HER2-positive Breast CancerPhase 1NCT05511844
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
A Phase 1 study testing ORM-5029 in people with HER2-positive Breast Cancer and HER-2 Protein Overexpression, run by Orum Therapeutics USA, Inc. at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer, HER-2 Protein Overexpression, HER-2 Gene Amplification
- What is being tested?
- ORM-5029
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 11 sitesUnited States
- Study dates
- 3 Oct 2022to 2 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have histologically confirmed advanced breast cancer that is HER2+ by In Situ Hybridization (ISH) and/or at least 1+ staining by Immunohistochemistry (IHC), determined at the institution.
- Participant is not a candidate for or would be unlikely to tolerate or derive significant clinical benefit from, appropriate standard-of-care therapy, or the participant declines standard-of-care therapy, or the participant did not tolerate standard-of-care therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Evaluable disease (for participants in the Part 1 Dose Escalation) or measurable disease as per RECIST v1.1 (for participants in the Part 2 Dose Expansion).
- Acceptable organ function at Screening.
- Acceptable hematologic function at Screening.
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- Adequate coagulation parameters at Screening.
- Female participants of childbearing potential must:
- 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.
- Male participants with female partners of childbearing potential must:
- 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.
- Resolution of all toxicities of prior therapy or surgical procedures to baseline or Grade 1 (except for neuropathy, which must have resolved to Grade ≤2, hypothyroidism requiring medication, and alopecia).
- Adequate cardiac left ventricular function, as defined by a left ventricular ejection fraction (LVEF) ≥ institutional standard of normal.
- Life expectancy of ≥12 weeks according to the Investigator's judgment.
Who cannot join
- Systemic antineoplastic agent or radiation therapy given within 14 days prior to the first dose of ORM-5029.
- Known sensitivity to any of the ingredients of ORM-5029, including previously reported infusion reactions to pertuzumab leading to pertuzumab treatment discontinuation.
- History of other malignancy within the last 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.
- Symptomatic central nervous system (CNS) metastases or presence of leptomeningeal disease. Participant with previously treated brain metastases may participate.
- Pregnant or breastfeeding.
- Major surgery (excluding placement of vascular access) within 4 weeks prior to first dose of ORM-5029.
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- Uncontrolled hypertension (systolic BP ≥160 mmHg; diastolic BP ≥100 mmHg) despite adequate treatment prior to the first dose of ORM-5029.
- Cardiac diseases currently or within the last 6 months as defined by New York Heart Association ≥Class 2.
- Mean resting QT interval corrected for heart rate (QTc) interval using the Fridericia formula (QTcF) >450 msec for males and >470 msec for females.
- Concurrent treatment with medications that are well-known to prolong the QT interval (see CredibleMeds website: https://www.crediblemeds.org/) unless a participant is QT stable on QT prolonging medication for at least 4 weeks.
- Severe dyspnea at rest, due to complications of advanced malignancy.
- Past medical history or complications of interstitial lung disease. Note: Participants with history of radiation induced interstitial lung disease may be enrolled if the participant's symptoms have recovered
- Active, uncontrolled bacterial, fungal, or viral infection, including known hepatitis B virus (HBV), known hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness.
- 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:
- CD4+ (cluster of differentiation 4) T-cell counts ≥350 cells/μL
- No prior history of AIDS-defining opportunistic infections
- Received established anti-retroviral therapy for at least four weeks and have an HIV viral load <400 copies/mL prior to enrolment.
- 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.
- Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of participants with Gilbert's Syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per Investigator assessment).
- Moderate or severe hepatic impairment (i.e., Child-Pugh class B or C).
- Any bleeding disorder (e.g., coagulopathy) or history of chronic bleeding and participants on therapeutic anticoagulant therapy during the treatment. Note: Participants on prophylactic anticoagulant therapy are considered eligible.
- Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Alabama Birmingham
Birmingham, Alabama, 35233
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
NEXT Oncology - Virginia Cancer Specialists
Fairfax, Virginia, 22031
MD Anderson Cancer Center
Houston, Texas, 77030
University of California - Los Angeles
Los Angeles, California, 90095
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, 32703
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medicine-New York
New York, New York, 10065
NEXT Oncology
San Antonio, Texas, 78229
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Washington University
St Louis, Missouri, 63110
About this study
Official title: Phase I Multicenter, Open-Label, First-in-Human Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
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.
