Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0AWUIJ
ADC Name
Indatuximab ravtansine
Synonyms
BT-062; nBT-062; Anti-myeloma monoclonal antibody-DM4 immunoconjugate BT-062; Maytansinoid-conjugated anti-myeloma monoclonal antibody BT-062
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Organization
Biotest Pharma GmbH; Biotest AG
Drug Status
Phase 2
Indication
In total 3 Indication(s)
Bladder cancer [ICD11:2C94]
Phase 2
Breast cancer [ICD11:2C60-2C65]
Terminated in phase 2
Multiple myeloma [ICD11:2A83]
Terminated in phase 2
Drug-to-Antibody Ratio
3-4
Structure
Antibody Name
Indatuximab
  Antibody Info 
Antigen Name
Syndecan-1 (SDC1)
  Antigen Info 
Payload Name
Mertansine DM4
  Payload Info 
Therapeutic Target
Microtubule (MT)
  Target Info 
Linker Name
N-succinimidyl 4-(2-pyridyldithio) butanoate (SPDB)
  Linker Info 
Conjugate Type
Random conjugation through nucleophilic lysines.
Combination Type
Ravtansine
Puchem SID
472423471 , 223370377 , 160671957
Drugbank ID
DB16195
TTD ID
D00CQI
ChEBI ID
CHEMBL1743031
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Objective Response Rate (ORR)  NCT00723359
Phase 1
A phase 1 dose escalation study to evaluate maximum tolerated dose (MTD), pharmacokinetics (PK), and safety of BT062 in subjects with relapsed or relapsed/refractory multiple myeloma.
Undisclosed  NCT01638936
Phase 1
A phase 1/2a multi-dose escalation study of BT062 in combination with lenalidomide or pomalidomide and dexamethasone in subjects with relapsed or relapsed/refractory multiple myeloma.
Discovered Using Patient-derived Xenograft Model
Click To Hide/Show 10 Activity Data Related to This Level
Standard Type Value Units Animal Model (No. of PDX)
Tumor Growth Inhibition value (TGI) 
≈ 0
%
Triple-negative breast cancer PDX model (PDX: MAXF1384)
Tumor Growth Inhibition value (TGI) 
≈ 0
%
Triple-negative breast cancer PDX model (PDX: MAXF1384)
Tumor Growth Inhibition value (TGI) 
≈ 0
%
Triple-negative breast cancer PDX model (PDX: MAXF1384)
Tumor Growth Inhibition value (TGI) 
≈ 25
%
Triple-negative breast cancer PDX model (PDX: MAXF401)
Tumor Growth Inhibition value (TGI) 
≈ 55
%
Triple-negative breast cancer PDX model (PDX: MAXF401)
Tumor Growth Inhibition value (TGI) 
≈ 55
%
Triple-negative breast cancer PDX model (PDX: MAXF1384)
Tumor Growth Inhibition value (TGI) 
≈ 70
%
Triple-negative breast cancer PDX model (PDX: MAXF1384)
Tumor Growth Inhibition value (TGI) 
≈ 95.5
%
Triple-negative breast cancer PDX model (PDX: MAXF401)
Tumor Growth Inhibition value (TGI) 
≈ 99.8
%
Triple-negative breast cancer PDX model (PDX: MAXF401)
Tumor Growth Inhibition value (TGI) 
≈ 100
%
Triple-negative breast cancer PDX model (PDX: MAXF401)
Discovered Using Cell Line-derived Xenograft Model
Click To Hide/Show 10 Activity Data Related to This Level
Standard Type Value Units Cell Line Disease Model
Tumor Growth Inhibition value (TGI) 
≈ 38.86
%
Multiple myeloma cells
Multiple myeloma
Tumor Growth Inhibition value (TGI) 
≈ 40.42
%
MMXF L363 cells
Plasma cell myeloma
Tumor Growth Inhibition value (TGI) 
≈ 50
%
Multiple myeloma cells
Multiple myeloma
Tumor Growth Inhibition value (TGI) 
≈ 55.69
%
Multiple myeloma cells
Multiple myeloma
Tumor Growth Inhibition value (TGI) 
≈ 59.9
%
Multiple myeloma cells
Multiple myeloma
Tumor Growth Inhibition value (TGI) 
≈ 65.34
%
Multiple myeloma cells
Multiple myeloma
Tumor Growth Inhibition value (TGI) 
≈ 77.26
%
MMXF L363 cells
Plasma cell myeloma
Tumor Growth Inhibition value (TGI) 
≈ 77.27
%
JIMT-1 cells
Breast ductal carcinoma
Tumor Growth Inhibition value (TGI) 
≈ 79.2
%
Multiple myeloma cells
Multiple myeloma
Tumor Growth Inhibition value (TGI) 
≈ 92.05
%
JIMT-1 cells
Breast ductal carcinoma
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]
Efficacy Data Objective Response Rate (ORR)
3.20% (on the single-dose regimen)
5.90% (the multi-dose regimen)
Patients Enrolled
Relapsed and/or refractory multiple myeloma (MM) previously treated with an immunomodulatory drug and a proteasome inhibitor.
