ORM-5029 for HER2-Positive Breast Cancer

Recruiting at 10 trial locations

Overseen By Orum Therapeutics USA, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Orum Therapeutics USA, Inc.

Must not be taking: QT prolonging medications

Disqualifiers: CNS metastases, Uncontrolled hypertension, Cardiac diseases, others

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

Compensation: Varies

Number of Visits: Unknown

87 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new drug called ORM-5029 in patients with advanced cancers that have the HER2 protein. The drug aims to find and attack these specific cancer cells. ORM-5029 is being tested for its ability to target HER2-positive cancer cells, a strategy previously explored with other drugs.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have taken any systemic cancer treatments or radiation therapy within 14 days before starting the trial, and you should not be on medications that prolong the QT interval unless stable for at least 4 weeks.

What makes the drug ORM-5029 unique for HER2-positive breast cancer?

The drug ORM-5029 is unique because it represents a new approach in targeting HER2-positive breast cancer, potentially offering an alternative for patients whose disease progresses despite existing anti-HER2 therapies like trastuzumab. While specific details about ORM-5029 are not provided, it may involve novel mechanisms or combinations that address unmet needs in advanced HER2-positive breast cancer. ^{1 2 3 4 5}

What data supports the effectiveness of the drug ORM-5029 for HER2-Positive Breast Cancer?

Research shows that targeting HER2 in breast cancer with specific therapies has significantly improved survival and disease control. Similar treatments, like trastuzumab and pertuzumab, have shown benefits in HER2-positive breast cancer, suggesting that ORM-5029 may also be effective. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with advanced breast cancer that tests positive for HER2. Participants should have tried standard treatments without success, or be unable to tolerate them. They must have a life expectancy of at least 12 weeks, good heart function, and stable organ and blood functions. Women of childbearing age need a negative pregnancy test and agree to use contraception; men also need to agree to contraception use.

Inclusion Criteria

Adequate coagulation parameters at Screening

My blood test results are within normal ranges.

My side effects from previous treatments have mostly gone away or are mild.

Exclusion Criteria

I have brain metastases but have received treatment for them.

Pregnant or breastfeeding

I haven't had cancer in the last 2 years, except for certain non-aggressive types.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive ORM-5029 in escalating dose cohorts to determine the Maximum Tolerated Dose (MTD) and Expansion Dose Level (EDL)

Approximately 18 months

Dose Expansion

Participants receive ORM-5029 at dose levels with pharmacodynamic activity or efficacy signals

Approximately 30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ORM-5029

Trial Overview ORM-5029 is being tested in this Phase 1 trial on people with HER2-positive advanced solid tumors. The study has two parts: first, finding the right dose (Dose Escalation), then seeing how well it works at that dose (Dose Expansion).

How Is the Trial Designed?

Group I: Part 2 Dose Expansion Experimental Treatment 1 Intervention

All participants receive ORM-5029 at dose levels with pharmacodynamic activity or efficacy signals (Expansion Cohort A) or at the Expansion Dose Level (EDL) (Expansion Cohorts B and C).

Group II: Part 1 Dose Escalation Experimental Treatment 1 Intervention

All participants receive ORM-5029 in escalating dose cohorts in Part 1 Dose Escalation and at the Expansion Dose Level (EDL) in Part 2 Dose Expansion.

Who Is Running the Clinical Trial?

Orum Therapeutics USA, Inc.

Lead Sponsor

Trials

1

Recruited

90+

Published Research Related to This Trial

In a study of 208 patients with advanced HER2-positive breast cancer receiving first-line anti-HER2 therapy for at least 1 year, the median overall survival was found to be 81 months, indicating long-term efficacy of the treatment.

The overall response rate to the therapy was 87.5%, with a median progression-free survival of 39.5 months, although 4.8% of patients experienced cardiotoxicity, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome with targeted therapy in advanced/metastatic HER2-positive breast cancer: The Royal Marsden experience. Battisti, NML., Tong, D., Ring, A., et al.[2020]

HER2-targeted therapies, including trastuzumab and newer agents like lapatinib and pertuzumab, have significantly improved survival rates for patients with HER2-positive breast cancer, transforming it from a poor prognosis to a more manageable condition.

Current research is exploring the effectiveness of HER2-targeted treatments without chemotherapy and assessing the benefits of these therapies earlier in the treatment process, indicating a shift towards more personalized and effective management strategies for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of HER2-positive breast cancer. Figueroa-Magalhães, MC., Jelovac, D., Connolly, R., et al.[2022]

Targeted anti-HER2 therapies have significantly improved disease control and survival rates in patients with metastatic HER2-positive breast cancer, which affects about 20% of breast cancer cases.

This review highlights the importance of these therapies as the standard of care for first-line treatment and discusses ongoing advancements aimed at addressing remaining challenges in treating this aggressive cancer type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting HER2 in Advanced Breast Cancer. Zhu, X., Joy, AA.[2018]

Trastuzumab (Herceptin) has been shown to significantly improve outcomes in HER-2-positive breast cancer, reducing the risk of recurrence by about 50% and the risk of death by nearly 30%, based on evidence from five large phase III adjuvant trials.

Herceptin is now approved for use in combination with chemotherapy for the adjuvant treatment of HER-2-positive breast cancer, marking a significant advancement in the management of this previously challenging condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Trastuzumab (Herceptin) in the adjuvant treatment of HER-2-positive early breast cancer]. Láng, I., Hitre, E.[2015]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Trastuzumab, Pertuzumab, and Docetaxel as the First Line for HER-2-Positive Metastatic Breast Cancer among Arabs. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term outcome with targeted therapy in advanced/metastatic HER2-positive breast cancer: The Royal Marsden experience. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of HER2-positive breast cancer. [2022]

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

Targeting HER2 in Advanced Breast Cancer. [2018]

5. India pubmed.ncbi.nlm.nih.gov

Human epidermal growth factor receptor 2 inhibits activating transcription factor 7 to promote breast cancer cell migration by activating histone lysine demethylase 1. [2022]

6. Hungary pubmed.ncbi.nlm.nih.gov

[Trastuzumab (Herceptin) in the adjuvant treatment of HER-2-positive early breast cancer]. [2015]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Targeted therapy in her2-positive metastatic breast cancer: a review of the literature. [2018]

8. Poland pubmed.ncbi.nlm.nih.gov

Current therapeutic strategies of anti-HER2 treatment in advanced breast cancer patients. [2020]