Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors (NCT05511844) | Clinical Trial Compass
TerminatedPhase 1
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
Stopped: Sponsor Decision
United States25 participantsStarted 2022-10-03
Plain-language summary
This is a Phase 1 first-in-human study of ORM-5029 in participants with HER2-expressing advanced solid tumors. The study consists of two parts: a Part 1 Dose Escalation and Part 2 Dose Expansion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Have a negative pregnancy test (serum) at Screening.
. Agree to use at least one highly effective form of contraception during study treatment and after the last dose of ORM-5029.
. Agree to use at least one highly effective form of contraception during study treatment and after the last dose of ORM-5029.
. Refrain from donating sperm during their participation in the study and after the last dose of ORM-5029.
Exclusion criteria
. HIV Seropositive participants who are healthy and at low risk for AIDS-related outcomes can be considered eligible. HIV positive participants must be evaluated and discussed with the Medical Monitor, and should have:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determination of Maximum Tolerated Dose (MTD) and Expansion Dose Level (EDL) [Dose Escalation Only]
Timeframe: DLT assessment period: At the end of Cycle 1 (each cycle is 21 or 28 days); Approximately 18 months for MTD and EDL
2
Incidence of Adverse Events (AEs)
Timeframe: Every cycle (each cycle is 21 or 28 days) until study discontinuation; Approximately 30 months
3
Define the Objective Response Rate (ORR) of ORM-5029 based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Dose Expansion Only]
Timeframe: Approximately 30 months
4
Define the Duration of Response (DOR) of ORM-5029 based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Dose Expansion Only]
. Participants who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks prior to the first dose of ORM-5029 and have undetectable HBV viral load prior to enrolment. Note: Participants must remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.
. Participants with a history of HCV infection are eligible if they have received curative treatment and HCV viral load is undetectable prior to enrolment. Participants who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible. Note: Participants must have completed curative antiviral therapy at least 4 weeks prior to enrolment.