What side effects are associated with this type of intervention?

Common treatments for HER2-positive breast cancer, such as trastuzumab, pertuzumab, and trastuzumab emtansine, are associated with several side effects. Trastuzumab can cause cardiac dysfunction, including heart failure, and infusion-related reactions like fever and chills. Pertuzumab may lead to diarrhea, fatigue, and neutropenia. Trastuzumab emtansine often results in fatigue, nausea, thrombocytopenia, and elevated liver enzymes. These therapies can also cause more general side effects such as fatigue, nausea, and diarrhea.

What prior FDA approvals exist?

The FDA has approved several drugs targeting the HER2 protein for the treatment of HER2-positive breast cancer. Key drugs include trastuzumab, which has shown significant benefits in progression-free survival, and trastuzumab emtansine, used in later-line settings. Neratinib, in combination with capecitabine, is approved for patients who have received two or more prior anti-HER2 regimens. Lapatinib, also combined with capecitabine, is another option for patients progressing on trastuzumab. These treatments have been pivotal in managing HER2-positive breast cancer, offering various options depending on the patient's treatment history and disease progression.

What other types of research exist?

Promising novel alternatives to ORM-5029 for HER2-positive breast cancer patients include: 1) BAY 80-6946, a PI3K alpha/delta inhibitor, which may improve outcomes when added to HER2-targeted therapies in refractory cases. 2) ZHER2:342, a small HER2-binding affibody molecule, which could serve as an alternative or complement to trastuzumab. 3) Trastuzumab Deruxtecan, an antibody-drug conjugate, which has shown efficacy in previously treated HER2-positive breast cancer. These options should be discussed with a healthcare provider to determine the best course of action.

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Monoclonal Antibodies

ORM-5029 for HER2-Positive Breast Cancer

Phase 1

Recruiting

Research Sponsored by Orum Therapeutics USA, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 30 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Specific side effects of ORM-5029 are not listed but may include typical reactions related to cancer drugs such as nausea, fatigue, risk of infection, allergic reactions including those similar to pertuzumab if previously experienced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Define the Duration of Response (DOR) of ORM-5029 based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Dose Expansion Only]

Define the Objective Response Rate (ORR) of ORM-5029 based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Dose Expansion Only]

Determination of Maximum Tolerated Dose (MTD) and Expansion Dose Level (EDL) [Dose Escalation Only]

+1 more

Secondary study objectives

Assess Progression-free survival (PFS) of ORM-5029 based on RECIST 1.1

Define Clinical Benefit Rate (CBR) of ORM-5029 based on RECIST 1.1

Define Duration of Response (DOR) of ORM-5029 based on RECIST 1.1 [Dose Escalation Only]

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 Dose ExpansionExperimental Treatment1 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 EscalationExperimental Treatment1 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.

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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

HER2-directed therapies, such as trastuzumab, pertuzumab, and trastuzumab emtansine, work by targeting the HER2 protein on the surface of cancer cells. Trastuzumab binds to the HER2 receptor, inhibiting cell proliferation and signaling the immune system to destroy the cancer cells. Pertuzumab prevents HER2 from pairing with other HER receptors, further blocking cell growth signals. Trastuzumab emtansine combines trastuzumab with a chemotherapy agent, delivering targeted cytotoxic effects to HER2-positive cells. These treatments are vital for managing HER2-positive breast cancer, as they specifically target the mechanisms driving tumor growth, leading to improved survival and quality of life for patients.

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