Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0OMVBK
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| ADC Name |
Azintuxizumab vedotin
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| Synonyms |
azintuxizumab vedotin; ABBV-838
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| Organization |
AbbVie (Top20 MNC) (Originator)
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
Azintuxizumab
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Antibody Info | ||||
| Antigen Name |
SLAM family member 7 (SLAMF7)
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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 |
Mc-Val-Cit-PABC
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
vedotin
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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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| Multiple myeloma |
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] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
10.67%
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| Patients Enrolled |
Relapsed or refractory multiple myeloma (RRMM) and Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; were not eligible for stem cell/bone marrow transplant or had refused stem cell/bone marrow transplant, or had relapsed after autologous or allogeneic stem cell/bone marrow transplant.
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| Administration Dosage |
ABBV-838 (3+3 design) intravenously starting from 0.60 mg/kg up to 6.00 mg/kg for 3-week dosing intervals (Q3W). Patients could continue ABBV-838 for up to 24 months. Assessment of alternate dosing intervals (Q1W and Q2W) was conducted in parallel.
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| Related Clinical Trial | |||||
| NCT Number | NCT02462525 | Clinical Status | Phase 1 | ||
| Clinical Description | A multicenter, phase 1/1b, open-label, dose-escalation study of ABBV-838, an antibody drug conjugate, in subjects with relapsed and refractory multiple myeloma. | ||||
| Primary Endpoint |
OrR=10.67% (N=8/75, 95% Cl 4.7-19.9), very good partial response (VGPR)=2.67% (N=2), PR=8.00% (N=6). Median DOR=4 months.
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| Other Endpoint |
The MTD was not reached. The selected recommended dose for the expansion cohort was 5.00 mg/kg Q3W.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT02951117 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1b, open label, multicenter, dose escalation study of venetoclax and ABBV-838 combination therapy with dexamethasone in subjects with relapsed or refractory multiple myeloma. | ||||
| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT02462525 | Clinical Status | Phase 1 | ||
| Clinical Description | A multicenter, phase 1/1b, open-label, dose-escalation study of ABBV-838, an antibody drug conjugate, in subjects with relapsed and refractory multiple myeloma. | ||||
| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible participants had relapsed/refractory multiple myeloma (≥3 prior lines including proteasome inhibitors/immunomodulatory drugs) with measurable disease, adequate organ function, and LVEF ≥45% if applicable. Exclusions included recent anticancer therapy (<21 days), solid tumors, unresolved toxicities (≥Grade 2), uncontrolled conditions, active infections, strong CYP3A4 inhibitors, HIV/hepatitis, or prior pomalidomide exposure for combination-arm participants.
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| Administration Dosage |
Eligible patients (≥18 years) received ABBV-838 (3+3 design) intravenously starting from 0.6 mg/kg up to 6.0 mg/kg for 3-week dosing intervals (Q3W). Patients could continue ABBV-838 for up to 24 months. Assessment of alternate dosing intervals (Q1W and Q2W) was conducted in parallel.
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| Related Clinical Trial | |||||
| NCT Number | NCT02462525 | Clinical Status | PHASE1 | ||
| Clinical Description | A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma | ||||
| Primary Endpoint |
Pharmacokinetic evaluation of ABBV-838 included maximum plasma concentration (Cmax, ng/ml) measured at multiple timepoints (Cycles 1-3) and maximum tolerated dose assessment (over ~2 years), with dose-limiting toxicities monitored to determine safety thresholds.
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| Other Endpoint |
Preliminary efficacy of ABBV-838 monotherapy was based on International Myeloma Working Group (IMWG) response criteria, assessed radiologically at screening, Cycle 1 Day 15, and periodically thereafter (~3 years).
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| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| Patients Enrolled |
Eligible participants had relapsed/refractory multiple myeloma (≥2 prior therapies including IMiD + proteasome inhibitor), measurable disease (serum/urine M-protein or sFLC), and ECOG ≤1 (dose escalation) or ≤2 (expansion). Exclusions included recent anti-myeloma therapy (within 5 half-lives/14 days for non-mAbs; 6 weeks for mAbs), uncontrolled comorbidities, or corticosteroid use (≥4 mg/day dexamethasone within 3 weeks).
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT02951117 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1b, Open Label, Multicenter, Dose Escalation Study of Venetoclax and ABBV-838 Combination Therapy With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma | ||||
| Primary Endpoint |
The study aims to determine the maximum tolerated dose (MTD) and recommended phase two dose (RPTD) of venetoclax + ABBV-838 + dexamethasone during dose escalation (1 cycle, 21-28 days). Safety will be monitored via adverse events (AEs) for ~2 years post-enrollment.
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| Other Endpoint |
Pharmacokinetic parameters (Cmax, Tmax, AUC) of venetoclax and ABBV-838 will be assessed over ~43-57 days, alongside efficacy (ORR per IMWG criteria), toxin levels (MMAE), total mAb, and MRD negativity (10^-5 threshold by NGS). Terminal elimination (t1/2, beta) of ABBV-838 will be analyzed on Cycle 1 Day 1.
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References