Administration Dosage
In the first-in-human study, indatuximab ravtansine (10, 20, 40, 80, 120, 160, 200 mg/m2) was administered to 32 patients on day 1 of each 21-day cycle. The MTD was 160 mg/m2. In the phase I/IIa study, indatuximab ravtansine (40, 50, 65, 80, 100, 120, 140, 160 mg/m2) was administered to 35 patients on days 1, 8, and 15 of each 28-day cycle, and the MTD/recommended phase II dose was 140 mg/m2.

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Related Clinical Trial
NCT Number NCT00723359  Clinical Status Phase 1
Clinical Description A phase 1 dose escalation study to evaluate maximum tolerated dose (MTD), pharmacokinetics (PK), and safety of BT062 in subjects with relapsed or relapsed/refractory multiple myeloma.
Primary Endpoint
The 160 mg/m2 dose was therefore defined as MTD for the Single-dose Regimen.
Other Endpoint
Most (88.00%) adverse events were grade 1 or 2, the most common being diarrhea and fatigue. There was rapid clearance of indatuximab ravtansine and no relevant accumulation.
Experiment 2 Reporting the Activity Date of This ADC [2]
Patients Enrolled
Relapsed or refractory multiple myeloma, and ECOG performance status or Zubrod score of 2 or below.
Administration Dosage
Intravenously on days 1, 8, and 15 of each 28-day cycle in escalating dose levels of 80 mg/m2, 100 mg/m2, and 120 mg/m2, with lenalidomide (25 mg; days 1 to 21 every 28 days orally) and dexamethasone (20-40 mg; days 1, 8, 15, and 22 every 28 days) (phase 1).
Related Clinical Trial
NCT Number NCT01638936  Clinical Status Phase 1
Clinical Description A phase 1/2a multi-dose escalation study of BT062 in combination with lenalidomide or pomalidomide and dexamethasone in subjects with relapsed or relapsed/refractory multiple myeloma.
Discovered Using Patient-derived Xenograft Model
Click To Hide/Show 10 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [3]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 0.00% (Day 39) Moderate CD138 expression (CD138++)
Method Description
The inhibitory activity of indatuximab ravtansine against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 1 mg/kg.
In Vivo Model Triple-negative breast cancer PDX model (PDX: MAXF1384)
Experiment 2 Reporting the Activity Date of This ADC [3]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 0.00% Moderate CD138 expression (CD138++)
Method Description
The inhibitory activity of indatuximab ravtansine against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 2 mg/kg.
In Vivo Model Triple-negative breast cancer PDX model (PDX: MAXF1384)
Experiment 3 Reporting the Activity Date of This ADC [3]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 0.00% (Day 39) Moderate CD138 expression (CD138++)
Method Description
The inhibitory activity of indatuximab ravtansine against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 4 mg/kg.
In Vivo Model Triple-negative breast cancer PDX model (PDX: MAXF1384)
Experiment 4 Reporting the Activity Date of This ADC [3]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 25.00% (Day 38) High CD138 expression (CD138+++)
Method Description
The inhibitory activity of indatuximab ravtansine against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 1 mg/kg.
In Vivo Model Triple-negative breast cancer PDX model (PDX: MAXF401)
Experiment 5 Reporting the Activity Date of This ADC [3]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 55.00% (Day 38) High CD138 expression (CD138+++)
Method Description
The inhibitory activity of indatuximab ravtansine against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 2 mg/kg.
In Vivo Model Triple-negative breast cancer PDX model (PDX: MAXF401)
Experiment 6 Reporting the Activity Date of This ADC [3]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 55.00% (Day 39) Moderate CD138 expression (CD138++)
Method Description
The inhibitory activity of indatuximab ravtansine combination docetaxel against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated docetaxel with 10 mg/kg and treated indatuximab ravtansine with 2 mg/kg.
In Vivo Model Triple-negative breast cancer PDX model (PDX: MAXF1384)
Experiment 7 Reporting the Activity Date of This ADC [3]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 70.00% (Day 39) Moderate CD138 expression (CD138++)
Method Description
The inhibitory activity of indatuximab ravtansine against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 8mg/kg.
In Vivo Model Triple-negative breast cancer PDX model (PDX: MAXF1384)
Experiment 8 Reporting the Activity Date of This ADC [3]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 95.50% (Day 38) High CD138 expression (CD138+++)
Method Description
The inhibitory activity of indatuximab ravtansine against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 4 mg/kg.
In Vivo Model Triple-negative breast cancer PDX model (PDX: MAXF401)
Experiment 9 Reporting the Activity Date of This ADC [3]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 99.80% (Day 38) High CD138 expression (CD138+++)
Method Description
The inhibitory activity of indatuximab ravtansine against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 8mg/kg.
