Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0XFQVE
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| ADC Name |
SYSA1801
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| Synonyms |
SYSA1801; CPO102; EO-3021
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| Organization |
CSPC Innovation Pharmaceutical (Originator);Elevation Oncology
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
2
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| Structure |
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| Antibody Name |
Anti-CLDN18.2 mAb
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Antibody Info | ||||
| Antigen Name |
Claudin-18.2 (CLDN18.2)
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Antigen Info | ||||
| Payload Name |
MMAE
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
PEG3-Val-Cit-PABC
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Linker Info | ||||
| Conjugate Type |
Enzymatic Catalysis
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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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| Gastric cancer |
3 Trials
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| Gastroesophageal junction adenocarcinoma |
2 Trials
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| Lung cancer |
1 Trials
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| Pancreatic cancer |
2 Trials
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| Unspecific solid tumor |
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 |
Inclusion criteria for Parts A/B: histologically confirmed pancreatic/gastric/esophagogastric junction cancer with ≥50% tumor cells showing moderate-to-strong claudin 18.2 staining (IHC 2+/3+), archived/fresh tumor tissue, adequate organ function, life expectancy >12 weeks, age ≥18, ECOG PS 0/1, informed consent, and negative pregnancy test for reproductive-potential females within 48h prior to enrollment.
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| Administration Dosage |
Part A will follow the standard 3+3 dose-escalation design and will be enrolled at dose levels of CPO102 at (0.5, 1, 1.8, 2.5, 3.5, 4.5, 5.5 mg/kg).
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| Related Clinical Trial | |||||
| NCT Number | NCT05043987 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate Safety of CPO102, an Anti-claudin 18.2 Antibody-MMAE Drug Conjugate Administered Intravenously in Patients With Advanced Pancreatic and Gastric Cancers | ||||
| Primary Endpoint |
The study will assess the number of participants with dose-limiting toxicities (DLTs) during the DLT evaluation period (first 21-day cycle) to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), with data collected over an average of 3 years.
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| Other Endpoint |
Safety evaluations include treatment-emergent adverse events (TEAEs) graded by NCI-CTCAE v5.0 (Grade ≥3, serious, or fatal TEAEs with causality assessment), clinically significant changes in vital signs and lab tests, and CPO102 pharmacokinetics (AUC, Cmax, Tmax, t½, CL). Efficacy is measured by objective response rate (ORR per RECIST v1.1), while immunogenicity tracks anti-drug-antibody (ADA) incidence, all monitored over ~3 years.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
47.10
33.30 40.00 100.00 20.00 38.10 % |
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| Patients Enrolled |
Patients with resistant/refractory solid tumors that express CLDN18.2 who progressed on or were intolerant to standard treatment, or had no standard treatment were recruited.. ECOG score of 0-2.
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| Administration Dosage |
0.50 up to 3.00 mg/kg on day 1, administered once every 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT05009966 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1 trial to evaluate safety, tolerability, pharmacokinetics, immunogenicity and initial efficacy of SYSA1801 in the treatment of CLDN 18.2 positive advanced malignant solid tumor. | ||||
References