What is the mechanism of action of this treatment?

Kinase inhibitors, such as those being studied in the trial OTS167, target specific enzymes involved in cell signaling pathways that regulate cancer cell growth and proliferation. By inhibiting these enzymes, these treatments can effectively stop the growth of cancer cells. This targeted approach is crucial for breast cancer patients as it can lead to more effective treatments with potentially fewer side effects compared to traditional chemotherapy. Tailoring treatments based on the molecular characteristics of the cancer can improve outcomes and provide a more personalized therapy.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly kinase inhibitors like OTS167, often have side effects such as fatigue, nausea, and increased liver function tests. Other targeted therapies, such as aromatase inhibitors and tamoxifen, can cause bone density loss, fractures, cardiovascular risks, and menopausal symptoms. Chemotherapy agents like paclitaxel and carboplatin may lead to neurotoxicity, granulocytopenia, and anemia. Overall, while these treatments can be effective, they come with a range of manageable but significant side effects.

What prior FDA approvals exist?

Several kinase inhibitors have been approved by the FDA for the treatment of breast cancer. Notably, HER2 inhibitors such as trastuzumab (Herceptin) and pertuzumab (Perjeta) target the HER2 receptor, which is overexpressed in some breast cancers. CDK4/6 inhibitors like palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio) inhibit cyclin-dependent kinases 4 and 6, which are crucial for cell cycle progression. These treatments, similar to the investigational agent OTS167, aim to inhibit key pathways involved in cancer cell proliferation.

What other types of research exist?

Promising alternatives to OTS167 for breast cancer treatment include: 1) Alpelisib, a PI3K inhibitor approved for HR-positive, HER2-negative advanced breast cancer with PIK3CA mutations. 2) Tucatinib, a HER2-targeted tyrosine kinase inhibitor for HER2-positive breast cancer. 3) Sacituzumab govitecan, an antibody-drug conjugate for triple-negative breast cancer. 4) Pembrolizumab, an immune checkpoint inhibitor for PD-L1 positive triple-negative breast cancer. These therapies have shown efficacy in clinical trials and are relevant for various subtypes of advanced breast cancer.

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Protein Kinase Inhibitor

MELK Inhibitor OTS167PO for Breast Cancer

Phase 1

Recruiting

Research Sponsored by OncoTherapy Science, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor

Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Must not have

Patients with primary brain tumors

Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) not using adequate birth control

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of OTS167PO aren't listed here, common ones in trials like this may include nausea, fatigue, allergic reactions, blood count changes leading to increased infection risk or bleeding problems. The severity will help determine the maximum tolerated dose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer cannot be removed through surgery due to health reasons or because the tumor can't be surgically removed.

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I am fully active or can carry out light work.

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My breast cancer is confirmed and has spread or is advanced.

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My cancer is low in estrogen and progesterone receptors, and not HER2 positive.

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My cancer came back or didn't respond to 1st or 2nd treatments, including specific drugs for TNBC.

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My cancer has returned or didn’t respond to treatment, and there’s no standard treatment available.

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My cancer can be measured and biopsied easily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a brain tumor that originated in my brain.

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I am not pregnant, breastfeeding, and if I can have children, I use effective birth control.

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My blood tests show liver or kidney function outside the normal range.

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I do not have a serious infection or fever over 38ºC in the last week.

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I need surgery for my cancer, whether it's where it started or where it has spread.

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I haven't taken any hormonal therapy not for breast cancer within the last week.

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I have a serious heart condition.

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I have a blood cancer such as leukemia, lymphoma, or multiple myeloma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: OTS167POExperimental Treatment1 Intervention

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Kinase inhibitors, such as those being studied in the trial OTS167, target specific enzymes involved in cell signaling pathways that regulate cancer cell growth and proliferation. By inhibiting these enzymes, these treatments can effectively stop the growth of cancer cells. This targeted approach is crucial for breast cancer patients as it can lead to more effective treatments with potentially fewer side effects compared to traditional chemotherapy. Tailoring treatments based on the molecular characteristics of the cancer can improve outcomes and provide a more personalized therapy.

Do our current clinical trial designs help to guide clinical practice?Promising novel therapies for the treatment of endometrial cancer.Indications and limitations of third-generation aromatase inhibitors.