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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
Study Summary
This trial is testing a new cancer drug in people with HER2-expressing tumors. The study has two parts: first they will test different doses of the drug to see what is safe, then they will expand the study to test how well the drug works.
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.Check my eligibility
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).See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Access pharmacokinetic (PK) parameters including terminal rate consent and terminal elimination half-life (t1/2)
Assess Progression-free survival (PFS) of ORM-5029 based on RECIST 1.1
Assess maximum plasma and serum drug concentration (Cmax)
+7 moreTrial 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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Who is running the clinical trial?
Orum Therapeutics USA, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases but have received treatment for them.My blood test results are within normal ranges.I haven't had cancer in the last 2 years, except for certain non-aggressive types.My blood pressure is high (≥160/100 mmHg) despite treatment.I have had interstitial lung disease but have recovered from it.My side effects from previous treatments have mostly gone away or are mild.My organs are functioning well.My cancer can be measured or evaluated for treatment response.I can take care of myself but might not be able to do heavy physical work.My heart pumps blood well, meeting the normal standards.I've been stable on medication that affects heart rhythm for over 4 weeks.My advanced breast cancer is confirmed HER2 positive by specific tests.I haven't had cancer treatment or radiation in the last 14 days.I have a bleeding disorder or am on blood thinners.My liver function is moderately or severely impaired.I do not have any life-threatening illnesses or uncontrolled infections.I have not had serious heart problems in the last 6 months.I am allergic to ORM-5029 or its components, including having had a bad reaction to pertuzumab.I do not have uncontrolled kidney, pancreas, or liver issues, except for allowed conditions.I have not had major surgery in the last 4 weeks.I experience severe shortness of breath at rest due to my advanced cancer.I agree to use effective birth control and not donate sperm while on and after ORM-5029 treatment.I am not pregnant and agree to use effective birth control during and after the study.I do not have any active, uncontrolled infections or known HIV, HBV, or HCV.I cannot or choose not to undergo standard cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Dose Escalation
- Group 2: Part 2 Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has ORM-5029 been sanctioned by the FDA?
"As this is a Phase 1 clinical trial, there is minimal evidence to support the safety and efficacy of ORM-5029. We rate it at a score of 1 in terms of overall risk."
Answered by AI
How many participants is the research team recruiting for this experiment?
"Affirmative. Information hosted on clinicaltrials.gov demonstrate that this trial is actively enrolling subjects, having been first made available to the public on October 3rd 2022 and last updated November 1st of the same year. The study requires 87 individuals from 2 different medical facilities."
Answered by AI
Is recruitment of participants for this research still ongoing?
"The information on clinicaltrials.gov affirms that this research is actively looking for volunteers. Originally posted on October 3rd 2022, the trial was most recently updated a month later in November 1st"
Answered by AI
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