- Conditions
- HER2-positive Breast Cancer, HER-2 Protein Overexpression, HER-2 Gene Amplification, HER2 Gene Mutation
- Being tested
- ORM-5029
- Keywords
- HER2 Expressing, HER2 Positive, HER2 Associated, Antibody Drug Conjugate, Protein-Degradation, GSPT1, Celmod, Imid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORM-5029Drug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Escalation | Experimental | 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. Receives: Drug: ORM-5029 |
| Part 2 Dose Expansion | Experimental | 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). Receives: Drug: ORM-5029 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Maximum Tolerated Dose (MTD) and Expansion Dose Level (EDL) [Dose Escalation Only]
Identify the Dose-limiting Toxicities (DLTs) for each dose level tested and determine the MTD and EDL for ORM-5029
Measured: DLT assessment period: At the end of Cycle 1 (each cycle is 21 or 28 days); Approximately 18 months for MTD and EDL
Incidence of Adverse Events (AEs)
Evaluate the safety and tolerability of ORM-5029 by identifying the treatment-emergent adverse events (TEAEs)
Measured: Every cycle (each cycle is 21 or 28 days) until study discontinuation; Approximately 30 months
Define the Objective Response Rate (ORR) of ORM-5029 based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Dose Expansion Only]
ORR is defined as the percentage of subjects with Partial Response (PR) or Complete Response (CR)
Measured: Approximately 30 months
Define the Duration of Response (DOR) of ORM-5029 based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Dose Expansion Only]
DOR is defined as the length of time from the date of the first documented response (PR or CR) until the date of first documented progression or date of death from any cause, whichever came first
Measured: Approximately 30 months
Secondary outcomes (10)
Assess pharmacokinetic (PK) parameters including area under the concentration versus time curve from time 0 hours to the last quantifiable concentration (AUC0-last) and from time 0 hours to infinity (AUC0-inf)
Measured: Serial PK collections at on Days 1, 2, 4, 8 and 15 of Cycle 1 and Day 1 of Cycle 3 (Pre-dose and at multiple timepoints [up to 6 hours]; each cycle is 21 or 28 days)
Assess maximum plasma and serum drug concentration (Cmax)
Measured: Serial PK collections at on Days 1, 2, 4, 8 and 15 of Cycle 1 and Day 1 of Cycle 3 (Pre-dose and at multiple timepoints [up to 6 hours]; each cycle is 21 or 28 days)
Define time to Cmax (Tmax)
Measured: Serial PK collections at on Days 1, 2, 4, 8 and 15 of Cycle 1 and Day 1 of Cycle 3 (Pre-dose and at multiple timepoints [up to 6 hours]; each cycle is 21 or 28 days)
Access pharmacokinetic (PK) parameters including terminal rate consent and terminal elimination half-life (t1/2)
Measured: Serial PK collections at Baseline, Days 2, 4, 8 and 15 of Cycle 1 and Day 1 of Cycle 3 (Pre-dose and at multiple timepoints [up to 6 hours]; each cycle is 21 or 28 days)
Define Clinical Benefit Rate (CBR) of ORM-5029 based on RECIST 1.1
CBR is defined as CR + PR + stable disease (SD) up to 4 months
Measured: Approximately 30 months
Define Time to Response (TTR) of ORM-5029 based on RECIST 1.1
TTR is defined as the length of time from baseline until the date of first documented response (PR or CR)
Measured: Approximately 30 months
Define Duration of Response (DOR) of ORM-5029 based on RECIST 1.1 [Dose Escalation Only]
DOR is defined as the length of time from the date of the first documented response (PR or CR) until the date of first documented progression or date of death from any cause, whichever came first
Measured: Approximately 30 months
Assess Progression-free survival (PFS) of ORM-5029 based on RECIST 1.1
PFS is defined as the length of time from baseline until the date of first documented progression or date of death from any cause, whichever came first
Measured: Approximately 30 months
Assess overall survival (OS)
Measured: Following study discontinuation until withdrawal for any reason or death; Approximately 30 months
Incidence of anti-drug antibody (ADA) against ORM-5029
Measured: Sample collection at Baseline, Day 1 of every Cycle until study discontinuation (each cycle is 21 or 28 days); Approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start3 Oct 2022
- Primary completion2 Jun 2025
- Study completion2 Jun 2025
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orum Therapeutics USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511844
- Sponsor's protocol ID
- ORM-5029-01-001
- Status last verified
- Jul 2025
- First submitted
- 17 Aug 2022
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Multicenter, Open-Label, First-in-Human Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05511844
- Acronym / sponsor ID
- ORM-5029-01-001
- Conditions
- HER2-positive Breast Cancer, HER-2 Protein Overexpression, HER-2 Gene Amplification, HER2 Gene Mutation
- Keywords
- HER2 Expressing, HER2 Positive, HER2 Associated, Antibody Drug Conjugate, Protein-Degradation, GSPT1, Celmod, Imid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Orum Therapeutics USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Escalation | Experimental | Drug: ORM-5029All 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. |
| Part 2 Dose Expansion | Experimental | Drug: ORM-5029All 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Have histologically confirmed advanced breast cancer that is HER2+ by In Situ Hybridization (ISH) and/or at least 1+ staining by Immunohistochemistry (IHC), determined at the institution.
