Floatz Rating
BB65/100
Confidence
Indicative
Sponsor
MedSIR
Modality
monoclonal_antibody
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
65Indicative
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07494448CT.gov Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer | — | Not Yet Recruiting | — | — | — |
NCT07102381CT.gov A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer | — | Recruiting | — | — | — |
NCT06435429CT.gov A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer | — | Recruiting | — | — | — |
NCT06253871CT.gov A Phase 1/1b Study of IAM1363 in HER2 Cancers | — | Recruiting | — | — | — |
NCT05868226CT.gov PRE-I-SPY Phase I/Ib Oncology Platform Program | — | Recruiting | — | — | — |
NCT05035836CT.gov A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC) | — | Recruiting | — | — | — |
NCT01042379CT.gov I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer | — | Recruiting | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · HER2 Positive Breast Carcinoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Zanidatamab (this asset) | MedSIR | P3 | BB · 65 |
| Trastuzumab | SWOG Cancer Research Network | P4 | BB |
| Pertuzumab | SWOG Cancer Research Network | P4 | BB |
| Ribociclib | Danish Breast Cancer Cooperative Group | P3 | BB |
| Vinorelbine Ditartrate | Fudan University | P3 | BB |
| Docetaxel | Ohio State University Comprehensive Cancer Center | P3 | BB |
| Capecitabine | MedSIR | P4 | BB |
| Cyclophosphamide | National University Hospital, Singapore | P3 | BB |
| gb221 | Genor Biopharma Co., Ltd. | P3 | BB |
+42 more in the HER2 Positive Breast Carcinoma cohort
Other indications for Zanidatamab
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Breast Carcinoma | — | P2 | BB · 64 |
| Gastric Neoplasm | — | P3 | B · 60 |
| Neoplasm | — | P2 | B · 60 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Zanidatamab in HER2 Positive Breast Carcinoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/zanidatamab-her2-positive-breast-carcinoma
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