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HER2-positive Breast CancerPhase 1/2NCT07885683

MagSense® Human Epidermal Growth Factor Receptor 2 (HER2) Imaging Agent (MSH2IA)

A Phase 1/2 study testing The MagSense® HER2 Imaging Agent (MSH2IA) in people with HER2-positive Breast Cancer, run by Imagion Biosystems, Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This Phase 1b/2 study is designed as an open-label, multicenter, 3 group, interventional study in which Phase 1b will evaluate the pharmacokinetics (PK) of MSH2IA and Phase 2 will confirm lowest effective dose as well as evaluate image timing, and diagnostic performance of a selected dose of MSH2IA when administered… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
The MagSense® HER2 Imaging Agent (MSH2IA)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
30 Nov 2026to 23 Jul 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female participants ≥18 years of age and are willing to provide written informed consent.
  • In the opinion of the Investigator, willing and able to comply with required study procedures.
  • Histologically confirmed primary HER2+ breast cancer; participants with a second primary tumor in the contralateral breast are eligible, but only 1 side will be evaluated.
  • Primary tumor must be HER2+, defined according to ASCO/CAP 2018 guidelines as either IHC 3+ or IHC 2+ with confirmatory ISH-positive.
  • Phase 1b and Phase 2 (Imaging Schedule) participants must be node suspicious by SOC assessment.
  • No previous treatment of the primary tumor or ipsilateral axilla that includes surgery (other than biopsy), radiotherapy, or a biologic such as trastuzumab. In Phase 2 (Diagnostic Performance) only, participants who have received NCT are eligible if treatment has not included trastuzumab.
  • Female participants of nonchildbearing potential: defined as either surgically sterilized (eg, hysterectomy, bilateral salpingectomy, bilateral oophorectomy ≥6 weeks before screening) or postmenopausal (ie, no menses for 12 months without an alternative medical cause.
  • Female participants of childbearing potential are eligible to participate if not pregnant, not breastfeeding, and using birth control.

Who cannot join

  • Participants will be excluded from the study if ANY of the following criteria are applicable:
  • Contraindications to the use of the Magtrace™ and Sentimag® Magnetic Localization System (Magtrace 2018), including use before NCT when MRI will be the primary imaging method for evaluation of breast cancer
  • Previous or current diseases of Fe metabolism or history of adverse reactions to intravenous Fe products
  • Known hypersensitivity to trastuzumab, iron oxide, or polyethylene glycol compounds
  • Treatment by Herceptin® or biosimilar within prior six months
  • Planned or prior use of Magtrace™ and Sentimag as a diagnostic agent, as it might interfere with MagSense® evaluations
Show all 12Show fewer
  • Known clinical or radiological evidence of distant metastases (Stage IV disease)
  • Inflammatory breast cancer
  • Prior surgical axillary procedure, including SLNB or ALND, or previous radiation on the ipsilateral side of the breast cancer primary
  • Prior history of breast cancer in the ipsilateral breast
  • Metal devices or fragments other than post-breast biopsy clips in the ipsilateral axilla or in the ipsilateral chest
  • Any contraindications to MRI imaging

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mohammad Eghtedari, M.D., Ph.D. contact

626-739-8446

meghtedari@coh.org

About this study

Official title: A Phase 1b/2 Study Investigating MagSense® Human Epidermal Growth Factor Receptor 2 (HER2) Imaging Agent (MSH2IA) Using Magnetic Resonance Imaging in Participants With HER2+ Breast Cancer for the Assessment of Tumor Involvement in the Lymph Nodes (MSH2IA Phase 1b/2 Study)

This Phase 1b/2 study is designed as an open-label, multicenter, 3 group, interventional study in which Phase 1b will evaluate the pharmacokinetics (PK) of MSH2IA and Phase 2 will confirm lowest effective dose as well as evaluate image timing, and diagnostic performance of a selected dose of MSH2IA when administered by subareolar or peritumoral injection.

No hypothesis testing is planned. Comparative statistics will be used to generate hypotheses to be tested in subsequent studies.

Being tested
The MagSense® HER2 Imaging Agent (MSH2IA)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The MagSense® HER2 Imaging Agent (MSH2IA)Combination product

    Imaging Agent intended as an adjunct to MRI for the assessment of axillary nodal disease in participants diagnosed with HER2+ primary breast cancer.