- Participant is not a candidate for or would be unlikely to tolerate or derive significant clinical benefit from, appropriate standard-of-care therapy, or the participant declines standard-of-care therapy, or the participant did not tolerate standard-of-care therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Evaluable disease (for participants in the Part 1 Dose Escalation) or measurable disease as per RECIST v1.1 (for participants in the Part 2 Dose Expansion).
- Acceptable organ function at Screening.
Key exclusion criteria (23 listed)
- Systemic antineoplastic agent or radiation therapy given within 14 days prior to the first dose of ORM-5029.
- Known sensitivity to any of the ingredients of ORM-5029, including previously reported infusion reactions to pertuzumab leading to pertuzumab treatment discontinuation.
- History of other malignancy within the last 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.
- Symptomatic central nervous system (CNS) metastases or presence of leptomeningeal disease. Participant with previously treated brain metastases may participate.
- Pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORM-5029Intravenous infusion | Drug | Part 1 Dose Escalation, Part 2 Dose Expansion |
Primary outcome
Determination of Maximum Tolerated Dose (MTD) and Expansion Dose Level (EDL) [Dose Escalation Only]
Time frame: DLT assessment period: At the end of Cycle 1 (each cycle is 21 or 28 days); Approximately 18 months for MTD and EDL
Identify the Dose-limiting Toxicities (DLTs) for each dose level tested and determine the MTD and EDL for ORM-5029
Incidence of Adverse Events (AEs)
Time frame: Every cycle (each cycle is 21 or 28 days) until study discontinuation; Approximately 30 months
Evaluate the safety and tolerability of ORM-5029 by identifying the treatment-emergent adverse events (TEAEs)
Define the Objective Response Rate (ORR) of ORM-5029 based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Dose Expansion Only]
Time frame: Approximately 30 months
ORR is defined as the percentage of subjects with Partial Response (PR) or Complete Response (CR)
Define the Duration of Response (DOR) of ORM-5029 based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Dose Expansion Only]
Time frame: Approximately 30 months
DOR is defined as the length of time from the date of the first documented response (PR or CR) until the date of first documented progression or date of death from any cause, whichever came first
10 secondary outcomes
Assess pharmacokinetic (PK) parameters including area under the concentration versus time curve from time 0 hours to the last quantifiable concentration (AUC0-last) and from time 0 hours to infinity (AUC0-inf)
Time frame: Serial PK collections at on Days 1, 2, 4, 8 and 15 of Cycle 1 and Day 1 of Cycle 3 (Pre-dose and at multiple timepoints [up to 6 hours]; each cycle is 21 or 28 days)
Assess maximum plasma and serum drug concentration (Cmax)
Time frame: Serial PK collections at on Days 1, 2, 4, 8 and 15 of Cycle 1 and Day 1 of Cycle 3 (Pre-dose and at multiple timepoints [up to 6 hours]; each cycle is 21 or 28 days)
Define time to Cmax (Tmax)
Time frame: Serial PK collections at on Days 1, 2, 4, 8 and 15 of Cycle 1 and Day 1 of Cycle 3 (Pre-dose and at multiple timepoints [up to 6 hours]; each cycle is 21 or 28 days)
Access pharmacokinetic (PK) parameters including terminal rate consent and terminal elimination half-life (t1/2)
Time frame: Serial PK collections at Baseline, Days 2, 4, 8 and 15 of Cycle 1 and Day 1 of Cycle 3 (Pre-dose and at multiple timepoints [up to 6 hours]; each cycle is 21 or 28 days)
Define Clinical Benefit Rate (CBR) of ORM-5029 based on RECIST 1.1
Time frame: Approximately 30 months
Define Time to Response (TTR) of ORM-5029 based on RECIST 1.1
Time frame: Approximately 30 months
Define Duration of Response (DOR) of ORM-5029 based on RECIST 1.1 [Dose Escalation Only]
Time frame: Approximately 30 months
Assess Progression-free survival (PFS) of ORM-5029 based on RECIST 1.1
Time frame: Approximately 30 months
Assess overall survival (OS)
Time frame: Following study discontinuation until withdrawal for any reason or death; Approximately 30 months
Incidence of anti-drug antibody (ADA) against ORM-5029
Time frame: Sample collection at Baseline, Day 1 of every Cycle until study discontinuation (each cycle is 21 or 28 days); Approximately 30 months
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ORM-5029 in people with HER2-positive Breast Cancer and HER-2 Protein Overexpression, run by Orum Therapeutics USA, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Maximum Tolerated Dose (MTD) and Expansion Dose Level (EDL) [Dose Escalation Only] (time frame: DLT assessment period: At the end of Cycle 1 (each cycle is 21 or 28 days); Approximately 18 months for MTD and EDL). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.