Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0OPFVY
ADC Name
Samrotamab vedotin
Synonyms
samrotamab vedotin; ABBV-085; PR-1498487 PAB-MMAE
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Organization
AbbVie (Top20 MNC) (Originator)
Drug Status
Phase 1 (discontinued)
Drug-to-Antibody Ratio
2
Structure
Antibody Name
Samrotamab
  Antibody Info 
Antigen Name
Leucine-rich repeat-containing protein 15 (LRRC15)
  Antigen Info 
Payload Name
MMAE
  Payload Info 
Therapeutic Target
Microtubule (MT)
  Target Info 
Linker Name
Mc-Val-Cit-PABC
  Linker Info 
Conjugate Type
Random Cysteines
Combination Type
vedotin
Elimination
Polatuzumab vedotin is predominantly excreted in feces, as well as in urine to some extent. The predicted clearance of polatuzumab vedotin is 0.9 L/day.
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
Breast cancer
1 Trials
Trial ID
NCT02565758; EudraCT2015-001645-84
Head and neck cancer
1 Trials
Trial ID
NCT02565758; EudraCT2015-001645-84
Sarcomas
1 Trials
Trial ID
NCT02565758; EudraCT2015-001645-84
Unspecific solid tumor
1 Trials
Trial ID
NCT02565758; EudraCT2015-001645-84
General Information of The ADMET Data Related to This ADC(2027 Update)
Absorption
Click To Hide/Show 1 Absorption Data Related to This Level
Standard Type Value Units Description Reference
Maximum Observed Concentration (Cmax) 62 ug/mL
The concentration-time profiles after the first dose in cycle 1 are reported for patients dosed at 3.6 mg/kg every 2 weeks
 [1]
Excretion
Click To Hide/Show 1 Excretion Data Related to This Level
Standard Type Value Units Description Reference
Elimination Half-Life (t1/2) 3 day
The concentration-time profiles after the first dose in cycle 1 are reported for patients dosed at 3.6 mg/kg every 2 weeks
 [1]
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT02565758
PHASE1
A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
Objective Response Rate (ORR)  NCT02565758
Phase 1
A multicenter, phase 1, open-label, dose-escalation study of ABBV-085, an antibody drug conjugate, in subjects with advanced solid tumors.
Undisclosed  NCT02565758
Phase 1
A multicenter, phase 1, open-label, dose-escalation study of ABBV-085, an antibody drug conjugate, in subjects with advanced solid tumors.
Discovered Using Patient-derived Xenograft Model
Click To Hide/Show 7 Activity Data Related to This Level
Standard Type Value Units Animal Model (No. of PDX)
Tumor Growth Inhibition value (TGI) 
≈ 27.9
%
Liposarcoma PDX model (PDX: LPS28)
Tumor Growth Inhibition value (TGI) 
≈ 34.5
%
Leiomyosarcoma PDX model (PDX: LMS33)
Tumor Growth Inhibition value (TGI) 
≈ 38.1
%
Liposarcoma PDX model (PDX: LPS28)
Tumor Growth Inhibition value (TGI) 
≈ 87.2
%
Liposarcoma PDX model (PDX: LPS28)
Tumor Growth Inhibition value (TGI) 
≈ 88.7
%
Leiomyosarcoma PDX model (PDX: LMS33)
Tumor Growth Inhibition value (TGI) 
≈ 95.2
%
Leiomyosarcoma and undifferentiated sarcomas PDX model, (PDX: UPS7)
Tumor Growth Inhibition value (TGI) 
≈ 100
%
Leiomyosarcoma and undifferentiated sarcomas PDX model, (PDX: UPS7)
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [2]
Patients Enrolled
Eligible participants have advanced solid tumors (ECOG 0-2, measurable/evaluable disease per RECIST 1.1 or tumor antigen criteria) and adequate organ function. Exclusions include recent anticancer therapy, uncontrolled CNS metastases, unresolved Grade 2+ toxicities, hemolysis, major surgery within 28 days, or auristatin/IgG hypersensitivity.
Administration Dosage
ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson
Related Clinical Trial
NCT Number NCT02565758  Clinical Status PHASE1
Clinical Description A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
Primary Endpoint
The study evaluates ABBV-085's terminal elimination half-life, Cmax, AUC (0-t), and adverse events over 24 months, with continuous monitoring of safety and pharmacokinetics.
Other Endpoint
Key efficacy endpoints include ORR (CR+PR rate), PFS (time to progression/death), and DOR (response duration), all assessed over a 24-month period to determine treatment impact.
Experiment 2 Reporting the Activity Date of This ADC [3]
Efficacy Data Objective Response Rate (ORR)
2.10
10.80
20.00
20.00
20.00 %
Patients Enrolled
Patients with LRRC15 positive squamous cell carcinoma of the head and neck, NSCKC, breast cancer, undifferentiated pleomorphic sarcoma or osteosarcoma.
Administration Dosage
0.30 up to 6.00 mg/kg on day 1, once every 2 weeks.
Related Clinical Trial
NCT Number NCT02565758  Clinical Status Phase 1
Clinical Description A multicenter, phase 1, open-label, dose-escalation study of ABBV-085, an antibody drug conjugate, in subjects with advanced solid tumors.
Experiment 3 Reporting the Activity Date of This ADC [4]
Related Clinical Trial
NCT Number NCT02565758  Clinical Status Phase 1
Clinical Description A multicenter, phase 1, open-label, dose-escalation study of ABBV-085, an antibody drug conjugate, in subjects with advanced solid tumors.
Discovered Using Patient-derived Xenograft Model
Click To Hide/Show 7 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [5]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 27.90% Negative LRRC15 (LRRC15-)
Method Description
The efficacy of ABBV-085 directed against LRRC15 was assessed in several patient-derived xenograft models of UPS,LMS,and DDLPS. For efficacy study,tumors were allowed to establish to 200±50 mm3 in size before randomization into various treatment groups with 7-9 mice per group. Isotype-control,isotype-MMAE,and ABBV-085,diluted in PBS were administered at 6 mg/kg once every 4 days intraperitoneally for a total of six injections.

