Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0JNZLF
ADC Name
PCA-062
Synonyms
PCA-pCAD; NOV-10; PCA062; PCA 062
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Drug Status
Terminated in phase 1
Indication
In total 2 Indication(s)
Esophageal cancer [ICD11:2B70]
Terminated in phase 1
Triple negative breast cancer [ICD11:2C60-2C65]
Terminated in phase 1
Drug-to-Antibody Ratio
3.8
Structure
Antibody Name
CQY684
  Antibody Info 
Antigen Name
Cadherin-3 (CDH3)
  Antigen Info 
Payload Name
Mertansine DM1
  Payload Info 
Therapeutic Target
Microtubule (MT)
  Target Info 
Linker Name
Succinimidyl-4-(N-maleimidomethyl)cyclohexane-1-carboxylate (SMCC)
  Linker Info 
Conjugate Type
Random conjugation through nucleophilic lysines.
Combination Type
Emtansine
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Disease Control Rate (DCR)  NCT02375958
Phase 1
A phase 1 multi-center, open-label dose escalation and expansion study of PCA062 administered intravenously in adult patients with p-CAD positive tumors.
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Disease Control Rate (DCR)
22.60% (31 patients with other tumors)
33.30% (HNSCC)
22.20% (esophageal cancer)
Patients Enrolled
Advanced solid tumors expressing P-cadherin, TNBC, head and neck squamous cell carcinoma (HNSCC), esophageal cancer, cervical cancer, and non-small cell lung cancer (NSCLC).
Administration Dosage
At 10 different dose levels of PCA062, ranging from 0.40 to 5.00 mg/kg every 2 weeks administered as a 1-hour intravenous infusion.
Related Clinical Trial
NCT Number NCT02375958  Clinical Status Phase 1
Clinical Description A phase 1 multi-center, open-label dose escalation and expansion study of PCA062 administered intravenously in adult patients with p-CAD positive tumors.
Primary Endpoint
The MTD was PCA062 3.60 mg/kg every 2 weeks.No patient achieved a complete response. Only 1 patient with stage IV metastatic HNSCC treated at 0.90 mg/kg achieved a confirmed partial response (PR) as best overall response (BOR). The disease control rate (DCR) for the 31 patients with other tumors was 22.60% (95% CI, 9.60-41.10). In patients with HNSCC (n = 6), DCR was 33.30% (95% CI, 4.30-77.70), and in patients with esophageal cancer (n = 9), DCR was 22.20% (95% CI, 2.80-60.00).

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References
Ref 1 A First-in-Human, Phase I, Multicenter, Open-Label, Dose-Escalation Study of PCA062: An Antibody-Drug Conjugate Targeting P-Cadherin, in Patients With Solid Tumors. Mol Cancer Ther. 2022 Apr 1;21(4):625-634.

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