Payload Information

General Information of This Payload
Payload ID
PAY0CJNCU
Name
SHR9265
Synonyms
SHR9265
   Click to Show/Hide
Target(s) DNA topoisomerase 1 (TOP1)
 Target Info 
Structure
Formula
C29H28FN3O6
Isosmiles
CCC1(O)C(=O)OCc2c1cc1n(c2=O)Cc2c-1nc1cc(F)c(C)c3c1c2C(NC(=O)C(O)C1CC1)CC3
InChI
InChI=1S/C29H28FN3O6/c1-3-29(38)17-8-21-24-15(10-33(21)27(36)16(17)11-39-28(29)37)23-19(32-26(35)25(34)13-4-5-13)7-6-14-12(2)18(30)9-20(31-24)22(14)23/h8-9,13,19,25,34,38H,3-7,10-11H2,1-2H3,(H,32,35)
InChIKey
ODYAHADGPIHDQN-UHFFFAOYSA-N
Pharmaceutical Properties
Molecule Weight
533.556
Polar area
130.75
Complexity
39
xlogp Value
2.40152
Heavy Count
39
Rot Bonds
4
Hbond acc
8
Hbond Donor
3
Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
SHR-A1811 [Phase 3]
 ADC Info 
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  Phase 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  Phase 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  Phase 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  Phase 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  Phase 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  Phase 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  Phase 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  Phase 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  Phase 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  Phase 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  Phase 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  Phase 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  Phase 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.
SHR-A1921 [Phase 1/2]
 ADC Info 
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [14]
Related Clinical Trial
NCT Number NCT05765032  Phase Status Phase 1
Clinical Description
An open label, multicenter, phase 1b/2 study of SHR-A1921 in combination with other anti-cancer agents in patients with advanced solid tumors.
Experiment 2 Reporting the Activity Date of This ADC [15]
Related Clinical Trial
NCT Number NCT05594875  Phase Status Phase 1
Clinical Description
An open-label, multi-center phase 1 clinical study on the safety, tolerability, pharmacokinetics, and clinical activity of SHR-A1921 for injection in subjects with advanced solid tumors.
Experiment 3 Reporting the Activity Date of This ADC [16]
Related Clinical Trial
NCT Number NCT05154604  Phase Status Phase 1
Clinical Description
A phase 1 multi-center, open-label study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-a1921 in subjects with advanced malignant solid tumour.
SHR-A1904 [Phase 1/2]
 ADC Info 
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [17]
Related Clinical Trial
NCT Number NCT05277168  Phase Status Phase 1
Clinical Description
An open-label, single-arm, multi-center phase 1/2a clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1904 in subjects with advanced solid tumors.
Experiment 2 Reporting the Activity Date of This ADC [18]
Related Clinical Trial
NCT Number NCT04928625  Phase Status Phase 1
Clinical Description
An open-label, single-arm, multi-center phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1904 in patients with advanced pancreatic cancer.
Experiment 3 Reporting the Activity Date of This ADC [19]
Related Clinical Trial
NCT Number NCT04877717  Phase Status Phase 1
Clinical Description
An open-label, single-arm, multi-center phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1904 in patients with advanced solid tumors.
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
Ref 14 An Open Label, Multicenter, Phase Ib/II Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors, NCT05765032
Ref 15 An Open-Label, Multi-Center Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors, NCT05594875
Ref 16 A Phase 1 Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1921 in Subjects With Advanced Malignant Solid Tumour. NCT05154604
Ref 17 AN OPEN-LABEL, SINGLE-ARM, MULTI-CENTER PHASE I/IIA CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS, NCT05277168
Ref 18 An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1904 in Patients With Advanced Pancreatic Cancer, NCT04928625
Ref 19 An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1904 in Patients With Advanced Solid Tumors, NCT04877717

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