Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0CECRA
ADC Name
SHR-A1811
Synonyms
SHR A1811; SHR-A1811; SHRA1811
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Organization
Jiangsu Hengrui Pharmaceuticals Co., Ltd.; Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Drug Status
Phase 3
Indication
In total 10 Indication(s)
HER2(+) breast cancer [ICD11:2C60-2C65]
Phase 3
HER2(low) breast cancer [ICD11:2C60-2C65]
Phase 3
Breast cancer [ICD11:2C60-2C65]
Phase 2
HER2(+) gastric cancer [ICD11:2B72]
Phase 2
HER2(+) gastroesophageal junction cancer [ICD11:2B71]
Phase 2
Solid tumors [ICD11:2A00-2A0Z|2B50-2F9Z]
Phase 2
Colorectal cancer [ICD11:2B91]
Phase 1
Gastric cancer [ICD11:2B72]
Phase 1
Gastroesophageal junction cancer [ICD11:2B71]
Phase 1
Non-small cell lung cancer [ICD11:2C25]
Phase 1
Drug-to-Antibody Ratio
5.7
Structure
Antibody Name
Trastuzumab
  Antibody Info 
Antigen Name
Receptor tyrosine-protein kinase erbB-2 (ERBB2)
  Antigen Info 
Payload Name
SHR9265
  Payload Info 
Therapeutic Target
DNA topoisomerase 1 (TOP1)
  Target Info 
Linker Name
Mc-Gly-Gly-Phe-Gly
  Linker Info 
Conjugate Type
Random conjugation through reduced inter-chain cysteines.
Special Approval(s)
Breakthrough therapy(NMPA); Special approval (NMPA)
Puchem SID
474492553 , 471299241
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 13 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Objective Response Rate (ORR)  NCT04446260
Phase 1
A phase 1 multi-country, multi-center, open-label study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A1811 in HER2 expressing or mutated advanced malignant solid tumor subjects.

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Undisclosed  NCT05424835
Phase 3
A phase 3, multicenter, randomized, open-label, parallel controlled study of SHR-A1811 versus pyrotinib in combination with capecitabine for HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

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Undisclosed  NCT05769010
Phase 2
A prospective, open-label explorative study of SHR-A1811 in HER2-expression advanced breast cancer with brain metastases.
Undisclosed  NCT05749588
Phase 2
Precision platform study of refractory triple-negative breast cancer based on molecular subtyping (a phase 2, open-label, single-center platform study).
Undisclosed  NCT05671822
Phase 2
A phase 1b/2 study of SHR-A1811 combinations in patients with advanced/metastatic HER2+ gastric /gastroesophageal junction adenocarcinoma.
Undisclosed  NCT05635487
Phase 2
A single-arm, phase 2 study of SHR-A1811 combined with pyrotinib maleate as neoadjuvant treatment in HER2-positive breast cancer patients.
Undisclosed  NCT05594095
Phase 2
Precision platform study of HR+/ HER2-advanced breast cancer based on snf typing (a prospective, open-label, multi-center, phase 2 platform study).
Undisclosed  NCT05353361
Phase 2
A phase 1b/2 multicenter, open-label clinical trial of SHR-A1811 injection in combination with pyrotinib or pertuzumab or SHR-1316 or paclitaxel for injection (albumin bound) in HER2-positive breast cancer.

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Undisclosed  NCT05349409
Phase 2
A phase 1b/2 clinical study on the dosage exploration and efficiency expansion of SHR-A1811 for injection in combination with fluzoparib capsule in HER2-expressing advanced solid tumors of patients.
Undisclosed  NCT05582499
Phase 1/2
Fudan university shanghai cancer center breast cancer precision platform series study- neoadjuvant therapy (FASCINATE-N).
Undisclosed  NCT05482568
Phase 1/2
Phase 1B/2 clinical study of the safety, tolerability, pharmacokinetics, and efficacy of injectable SHR-A1811 in combination with pyrotinib or SHR-1316 in subjects with advanced non-small cell lung cancer with HER2.

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Undisclosed  NCT04818333
Phase 1/2
Phase 1/2 clinical study of the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression, amplification, or mutation.

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Undisclosed  NCT04513223
Phase 1
Safety, tolerability, pharmacokinetics, and antitumour activity of SHR-A1811, in patients with HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer: a phase 1 study.

