Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0VBVDR
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| ADC Name |
ADCT-502
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| Synonyms |
ADCT-502
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| Organization |
ADC Therapeutics (Originator)
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
1.7
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| Structure |
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| Antibody Name |
Trastuzumab variant
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Antibody Info | ||||
| Antigen Name |
Receptor tyrosine-protein kinase erbB-2 (HER2 ECD2); Receptor tyrosine-protein kinase erbB-2 (HER2 ECD4)
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Antigen Info | ||||
| Payload Name |
SG3199 (SC-DR002)
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Payload Info | ||||
| Therapeutic Target |
Human deoxyribonucleic acid (hDNA)
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Target Info | ||||
| Linker Name |
Mal-PEG8-Val-Ala-PABC
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Linker Info | ||||
| Conjugate Type |
Reactive Cysteines
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| Combination Type |
tesirine
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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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| Gastroesophageal junction adenocarcinoma |
1 Trials
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| Lung cancer |
1 Trials
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| Unspecific solid tumor |
1 Trials
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| Urothelial 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] | ||||
| Patients Enrolled |
Key eligibility: Adults (≥18) with HER2+ metastatic solid tumors, ECOG 0-2 (dose escalation)/0-1 (expansion), adequate organ function (ANC≥1500, platelets≥100K, bilirubin≤1.5×ULN, CrCl≥60). Exclusions: Grade≥3 antibody hypersensitivity, CNS metastases, active HBV/HCV/HIV, recent anticancer therapy, pregnancy, or uncontrolled comorbidities.
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| Administration Dosage |
Part 1 (dose escalation): Participants received an infusion of ADCT-502, at escalating doses. Part 1 continued until the maximum tolerated dose or the recommended dose (s) and schedule (s) for expansion were determined.Part 2 (expansion): Participants were due to be assigned to the recommended dose level of ADCT-502 as identified in Part 1 by the Dose Escalation Steering Committee.
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| Related Clinical Trial | |||||
| NCT Number | NCT03125200 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-502 in Patients With Advanced Solid Tumors With HER2 Expression | ||||
| Primary Endpoint |
Primary endpoints include DLT assessment (Grade ≥3 per CTCAE v4) during first 21-day cycle, TEAE/SAE monitoring through treatment +30 days, and comprehensive safety evaluations (labs, physical exams, ECOG status, vitals, ECG).
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| Other Endpoint |
Secondary objectives cover tumor response (ORR/DCR/DOR/PFS/OS assessed q12w per RECIST 1.1), PK analysis (AUC/Cmax/Tmax for total antibody, DAR≥0 species, PBD-conjugated antibody, free warhead SG3199), and immunogenicity (ADA titers).
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
20%
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| Patients Enrolled |
Patients with HER2-positive advanced solid tumors.
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| Administration Dosage |
Seven dose cohorts (30, 60, 120, 150, 180, 210, 240 ug/kg on day 1, iv once every 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT03125200 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ADCT-502 in patients with advanced solid tumors with HER2 expression. | ||||
References