Floatz Rating
B61/100
Confidence
Indicative
Sponsor
Fudan University
Modality
antibody_drug_conjugate
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
63High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07366840CT.gov RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure | — | Not Yet Recruiting | — | — | — |
NCT06966453CT.gov A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer | — | Recruiting | — | — | — |
NCT06642545CT.gov Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer | — | Recruiting | — | — | — |
NCT06157892CT.gov A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors | — | Recruiting | — | — | — |
NCT06389006CT.gov To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer | — | Recruiting | — | — | — |
NCT07446452CT.gov Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study | — | Recruiting | — | — | — |
NCT06178159CT.gov DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer | — | Recruiting | — | — | — |
NCT06001086CT.gov A Phase II Clinical Study of Treatment With Disitamb Vedotin Plus Pyrotinib in HER2-positive Early Breast Cancer | — | Recruiting | — | — | — |
NCT06015113CT.gov Efficacy and Safety of Disitamab Vedotin Plus Pyrotinib or Naratinib in HER2-positive Breast Cancer Patients With Brain Metastasis | — | Not Yet Recruiting | — | — | — |
NCT06000033CT.gov Study of Disitamab Vedotin and Anlotinib in Patients With HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer | — | Unknown | — | — | — |
Show 12 more trialsShow fewer
NCT06227117CT.gov Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer | — | Recruiting | — | — | — |
NCT05851677CT.gov Disitamab Vedotin (RC48-ADC) in Breast Cancer | — | Recruiting | — | — | — |
NCT05831878CT.gov RC48-ADC in HER2-low Advanced Breast Cancer | — | Recruiting | — | — | — |
NCT05726175CT.gov Disitamab Vedotin(RC48) Combined With Penpulimab(AK105) for Neoadjuvant Treatment of HER2-low Breast Cancer | — | Unknown | — | — | — |
NCT05861635CT.gov The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression | — | Unknown | — | — | — |
NCT05331326CT.gov A Study of RC48-ADC for the Treatment of HER2-expression Metastatic Breast Cancer With Abnormal Activation of PAM Pathway | — | Unknown | — | — | — |
NCT05134519CT.gov RC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer | — | Unknown | — | — | — |
NCT06168227CT.gov A Multicenter and Real-world Analysis of RC48-ADC in Patients With HER2-positive or HER2-low Expressing, Locally Advanced or Metastatic Breast Cancer | — | Completed | — | — | — |
NCT04734262CT.gov A Phase II Study to Explore the Safety, Tolerability, and Preliminary Antitumor Activity of Sitravatinib Plus Tislelizumab or Combination With Nab-paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC) | — | Unknown | — | — | — |
NCT04400695CT.gov A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2 | — | Unknown | — | — | — |
NCT04276493CT.gov Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab | — | Completed | — | — | — |
NCT03052634CT.gov A Study of RC48-ADC in Subjects With Advanced Breast Cancer | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Breast Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Disitamab Vedotin (this asset) | Fudan University | Approved | B · 61 |
| Darolutamide | Vandana Abramson | P2 | BBB |
| Pertuzumab | SWOG Cancer Research Network | P4 | BB |
| Palbociclib | Hoffmann-La Roche | P4 | BB |
| Trastuzumab Duocarmazine | Byondis B.V. | P3 | BB |
| Goserelin | TerSera Therapeutics LLC | P4 | BB |
| Ribociclib | National Cancer Institute (NCI) | P4 | BB |
| Oxaliplatin | Beijing Biostar Pharmaceuticals Co., Ltd. | P4 | BB |
| Eribulin Monomethanesulfonate | Henan Cancer Hospital | P4 | BB |
+42 more in the Breast Cancer cohort
Other indications for Disitamab Vedotin
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Gastroesophageal Junction Adenocarcinoma | — | P2 | BB · 67 |
| HER2 Positive Breast Carcinoma | — | P4 | BB · 64 |
| Colorectal Cancer | — | P4 | B · 61 |
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. Disitamab Vedotin in Breast Cancer. 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/disitamab-vedotin-breast-cancer
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