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

NCT07885683 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IBI010105
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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 by subareolar or peritumoral injection. No hypothesis testing is planned. Comparative statistics will be used to generate hypotheses to be tested in subsequent studies.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Phase 1b: Level of Fe in blood

  PK MSH2IA Fe concentration \> LLOQ in human whole blood

  24 hours post injection

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

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

  24 hours post injection

• 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).

  24 hours post injection

Secondary Outcomes (1)

• Safety and Tolerability of MSH2IA Across All Phases

  From baseline through 1 year

Study Arms (2)

Phase 1b - MSH2IA Pharmacokinetics

EXPERIMENTAL

Participants enrolled in Phase 1b will receive MSH2IA to evaluate its pharmacokinetic (PK) profile.

Combination Product: The MagSense® HER2 Imaging Agent (MSH2IA)

Phase 2 - MSH2IA Dose and Diagnostic Performance

EXPERIMENTAL

Participants 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.

Combination Product: The MagSense® HER2 Imaging Agent (MSH2IA)

Interventions

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.

Phase 1b - MSH2IA Pharmacokinetics; Phase 2 - MSH2IA Dose and Diagnostic Performance

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Imagion Biosystems, Inc.: lead
• City of Hope National Medical Center: collaborator

Related Publications (12)

• 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.

  PMID: 20194857 BACKGROUND

• 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.

  PMID: 12904519 BACKGROUND

• 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.

  PMID: 2470152 BACKGROUND

• 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.

  PMID: 3798106 BACKGROUND

• 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.

  PMID: 17330229 BACKGROUND

• 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.

  PMID: 39208532 BACKGROUND

• 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.

  PMID: 10963602 BACKGROUND

• 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.

  PMID: 20498394 BACKGROUND

• 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.

  PMID: 25276427 BACKGROUND

• 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.

  PMID: 21278441 BACKGROUND

• 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.

  PMID: 7677468 BACKGROUND

• 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.

  PMID: 23000897 BACKGROUND

Central Study Contacts

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

CONTACT

626-739-8446; meghtedari@coh.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants are assigned to a single intervention group and receive MSH2IA for diagnostic imaging.

Study Record Dates

• First Submitted: October 13, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): July 23, 2029
• Last Updated: October 21, 2026

Record last verified: 2026-10