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Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 13 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Objective Response Rate (ORR)
61.60%
81.50% (HER2-positive BC)
55.80% (HER2-low BC)
Patients Enrolled
Pts were eligible if they had HER2 positive breast cancer (BC), HER2 positive gastric/GEJ carcinoma, HER2 low-expressing BC, HER2-expressing/mutated NSCLC, or other HER2-expressing/mutated solid tumors, and were refractory or intolerant to standard therapy.
Administration Dosage
SHR-A1811 at doses of 1.00-8.00 mg/kg was given Q3W (IV).
Related Clinical Trial
NCT Number NCT04446260  Clinical Status Phase 1
Clinical Description A phase 1 multi-country, multi-center, open-label study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A1811 in HER2 expressing or mutated advanced malignant solid tumor subjects.
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT05424835  Clinical Status Phase 3
Clinical Description A phase 3, multicenter, randomized, open-label, parallel controlled study of SHR-A1811 versus pyrotinib in combination with capecitabine for HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
Experiment 3 Reporting the Activity Date of This ADC [3]
Related Clinical Trial
NCT Number NCT05769010  Clinical Status Phase 2
Clinical Description A prospective, open-label explorative study of SHR-A1811 in HER2-expression advanced breast cancer with brain metastases.
Experiment 4 Reporting the Activity Date of This ADC [4]
Related Clinical Trial
NCT Number NCT05749588  Clinical Status Phase 2
Clinical Description Precision platform study of refractory triple-negative breast cancer based on molecular subtyping (a phase 2, open-label, single-center platform study).
Experiment 5 Reporting the Activity Date of This ADC [5]
Related Clinical Trial
NCT Number NCT05671822  Clinical Status Phase 2
Clinical Description A phase 1b/2 study of SHR-A1811 combinations in patients with advanced/metastatic HER2+ gastric /gastroesophageal junction adenocarcinoma.
Experiment 6 Reporting the Activity Date of This ADC [6]
Related Clinical Trial
NCT Number NCT05635487  Clinical Status Phase 2
Clinical Description A single-arm, phase 2 study of SHR-A1811 combined with pyrotinib maleate as neoadjuvant treatment in HER2-positive breast cancer patients.
Experiment 7 Reporting the Activity Date of This ADC [7]
Related Clinical Trial
NCT Number NCT05594095  Clinical Status Phase 2
Clinical Description Precision platform study of HR+/ HER2-advanced breast cancer based on snf typing (a prospective, open-label, multi-center, phase 2 platform study).
Experiment 8 Reporting the Activity Date of This ADC [8]
Related Clinical Trial
NCT Number NCT05353361  Clinical Status Phase 2
Clinical Description A phase 1b/2 multicenter, open-label clinical trial of SHR-A1811 injection in combination with pyrotinib or pertuzumab or SHR-1316 or paclitaxel for injection (albumin bound) in HER2-positive breast cancer.
Experiment 9 Reporting the Activity Date of This ADC [9]
Related Clinical Trial
NCT Number NCT05349409  Clinical Status Phase 2
Clinical Description A phase 1b/2 clinical study on the dosage exploration and efficiency expansion of SHR-A1811 for injection in combination with fluzoparib capsule in HER2-expressing advanced solid tumors of patients.
Experiment 10 Reporting the Activity Date of This ADC [10]
Related Clinical Trial
NCT Number NCT05582499  Clinical Status Phase 1/2
Clinical Description Fudan university shanghai cancer center breast cancer precision platform series study- neoadjuvant therapy (FASCINATE-N).
Experiment 11 Reporting the Activity Date of This ADC [11]
Related Clinical Trial
NCT Number NCT05482568  Clinical Status Phase 1/2
Clinical Description Phase 1B/2 clinical study of the safety, tolerability, pharmacokinetics, and efficacy of injectable SHR-A1811 in combination with pyrotinib or SHR-1316 in subjects with advanced non-small cell lung cancer with HER2.
Experiment 12 Reporting the Activity Date of This ADC [12]
Related Clinical Trial
NCT Number NCT04818333  Clinical Status Phase 1/2
Clinical Description Phase 1/2 clinical study of the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression, amplification, or mutation.
Experiment 13 Reporting the Activity Date of This ADC [13]
Related Clinical Trial
NCT Number NCT04513223  Clinical Status Phase 1
Clinical Description Safety, tolerability, pharmacokinetics, and antitumour activity of SHR-A1811, in patients with HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer: a phase 1 study.
References
Ref 1 A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects, NCT04446260
Ref 2 A Phase III, Multicenter, Randomized, Open-Label, Parallel Controlled Study of SHR-A1811 Versus Pyrotinib in Combination With Capecitabine for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane, NCT05424835
Ref 3 A Prospective, Open-label Explorative Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases, NCT05769010
Ref 4 Precision Platform Study of Refractory Triple-negative Breast Cancer Based on Molecular Subtyping(A Phase II, Open-label, Single-center Platform Study, NCT05749588
Ref 5 A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2+ Gastric /Gastroesophageal Junction Adenocarcinoma, NCT05671822
Ref 6 A Single-arm, Phase II Study of SHR-A1811 Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients, NCT05635487
Ref 7 Precision Platform Study of HR+/ HER2-advanced Breast Cancer Based on SNF Typing (A Prospective, Open-label, Multi-center, Phase II Platform Study), NCT05594095
Ref 8 A Phase Ib/II Multicenter, Open-Label Clinical Trial of SHR-A1811 Injection in Combination With Pyrotinib or Pertuzumab or SHR-1316 or Paclitaxel for Injection (Albumin Bound) in HER2-Positive Breast Cancer, NCT05353361
Ref 9 A Phase b/ Clinical Study on the Dosage Exploration and Efficiency Expansion of SHR-A1811 for Injection in Combination With Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients, NCT05349409
Ref 10 Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N), NCT05582499
Ref 11 Phase IB/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer With HER2, NCT05482568
Ref 12 Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1811 for Injection in Subjects With Advanced Non-small Cell Lung Cancer Who Have HER2 Expression , Amplification, or Mutation, NCT04818333
Ref 13 Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of SHR-A1811, in Patients With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: a Phase 1 Study, NCT04513223

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