Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ID: DRG0OMVBK)
ADC Name
Azintuxizumab vedotin
Synonyms
azintuxizumab vedotin; ABBV-838
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Organization
AbbVie (Top20 MNC) (Originator)
Drug Status
Phase 1 (discontinued)
Drug-to-Antibody Ratio
4
Structure
Antibody Name
Azintuxizumab
  Antibody Info 
Antigen Name
SLAM family member 7 (SLAMF7)
  Antigen Info 
Payload Name
Monomethyl auristatin E
  Payload Info 
Payload Target
Microtubule (MT)
  Target Info 
Linker Name
Mc-Val-Cit-PABC
  Linker Info 
Conjugate Type
Random Cysteines
Combination Type
vedotin
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
Multiple myeloma
1 Trials
Clinical trial identifier
NCT02462525; EudraCT2014-002609-39
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 5 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT02462525
PHASE1
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
Undisclosed  NCT02951117
PHASE1
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
Objective Response Rate (ORR)  NCT02462525
Phase 1
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.
Undisclosed  NCT02951117
Phase 1
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.
Undisclosed  NCT02462525
Phase 1
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.
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 5 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Eligible participants had relapsed/refractory multiple myeloma (&ge;3 prior lines including proteasome inhibitors/immunomodulatory drugs) with measurable disease, adequate organ function, and LVEF &ge;45% if applicable. Exclusions included recent anticancer therapy (<21 days), solid tumors, unresolved toxicities (&ge;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.
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.
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).
Experiment 2 Reporting the Activity Date of This ADC [2]
Patients Enrolled
Eligible participants had relapsed/refractory multiple myeloma (&ge;2 prior therapies including IMiD + proteasome inhibitor), measurable disease (serum/urine M-protein or sFLC), and ECOG &le;1 (dose escalation) or &le;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 (&ge;4 mg/day dexamethasone within 3 weeks).

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Administration Dosage
.
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.
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.
Experiment 3 Reporting the Activity Date of This ADC [3]
Efficacy Data Objective Response Rate (ORR)
10.67%
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.
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.
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.
Other Endpoint
The MTD was not reached. The selected recommended dose for the expansion cohort was 5.00 mg/kg Q3W.
Experiment 4 Reporting the Activity Date of This ADC [4]
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 5 Reporting the Activity Date of This ADC [5]
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.
References
Ref 1 Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma
Ref 2 A Study of Venetoclax and ABBV-838 Combination Therapy With Dexamethasone in Participants With Multiple Myeloma Whose Cancer Has Come Back or Had No Response to Recent Cancer Treatment
Ref 3 First-in-Human Phase I Study of ABBV-838, an Antibody-Drug Conjugate Targeting SLAMF7/CS1 in Patients with Relapsed and Refractory Multiple Myeloma. Clin Cancer Res. 2020 May 15;26(10):2308-2317.
Ref 4 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, NCT02951117
Ref 5 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, NCT02462525