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Association details:
| Biomarker: | HER-2 expression |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | Aidixi (disitamab vedotin) (Microtubule inhibitor, HER2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Prospective, Single-Arm Phase II Study of Disitamab Vedotin (RC48-ADC) for Early High-Risk or Locally Advanced Estrogen Receptor-Positive/HER2-Low Breast Cancer Treatment
Excerpt:
...Pathologically confirmed HER2 low expression (defined as immunohistochemistry [IHC] 2+, in situ hybridization [ISH]- or IHC 1+); 5. ...
Trial ID:
Source:
Title:
A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
Excerpt:
...- HER2 expression of 1+, 2+, or 3+, as determined by local IHC testing on a fresh or archival tumor tissue...
Trial ID:
More C2 evidence
Source:
Title:
A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
Excerpt:
...- HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample...
Trial ID:
Source:
Title:
Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer
Excerpt:
...tumor tissue blocks (or fresh tissue sections, see laboratory manuals) obtained from locally recurrent lesions for biomarker analysis, including HER2 expression and HR status....
Trial ID:
Source:
Title:
A Study of RC48-ADC Combined With JS001 For Perioperative Treatment of Muscle-Invasive Bladder Cancer
Excerpt:
...- HER2 expressing (i.e. IHC 1+ 2+ or 3+) as confirmed by the local lab....
Trial ID:
Source:
Title:
A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases
Excerpt:
...- Positive HER2 expression (positive defined as: IHC 3+ or FISH+); previous test results of HER2 expression provided by the subjects (have to be confirmed by the investigator) and those obtained from the study site or the central laboratory were both acceptable; subject are able to provide samples from primary or metastatic tumor sites for HER2 test (either paraffin blocks, paraffin-embedded sections, or sections prepared using freshly excised tissues);...
Trial ID:
Source:
Title:
A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma
Excerpt:
...- HER2-expressing status determined by the central laboratory to be IHC 1+, 2+ or 3+....
Trial ID:
Source:
Title:
A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer
Excerpt:
...- HER2-expressing status determined by laboratory to be IHC 1+, 2+ or 3+....
Trial ID:
Source:
Title:
RC48-ADC Combined With Radiotherapy in the Treatment of Locally Advanced Solid Tumors With HER2 Expression
Excerpt:
...HER2 expression is confirmed by the site: IHC 1+, 2+or 3+; 7....
Trial ID:
Source:
Title:
RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder Cancer
Excerpt:
...- Have tumor tissues for HER2 IHC evaluation and have a HER2 expression score of HER2 2+ or HER2 3+ reviewed by an independent pathologist at the central laboratory....
Trial ID:
Source:
Title:
Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial)
Excerpt:
...Pathological examination confirmed that ER and / or PR were positive, and HER-2 was low expression (...
Trial ID:
Source:
Title:
The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression
Excerpt:
...0-1; 5）Patients with low expression of HER-2: HER-2 IHC 1+or HER2 IHC 2+and ISH negative;...
Trial ID:
Source:
Title:
Study of Disitamab Vedotin Combined With Gemcitabine in Neoadjuvant Treatment of Urothelial Carcinoma
Excerpt:
...Pathologically, it is urothelial carcinoma, and the patient has HER2 expression and refuses neoadjuvant chemotherapy or physical condition/renal function [glomerular filtration rate (GFR) 30-60mL/min], which is...
Trial ID:
Source:
Title:
A Study of RC48-ADC for the Treatment of HER2-expression Metastatic Breast Cancer With Abnormal Activation of PAM Pathway
Excerpt:
...HER2 expression (positive defined as: IHC 3+ or FISH+ and low expression defined as: IHC2+and FISH- or IHC 1+); previous test results of HER2 expression provided by the subjects (have to be confirmed by the investigator) and those obtained from the study site or the central laboratory were both acceptable; 5....
Trial ID:
Source:
Title:
A Multicenter, Prospective, Open-Label Study of Disitamab Vedotin in Neoadjvant Treatment of HER2 Positive Breast Cancer With Poor Early Efficacy
Excerpt:
...The histopathological examination confirmed that HER2 expression was positive, and the clinical staging was stage II-III [cT2 and any N, cT3 and any N; cT4 and any N, according to the standards of the American Joint Commission on Cancer (AJCC)] invasive breast cancer patients. ...
Trial ID:
Source:
Title:
Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
Excerpt:
...- HER2 expression of 1+ or greater on immunohistochemistry (IHC)....
Trial ID:
Source:
Title:
Evaluating the Safety and Tolerability of Intravesical Instillation of Disitamab Vedotin (DV; RC48-ADC) for the Treatment of HER2-Expressing Non-Muscle Invasive Bladder Cancer (NMIBC) in High-Risk Bacillus Calmette-Guérin (BCG)-Naive or BCG-Non-Responsive Patients: An Open-Label, Single-Arm, Single-Center Clinical Trial.
Excerpt:
...Tumor tissue samples obtained from the subject via TURBT within 3 weeks should demonstrate HER2 expression of 1+, 2+, or 3+ upon immunohistochemistry (IHC) testing. ...
Trial ID:
Source:
Title:
An Exploratory Clinical Study of Neoadjuvant Disitamab Vedotin Therapy for Muscler-Invasive Urothelial Bladder Cancer with HER2 Overexpression
Excerpt:
...Histopathologically confirmed urothelial carcinoma of the bladder, mixed carcinoma requiring the urothelial carcinoma subtype as the predominant histological type, with immunohistochemical HER2 expression of 2+ or above; 6. ...
Trial ID:
Source:
Title:
A prospective, open, single-arm Phase II clinical study of vidisetuzumab for injection in patients with her2-expressed locally advanced or metastatic malignant solid tumors
Excerpt:
...The specimen of the primary or metastatic lesion of the subject was confirmed by the Department of Pathology of our hospital as HER2 expression (HER2 expression is defined as IHC1+, 2+, or 3+); 3. ...
Trial ID:
Less C2 evidence
Source:
Title:
RC48-ADC treatment for patients with HER2-expressing locally advanced or metastatic solid tumors: a real-world study
Published date:
11/09/2023
Excerpt:
RC48-ADC shows promising efficacy and manageable safety in HER2-expressing advanced or metastatic solid tumor patients.
DOI:
10.1186/s12885-023-11593-9
