Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0JVAJA
ADC Name
Rosopatamab tetraxetan
Synonyms
DOTA-HUJ-591-GS; DOTA-HUJ-591; HuJ591-DOTA; Rosopatamab Y-90 conjugation
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Organization
Weill Cornell Medical Center
Drug Status
Clinical candidate
Indication
In total 1 Indication(s)
Prostate cancer [ICD11:2C82]
Clinical candidate
Drug-to-Antibody Ratio
3-5
Antibody Name
Rosopatamab
  Antibody Info 
Antigen Name
Glutamate carboxypeptidase 2 (FOLH1)
  Antigen Info 
Payload Name
Y90 (Radioactive isotope)
  Payload Info 
Linker Name
Tetraxetan
  Linker Info 
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Objective Response Rate (ORR)  NCT02576548
Phase 1
A phase 1/2 multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, pharmacokinetics, immunogencity, and antitumor activity of MEDI4276 in subjects with select HER2-expressing advanced solid tumors.

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Undisclosed  NCT00070837
Phase 1
A phase 1/2 dose escalation trial of multiple doses of mLN2704 (DM1 conjugated monoclonal antibody mLN591) in subjects with metastatic androgen-independent prostate cancer.
Undisclosed  NCT00052000
Phase 1
Phase 1 dose-escalation study of intravenous CMD-193 in subjects with advanced malignant solid tumors.
Full List of Activity Data of This Antibody-drug Conjugate
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 [1]
Efficacy Data Objective Response Rate (ORR)
9.38% (breast cancer)
0.00% (gastric cancer)
Patients Enrolled
Unresectable, locally advanced or metastatic breast cancer or gastric cancer refractory to standard therapy.
Administration Dosage
Intravenously over 60 to 90 minutes at 0.05, 0.10, 0.20, 0.30, 0.40, 0.50, 0.60, 0.75, or 0.90 mg/kg every 3 weeks.
Related Clinical Trial
NCT Number NCT02576548  Clinical Status Phase 1
Clinical Description A phase 1/2 multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, pharmacokinetics, immunogencity, and antitumor activity of MEDI4276 in subjects with select HER2-expressing advanced solid tumors.
Primary Endpoint
In patients with breast cancer,ORR=9.38% (N=3/32),DOR=4.20-10.20 months. In the 0.05 to 0.40 mg/kg cohort,PFS=1.3-2.0 months. In the 0.50 to 0.75 mg/kg cohort,PFS=4.60-15.40 months. median overall survival (OS)=19.10 months (range 0.80-30.60, 95% CI 9.6-NA).
Other Endpoint
No objective responses in patients with gastric cancer,median PFS=1.80 months (range 0-10.7, 95% CI,1.3-3.0),median OS=6.50 months (range 2.80-16.30, 95% CI, 3.10-16.30).
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT00070837  Clinical Status Phase 1
Clinical Description A phase 1/2 dose escalation trial of multiple doses of mLN2704 (DM1 conjugated monoclonal antibody mLN591) in subjects with metastatic androgen-independent prostate cancer.
Experiment 3 Reporting the Activity Date of This ADC [3]
Related Clinical Trial
NCT Number NCT00052000  Clinical Status Phase 1
Clinical Description Phase 1 dose-escalation study of intravenous CMD-193 in subjects with advanced malignant solid tumors.
References
Ref 1 First-in-Human, Phase 1 Dose-Escalation Study of Biparatopic Anti-HER2 Antibody-Drug Conjugate MEDI4276 in Patients with HER2-positive Advanced Breast or Gastric Cancer. Mol Cancer Ther. 2021 Aug;20(8):1442-1453.
Ref 2 Phase 1/2 multiple ascending dose trial of the prostate-specific membrane antigen-targeted antibody drug conjugate MLN2704 in metastatic castration-resistant prostate cancer. Urol Oncol. 2016 Dec;34(12):530.e15-530.e21.
Ref 3 A Trial of MLN2704 in Subjects With Metastatic Androgen Independent Prostate Cancer; NCT00052000

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