Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0BAANV)
| ADC Name |
AbGn-7
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| Synonyms |
AbGn 7; AbGn-7; AbGn7
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| Organization |
AbGenomics International, Inc.
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| Drug Status |
Phase 1
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| Antibody Name |
Undisclosed
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| Antigen Name |
AG7
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Antigen Info | ||||
| Payload Name |
Undisclosed
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| Linker Name |
Undisclosed
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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
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 |
Eligible patients must be ≥18 years with ECOG ≤2; Phase 1a requires advanced epithelial solid tumors (failed prior chemo), Phase 1b requires recurrent/metastatic gastric cancer (chemo-naïve or failed prior chemo), with adequate organ function and life expectancy ≥3 months. Exclusions include CNS metastases, recent chemo/radiation/surgery, active infections, uncontrolled diabetes, significant cardiac history, or concurrent investigational therapies.
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| Administration Dosage |
Phase 1a: dose escalation; Drug: AbGn-7 weekly iv infusion Duration: 6 weeks; Phase 1b: two doses (one dose below MTD/MAD and MTD/MAD as determined in phase 1a) Drug: AbGn-7 weekly iv infusion combined with FOLFOX7 Duration: 6 weeks
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| Related Clinical Trial | |||||
| NCT Number | NCT01466569 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 A/B Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AbGn-7 Therapy Alone and in Combination With the FOLFOX7 Treatment Regimen in Patients With Advanced Solid Tumors | ||||
| Primary Endpoint |
Safety evaluation includes adverse events (AEs), clinical lab tests, and physical exams over 10 weeks, focusing on treatment-emergent AEs and their severity.
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| Other Endpoint |
Pharmacokinetic analysis at 3 dose levels (Phase 1a) and 2 dose levels (Phase 1b), with immunogenicity assessment (anti-drug antibodies) and tumor response per RECIST criteria, monitored over 10-12 weeks
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References
