Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (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
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
Sarcoma
1 Trials
Clinical trial identifier
NCT02565758; EudraCT2015-001645-84
Breast cancer
1 Trials
Clinical trial identifier
NCT02565758; EudraCT2015-001645-84
Head and neck cancer
1 Trials
Clinical trial identifier
NCT02565758; EudraCT2015-001645-84
Unspecific solid tumor
1 Trials
Clinical trial identifier
NCT02565758; EudraCT2015-001645-84
2027 Update
General Information of The ADMET Data Related to This ADC
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.

   Click to Show/Hide
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.