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In Vivo Model Liposarcoma PDX model (PDX: LPS28)
Experiment 2 Reporting the Activity Date of This ADC [5]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 34.50% Negative LRRC15 (LRRC15-)
Method Description
The efficacy of ABBV-085 directed against LRRC15 was assessed in several patient-derived xenograft models of UPS,LMS,and DDLPS. For efficacy study,tumors were allowed to establish to 200±50 mm3 in size before randomization into various treatment groups with 7-9 mice per group. Isotype-control,isotype-MMAE,and ABBV-085,diluted in PBS were administered at 6 mg/kg once every 4 days intraperitoneally for a total of six injections.

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In Vivo Model Leiomyosarcoma PDX model (PDX: LMS33)
Experiment 3 Reporting the Activity Date of This ADC [5]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 38.10% Negative LRRC15 (LRRC15-)
Method Description
The efficacy of ABBV-085 directed against LRRC15 was assessed in several patient-derived xenograft models of UPS,LMS,and DDLPS. For efficacy study,tumors were allowed to establish to 200±50 mm3 in size before randomization into various treatment groups with 7-9 mice per group. Isotype-control,isotype-MMAE,and ABBV-085,diluted in PBS were administered at 6 mg/kg once every 4 days intraperitoneally for a total of six injections.

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In Vivo Model Liposarcoma PDX model (PDX: LPS28)
Experiment 4 Reporting the Activity Date of This ADC [5]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 87.20% High LRRC15 expression (LRRC15+++)
Method Description
The efficacy of ABBV-085 directed against LRRC15 was assessed in several patient-derived xenograft models of UPS,LMS,and DDLPS. For efficacy study,tumors were allowed to establish to 200±50 mm3 in size before randomization into various treatment groups with 7-9 mice per group. Isotype-control,isotype-MMAE,and ABBV-085,diluted in PBS were administered at 6 mg/kg once every 4 days intraperitoneally for a total of six injections.

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In Vivo Model Liposarcoma PDX model (PDX: LPS28)
Experiment 5 Reporting the Activity Date of This ADC [5]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 88.70% High LRRC15 expression (LRRC15+++)
Method Description
The efficacy of ABBV-085 directed against LRRC15 was assessed in several patient-derived xenograft models of UPS,LMS,and DDLPS. For efficacy study,tumors were allowed to establish to 200±50 mm3 in size before randomization into various treatment groups with 7-9 mice per group. Isotype-control,isotype-MMAE,and ABBV-085,diluted in PBS were administered at 6 mg/kg once every 4 days intraperitoneally for a total of six injections.

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In Vivo Model Leiomyosarcoma PDX model (PDX: LMS33)
Experiment 6 Reporting the Activity Date of This ADC [5]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 95.20% High LRRC15 expression (LRRC15+++)
Method Description
The efficacy of ABBV-085 directed against LRRC15 was assessed in several patient-derived xenograft models of UPS,LMS,and DDLPS. For efficacy study,tumors were allowed to establish to 200±50 mm3 in size before randomization into various treatment groups with 7-9 mice per group. Isotype-control,isotype-MMAE,and ABBV-085,diluted in PBS were administered at 6 mg/kg once every 4 days intraperitoneally for a total of six injections.

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In Vivo Model Leiomyosarcoma and undifferentiated sarcomas PDX model, (PDX: UPS7)
Experiment 7 Reporting the Activity Date of This ADC [5]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 100% High LRRC15 expression (LRRC15+++)
Method Description
The efficacy of ABBV-085 directed against LRRC15 was assessed in several patient-derived xenograft models of UPS,LMS,and DDLPS. For efficacy study,tumors were allowed to establish to 200±50 mm3 in size before randomization into various treatment groups with 7-9 mice per group. Isotype-control,isotype-MMAE,and ABBV-085,diluted in PBS were administered at 6 mg/kg once every 4 days intraperitoneally for a total of six injections.

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In Vivo Model Leiomyosarcoma and undifferentiated sarcomas PDX model, (PDX: UPS7)
References
Ref 1 First-in-Human Phase I Study of ABBV-085, an Antibody-Drug Conjugate Targeting LRRC15, in Sarcomas and Other Advanced Solid Tumors
Ref 2 ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
Ref 3 A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors, NCT02565758
Ref 4 First-in-human dose escalation and expansion study of SYSA1801, an antibody-drug conjugate targeting claudin 18.2 in patients with resistant/refractory solid tumors. J Clin Oncol. 2023 41:16_suppl, 3016-3016.
Ref 5 LRRC15 Targeting in Soft-Tissue Sarcomas: Biological and Clinical Implications. Cancers (Basel). 2020 Mar 23;12(3):757.