Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0IQKOR
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| ADC Name |
Aurixim
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| Synonyms |
Aurixim; CON-4619; Rituximab conjugate (BioIntegrator LLC)
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| Organization |
BioIntegrator LLC
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| Drug Status |
Phase 1
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| Antibody Name |
Rituximab
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Antibody Info | ||||
| Antigen Name |
B-lymphocyte antigen CD20 (MS4A1)
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Antigen Info | ||||
| Payload Name |
Undisclosed
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| Therapeutic Target |
Stimulator of interferon genes protein (STING1)
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Target Info | ||||
| Linker Name |
Undisclosed
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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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| Lymphoma |
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: Adults (≥18y) with CD20+ indolent B-cell NHL (follicular, MALT, or marginal zone lymphoma), measurable lesions (>1.5cm), ECOG 0-2, adequate organ function, and contraception use. Exclusion: Prior MAb therapy (3 months), active infections, CNS involvement, severe cardiovascular/neuropathic conditions, HIV/HBV/HCV positivity, pregnancy, or uncontrolled comorbidities per investigator judgment.
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| Administration Dosage |
Dosage: 125 mg/m2, 250 mg/m2, 375 mg/m2 and 500 mg/m2. Formulation: concentrate for preparation of infusions 500 mg/50 ml and 100 mg/10 ml.Mode of administration: intravenous.
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| Related Clinical Trial | |||||
| NCT Number | NCT03057418 | Clinical Status | PHASE1 | ||
| Clinical Description | Open-label Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Aurixim Multiple Doses in Patients With Recurrent/Refractory B-cell, CD20-positive Non-Hodgkin Lymphoma of Low Tumor Grade or With Follicular Lymphoma | ||||
| Primary Endpoint |
The study evaluates treatment-emergent adverse events (AEs) and determines the maximum tolerated dose (MTD) of Aurixim over 24 weeks. Safety assessments include CTCAE-graded AEs, lab abnormalities, and ECG findings. MTD is defined as the highest dose where ≤1/6 patients experience dose-limiting toxicities (DLTs) within 36 days.
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| Other Endpoint |
Pharmacokinetic (AUC, Cmax, T1/2) and pharmacodynamic (CD19+ levels) analyses will be conducted up to week 71 after single/multiple Aurixim doses to characterize drug exposure and biological effects.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT03057418 | Clinical Status | Phase 1 | ||
| Clinical Description | Open-label study of safety, tolerability, pharmacokinetics and pharmacodynamics of auriim multiple doses in patients with recurrent/refractory -cell, CD20-positive non-hodgkin lymphoma of low tumor grade or with follicular lymphoma. | ||||
References