Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ID: DRG0IQKOR)
ADC Name
Aurixim
Synonyms
Aurixim; CON-4619; Rituximab conjugate (BioIntegrator LLC)
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Organization
BioIntegrator LLC
Drug Status
Phase 1
Antibody Name
Rituximab
  Antibody Info 
Antigen Name
B-lymphocyte antigen CD20 (MS4A1)
  Antigen Info 
Payload Name
Undisclosed
Linker Name
Undisclosed
2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
Disease Name Phase 1 Phase 2 Phase 3 Approved
Lymphoma
1 Trials
Clinical trial identifier
NCT03057418
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
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Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT03057418
PHASE1
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

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Undisclosed  NCT03057418
Phase 1
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.

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Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
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.
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.
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.
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
Ref 1 Open-label Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Aurixim
Ref 2 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, NCT03057418