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DRUG CLASS:

HER2-targeted antibody-drug conjugate

1d
ADAPTHER2-IV: NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer (clinicaltrials.gov)
P2, N=702, Recruiting, West German Study Group | Active, not recruiting --> Recruiting | N=402 --> 702 | Trial completion date: Jun 2029 --> Sep 2030 | Trial primary completion date: Jun 2025 --> Jun 2030
Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2)
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carboplatin • docetaxel • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki)
1d
Statins enhance trastuzumab deruxtecan efficacy: preclinical synergy in HER2-negative models and clinical benefit in HER2-positive metastatic breast cancer. (PubMed, Exp Hematol Oncol)
Our findings revealed that statin use significantly enhanced the efficacy of T-DXd in both a preclinical HER2-negative rat model and patients with HER2-positive mBC. Prospective clinical trials are warranted to validate these observations.
Preclinical • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 negative • HER-2 expression
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Enhertu (fam-trastuzumab deruxtecan-nxki)
1d
Antibody-drug conjugates in breast cancer brain and leptomeningeal metastases: mechanistic insights and therapeutic progress. (PubMed, Cancer Metastasis Rev)
In these studies, trastuzumab deruxtecan, a HER2-targeted ADC, demonstrated notable intracranial responses in patients with active CNS disease, suggesting that CNS barriers are dynamically remodeled within the tumor microenvironment to permit drug access...By integrating emerging clinical evidence with key pharmacological determinants and tumor-associated microenvironmental changes, this review delineates the mechanisms governing ADC activity in brain metastases and identifies critical factors underlying intracranial response. Collectively, these insights provide a mechanistic framework to guide the rational design of next-generation ADCs and optimize therapeutic strategies for patients with advanced CNS involvement.
Review • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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Enhertu (fam-trastuzumab deruxtecan-nxki)
2d
Trastuzumab Deruxtecan as a Salvage Therapy after Disitamab Vedotin Failure in HER2 Altered Solid Tumors: A Preliminary Real-world Comparative Study. (PubMed, Pak J Med Sci)
DS-8201 demonstrates potential as one of the effective salvage therapies following RC48 failure in HER2 altered solid tumors, showing significantly better disease control and a distinct, manageable toxicity profile. These findings highlight the importance of selecting personalized ADCs based on molecular subtypes and toxicity factors and provide a basis for future, larger-scale prospective studies.
Journal • Real-world evidence
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 mutation • HER-2 exon 20 insertion • HER-2 exon 20 mutation
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Enhertu (fam-trastuzumab deruxtecan-nxki) • Aidixi (disitamab vedotin)
2d
First-line durvalumab in combination with trastuzumab deruxtecan in women with locally advanced unresectable or metastatic, hormone-receptor-negative, HER2-low breast cancer: multicenter, open-label, phase 1b/2 BEGONIA platform trial. (PubMed, Nat Cancer)
Durvalumab plus T-DXd demonstrated clinically relevant efficacy for first-line treatment of metastatic HR-negative, HER2-low breast cancer, with no unexpected toxicities observed. ClinicalTrials.gov identifier: NCT03742102 .
P1/2 data • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HR negative
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Imfinzi (durvalumab) • Enhertu (fam-trastuzumab deruxtecan-nxki)
2d
Clinical Studies of TQB2930 Injection for the Treatment of Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=178, Recruiting, Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 expression • HER-2 underexpression
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TQB2102 • TQB2930
4d
Integrated metabolomics of tumor and plasma reveals local and systemic metabolic responses to T-DM1 therapy. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci)
These bidirectional changes indicate a metabolic coupling between tumor and circulation, driven by differential utilization and excretion processes during T-DM1 response. Collectively, our findings demonstrate that T-DM1 elicits coordinated local and systemic metabolic reprogramming, providing mechanistic insights into its antitumor activity and the metabolic coupling between tumor and circulation.
Journal • Metabolomic study
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HER-2 (Human epidermal growth factor receptor 2)
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EGFR positive
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Kadcyla (ado-trastuzumab emtansine)
5d
A Study of DS-8201a in Children, Adolescents, or Young Adults With recurrent Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor (clinicaltrialsregister.eu)
P1/2, N=55, National Institutes of Health, National Cancer Institute, Division of Cancer Treatment and Diagnosis
New P1/2 trial
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Enhertu (fam-trastuzumab deruxtecan-nxki)
5d
Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer (clinicaltrials.gov)
P2, N=100, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
New P2 trial
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HER-2 positive
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Enhertu (fam-trastuzumab deruxtecan-nxki) • trastuzumab rezetecan (SHR-A1811)
5d
Efficacy and safety of disitamab vedotin in treatment of advanced gastric cancer based on real-world. (PubMed, Front Oncol)
In the real-world setting, RC48 shows some clinical efficacy and a manageable safety profile in patients with HER2-expressing advanced gastric cancer. These findings provide useful information for clinical practice.
Journal • Real-world evidence
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 expression
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Aidixi (disitamab vedotin)
5d
New P2 trial
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
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HER-2 overexpression • HER-2 amplification
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Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811) • Idafang (ivonescimab)
6d
SHR-A1811-105: Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer (clinicaltrials.gov)
P1, N=17, Completed, Jiangsu HengRui Medicine Co., Ltd. | N=32 --> 17 | Trial completion date: Aug 2026 --> Oct 2025 | Trial primary completion date: Jun 2025 --> Oct 2025 | Recruiting --> Completed
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
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trastuzumab rezetecan (SHR-A1811) • itraconazole • ritonavir