patsnap.com synapse.patsnap.com/drug/fd23abf6a42548a19e61f950dbca7645

OTS-167 - Drug Targets, Indications, Patents Experimental validation in MDA-MB-231 and MCF7 cells demonstrated the efficacy of five out of six tested molecules among those scored highest by the model. In ...

4. globenewswire.com globenewswire.com/news-release/2022/05/24/2449671/0/en/Metastatic-Breast-Cancer-Pipeline-Report-Emerging-Therapies-and-Treatment-Outlook-DelveInsight.html

Metastatic Breast Cancer Pipeline Report: Emerging Tenalisib was well tolerated and showed encouraging preliminary efficacy as a single agent in both primary and secondary resistant mBC; Data ...

5. theglobeandmail.com theglobeandmail.com/investing/markets/markets-news/GetNews/35368463/triple-negative-breast-cancer-market-insights-highlight-expanding-outlook-till-2034-delveinsight-evaluates-akeso-biopharma-prolynx-modernatx-oncotherapy-science-phoenix-molecular-designs/

Triple Negative Breast Cancer Market Insights Highlight ... The Triple Negative Breast Cancer market size was valued USD 4,676 million in 2025 and is anticipated to reach USD 7,083 million by 2034 with a ...

6. medchemexpress.com medchemexpress.com/OTSSP167.html?srsltid=AfmBOor7egmgFEg8ha8l2PatzrejHY3QVC4kP__lfuObxY_Yn2pUJbiE

OTSSP167 (OTS167) | MELK Inhibitor OTSSP167 inhibits the growth of A549 (lung), T47D (breast), DU4475 (breast), 22Rv1 (prostate) and HT1197 (bladder) cancer cells with IC50 values of 6.7, ...

7. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT02926690/

Clinical Trial: NCT02926690 - Breast Cancer The purpose of this study is to determine the maximum tolerated dose (MTD) of OTS167 administered via oral capsule (PO) to patients with relapsed/refractory ...