Study groups in NCT07885683
Study groupRoleWhat they receive
Phase 1b - MSH2IA PharmacokineticsExperimentalParticipants enrolled in Phase 1b will receive MSH2IA to evaluate its pharmacokinetic (PK) profile.
Receives: Combination Product: The MagSense® HER2 Imaging Agent (MSH2IA)
Phase 2 - MSH2IA Dose and Diagnostic PerformanceExperimentalParticipants enrolled in Phase 2 will receive MSH2IA via subareolar or peritumoral injection to confirm the lowest effective dose, evaluate image timing, and assess the diagnostic performance of a selected dose of MSH2IA.
Receives: Combination Product: The MagSense® HER2 Imaging Agent (MSH2IA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1b: Level of Fe in blood

    PK MSH2IA Fe concentration > LLOQ in human whole blood

    Measured: 24 hours post injection

  2. Phase 2 (Imaging Schedule): Dose and Imaging schedule for MSH2IA

    MSH2IA dose to image suspicious versus normal nodes and Post dose MRI imaging timing

    Measured: 24 hours post injection

  3. Phase 2 (Diagnostic Performance): Diagnostic performance comparison between MSH2IA and SOC

    Patient level concordance of MSH2IA imaging to clinical pathology and Patient level concordance of MSH2IA to AxUS as measured by PPV, NPV, and Overall Predictive Concordance (PPV+NPV).

    Measured: 24 hours post injection

Secondary outcomes (1)

  1. Safety and Tolerability of MSH2IA Across All Phases

    All Phases: Assess safety and tolerability of MSH2IA Incidence and severity of AEs, serious adverse events and Injection site reactions (ISRs)

    Measured: From baseline through 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2026
  2. Study start30 Nov 2026 (estimated)
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion23 Jul 2029 (estimated)

Resources

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 1/2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Sequential
Model description
All participants are assigned to a single intervention group and receive MSH2IA for diagnostic imaging.
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07885683
Sponsor's protocol ID
IBI010105
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
21 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Voduc KD, Cheang MC, Tyldesley S, Gelmon K, Nielsen TO, Kennecke H. Breast cancer subtypes and the risk of local and regional relapse. J Clin Oncol. 2010 Apr 1;28(10):1684-91. doi: 10.1200/JCO.2009.24.9284. Epub 2010 Mar 1.

    PubMed 20194857

  • Veronesi U, Paganelli G, Viale G, Luini A, Zurrida S, Galimberti V, Intra M, Veronesi P, Robertson C, Maisonneuve P, Renne G, De Cicco C, De Lucia F, Gennari R. A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer. N Engl J Med. 2003 Aug 7;349(6):546-53. doi: 10.1056/NEJMoa012782.

    PubMed 12904519

  • Slamon DJ, Godolphin W, Jones LA, Holt JA, Wong SG, Keith DE, Levin WJ, Stuart SG, Udove J, Ullrich A, et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science. 1989 May 12;244(4905):707-12. doi: 10.1126/science.2470152.

    PubMed 2470152

  • Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987 Jan 9;235(4785):177-82. doi: 10.1126/science.3798106.

    PubMed 3798106

  • Shen J, Gilcrease MZ, Babiera GV, Ross MI, Meric-Bernstam F, Feig BW, Kuerer HM, Francis A, Ames FC, Hunt KK. Feasibility and accuracy of sentinel lymph node biopsy after preoperative chemotherapy in breast cancer patients with documented axillary metastases. Cancer. 2007 Apr 1;109(7):1255-63. doi: 10.1002/cncr.22540.

    PubMed 17330229

  • Sharifi N, Ahmad S. Breast cancer-related lymphedema: A critical review on recent progress. Surg Oncol. 2024 Oct;56:102124. doi: 10.1016/j.suronc.2024.102124. Epub 2024 Aug 23.

    PubMed 39208532

  • Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lonning PE, Borresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52. doi: 10.1038/35021093.

    PubMed 10963602

  • Kennecke H, Yerushalmi R, Woods R, Cheang MC, Voduc D, Speers CH, Nielsen TO, Gelmon K. Metastatic behavior of breast cancer subtypes. J Clin Oncol. 2010 Jul 10;28(20):3271-7. doi: 10.1200/JCO.2009.25.9820. Epub 2010 May 24.

    PubMed 20498394

  • Iqbal N, Iqbal N. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014;2014:852748. doi: 10.1155/2014/852748. Epub 2014 Sep 7.

    PubMed 25276427

  • Harbeck N, Thomssen C. A new look at node-negative breast cancer. Oncologist. 2011;16 Suppl 1:51-60. doi: 10.1634/theoncologist.2011-S1-51.

    PubMed 21278441

  • Giuliano AE, Dale PS, Turner RR, Morton DL, Evans SW, Krasne DL. Improved axillary staging of breast cancer with sentinel lymphadenectomy. Ann Surg. 1995 Sep;222(3):394-9; discussion 399-401. doi: 10.1097/00000658-199509000-00016.

    PubMed 7677468

  • Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012 Oct 4;490(7418):61-70. doi: 10.1038/nature11412. Epub 2012 Sep 23.

    PubMed 23000897

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing The MagSense® HER2 Imaging Agent (MSH2IA) in people with HER2-positive Breast Cancer, run by Imagion Biosystems, Inc..

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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mohammad Eghtedari, M.D., Ph.D. (626-739-8446, meghtedari@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Level of Fe in blood (time frame: 24 hours post injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07885683, which also lists 12 linked publications.

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 21 Oct 2026.

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