Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0JNZLF
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| ADC Name |
PCA062
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| Synonyms |
PCA062; NOV-10
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| Organization |
MorphoSys (Top20 MNC) (Originator);Novartis (Top20 MNC);ImmunoGen (Top20 MNC)
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
3.8
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| Structure |
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| Antibody Name |
CQY684
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Antibody Info | ||||
| Antigen Name |
Cadherin-3 (CDH3)
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Antigen Info | ||||
| Payload Name |
DM1
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Succinimidyl-4-(N-maleimidomethyl)cyclohexane-1-carboxylate (SMCC)
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Linker Info | ||||
| Conjugate Type |
Random Lysines
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| Combination Type |
emtansine
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||
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| Breast cancer |
1 Trials
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| Head and neck cancer |
1 Trials
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| Oesophageal cancer |
1 Trials
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease Control Rate (DCR) |
22.60
33.30 22.20 % |
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| 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).
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| 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.
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| 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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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | progressive disease (PD) |
78.70%
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| Patients Enrolled |
Eligible patients are ≥18 years old with progressive pCAD+ tumors (excluding HNSCC/ESCC), measurable disease per RECIST v1.1, and ECOG ≤2, with mandatory biopsy consent. Exclusions cover CNS metastases, significant comorbidities, prior pCAD-targeting biologics, recent anticancer treatments (4 weeks for chemotherapy/biologics, 2 weeks for surgery), and abnormal lab values (ANC <1.5, Hgb <9, platelets <100, hepatic/renal dysfunction). Vision-related risks also preclude participation.
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| Administration Dosage |
Forty-seven patients were treated at 10 different dose levels of PCA062, ranging from 0.4 to 5.0 mg/kg every 2 weeks administered as a 1-hour intravenous infusion.
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| Related Clinical Trial | |||||
| NCT Number | NCT02375958 | Clinical Status | PHASE1 | ||
| 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 study evaluates the incidence of dose-limiting toxicities (DLTs) within the first 28 days to determine the safety and tolerability of PCA062, establishing a critical early assessment of potential treatment-related severe adverse effects.
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| Other Endpoint |
Key safety and efficacy measures include incidence/severity of adverse events, pharmacokinetic parameters (Cmax, Tmax), and immunogenicity (anti-PCA062 antibodies) over 84 days. Clinical endpoints such as overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and disease control rate (DCR) are monitored throughout treatment cycles (14-day intervals) and up to 18 months to assess therapeutic efficacy.
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References