In Vivo Model Triple-negative breast cancer PDX model (PDX: MAXF401)
Experiment 10 Reporting the Activity Date of This ADC [3]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 100.00% (Day 38) High CD138 expression (CD138+++)
Method Description
The inhibitory activity of indatuximab ravtansine combination docetaxel against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated docetaxel with 10 mg/kg and treated indatuximab ravtansine with 2 mg/kg.
In Vivo Model Triple-negative breast cancer PDX model (PDX: MAXF401)
Discovered Using Cell Line-derived Xenograft Model
Click To Hide/Show 10 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 38.86% (Day 14) Moderate CD138 expression (CD138++)
Method Description
The inhibitory activity of indatuximab ravtansine combination lenalidomide against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 5.3 mg/kg body weight for 14 days.
In Vivo Model Multiple myeloma CDX model
In Vitro Model Multiple myeloma Multiple myeloma cells Homo sapiens
Experiment 2 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 40.42% (Day 17) High CD138 expression (CD138+++)
Method Description
The inhibitory activity of indatuximab ravtansine against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 2 mg/kg/day.
In Vitro Model Plasma cell myeloma MMXF L363 cells Homo sapiens
Experiment 3 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 50.00% (Day 14) Moderate CD138 expression (CD138++)
Method Description
The inhibitory activity of indatuximab ravtansine against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 5.3 mg/kg body weight for 14 days.
In Vivo Model Multiple myeloma CDX model
In Vitro Model Multiple myeloma Multiple myeloma cells Homo sapiens
Experiment 4 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 55.69% (Day 14) Moderate CD138 expression (CD138++)
Method Description
The inhibitory activity of indatuximab ravtansine combination lenalidomide against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 10.6 mg/kg body weight for 14 days.
In Vivo Model Multiple myeloma CDX model
In Vitro Model Multiple myeloma Multiple myeloma cells Homo sapiens
Experiment 5 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 59.90% (Day 14) Moderate CD138 expression (CD138++)
Method Description
The inhibitory activity of indatuximab ravtansine against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 10.6 mg/kg body weight for 14 days.
In Vivo Model Multiple myeloma CDX model
In Vitro Model Multiple myeloma Multiple myeloma cells Homo sapiens
Experiment 6 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 65.34% (Day 14) Moderate CD138 expression (CD138++)
Method Description
The inhibitory activity of indatuximab ravtansine against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 21.2 mg/kg body weight for 14 days.
In Vivo Model Multiple myeloma CDX model
In Vitro Model Multiple myeloma Multiple myeloma cells Homo sapiens
Experiment 7 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 77.26% (Day 17) High CD138 expression (CD138+++)
Method Description
The inhibitory activity of indatuximab ravtansine against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 4 mg/kg/day.
In Vitro Model Plasma cell myeloma MMXF L363 cells Homo sapiens
Experiment 8 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 77.27% (Day 17) High CD138 expression (CD138+++)
Method Description
The inhibitory activity of indatuximab ravtansine+lenalidomide (Len; 20 mg/kg/day) and dexamethasone (1.25 mg/kg/day) against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated IR with 2 mg/kg/day.
In Vitro Model Breast ductal carcinoma JIMT-1 cells CVCL_2077
Experiment 9 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 79.20% (Day 14) Moderate CD138 expression (CD138++)
Method Description
The inhibitory activity of indatuximab ravtansine combination lenalidomide against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated with 21.2 mg/kg body weight for 14 days.
In Vivo Model Multiple myeloma CDX model
In Vitro Model Multiple myeloma Multiple myeloma cells Homo sapiens
Experiment 10 Reporting the Activity Date of This ADC [4]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 92.05% (Day 17) High CD138 expression (CD138+++)
Method Description
The inhibitory activity of indatuximab ravtansine+lenalidomide (Len; 20 mg/kg/day) and dexamethasone (1.25 mg/kg/day) against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated IR with 4 mg/kg/day.
In Vitro Model Breast ductal carcinoma JIMT-1 cells CVCL_2077
References
Ref 1 Indatuximab Ravtansine (BT062) Monotherapy in Patients With Relapsed and/or Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2019 Jun;19(6):372-380.
Ref 2 Indatuximab ravtansine plus dexamethasone with lenalidomide or pomalidomide in relapsed or refractory multiple myeloma: a multicentre, phase 1/2a study. Lancet Haematol. 2021 Nov;8(11):e794-e807.
Ref 3 Activity of Indatuximab Ravtansine against Triple-Negative Breast Cancer in Preclinical Tumor Models. Pharm Res. 2018 Apr 17;35(6):118.
Ref 4 Indatuximab ravtansine (BT062) combination treatment in multiple myeloma: pre-clinical studies. J Hematol Oncol. 2017 Jan 11;10(1):13.

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