Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0HEJWD)
| ADC Name |
ABBV-011
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| Synonyms |
ABBV-011; SC-011
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| Organization |
Stemcentrx (Top20 MNC) (Originator)
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
2
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| Structure |
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| Antibody Name |
SC17
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Antibody Info | ||||
| Antigen Name |
Seizure protein 6 homolog (SEZ6)
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Antigen Info | ||||
| Payload Name |
N-acetyl-gamma-calicheamicin
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Payload Info | ||||
| Payload Target |
Human deoxyribonucleic acid (hDNA)
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Target Info | ||||
| Linker Name |
Mc-PEG8-acid-labile linker
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Linker Info | ||||
| Conjugate Type |
Reactive Cysteines
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| Special Approval(s) |
Orphan drug (EMA)
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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Discovered Using Patient-derived Xenograft Model
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) |
25%
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| Patients Enrolled |
Eligible participants have relapsed/refractory SCLC (1-3 prior lines), measurable disease (RECIST v1.1), ECOG 0-1, and adequate organ function. Key exclusions: cirrhosis, cardiac disease (>6 months prior), active infections, autoimmune/neurologic conditions, or hypersensitivity to study drugs. SEZ6+ tumor tissue is required for Parts B/C. Additional exclusions for Part C include neuropathy ≥G2, IBD, or prior anti-PD-1/PD-L1 with unresolved irAEs.
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| Administration Dosage |
ABBV-011 was administered intravenously at doses from 0.3 to 2.0 mg/kg once every 3 weeks. Dose expansion was conducted in SEZ6-selected patients.
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| Related Clinical Trial | |||||
| NCT Number | NCT03639194 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Study of ABBV-011 as a Single-Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Relapsed or Refractory Small Cell Lung Cancer | ||||
| Primary Endpoint |
The study evaluates AEs, SAEs, DLTs, and determines MTD/RP2D for ABBV-011 alone and in combination with budigalimab over ~5 years, alongside monitoring vital signs, lab abnormalities, and ECG changes.
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| Other Endpoint |
PK parameters (Cmax, AUC, Tmax, T1/2, etc.) and immunogenicity (ADA) for ABBV-011 are assessed. Efficacy endpoints include ORR, CBR, DOR, DOCB, PFS, and OS per RECIST v1.1 over ~5 years.
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| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Clinical benefit rate (CBR) |
64%
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| Patients Enrolled |
Eligible participants have relapsed/refractory SCLC (1-3 prior lines), measurable disease (RECIST v1.1), ECOG 0-1, and adequate organ function. Key exclusions: cirrhosis, cardiac disease (>6 months prior), active infections, autoimmune/neurologic conditions, or hypersensitivity to study drugs. SEZ6+ tumor tissue is required for Parts B/C. Additional exclusions for Part C include neuropathy ≥G2, IBD, or prior anti-PD-1/PD-L1 with unresolved irAEs.
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| Administration Dosage |
ABBV-011 was administered intravenously at doses from 0.3 to 2.0 mg/kg once every 3 weeks. Dose expansion was conducted in SEZ6-selected patients.
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| Related Clinical Trial | |||||
| NCT Number | NCT03639194 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Study of ABBV-011 as a Single-Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Relapsed or Refractory Small Cell Lung Cancer | ||||
| Primary Endpoint |
The study evaluates AEs, SAEs, DLTs, and determines MTD/RP2D for ABBV-011 alone and in combination with budigalimab over ~5 years, alongside monitoring vital signs, lab abnormalities, and ECG changes.
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| Other Endpoint |
PK parameters (Cmax, AUC, Tmax, T1/2, etc.) and immunogenicity (ADA) for ABBV-011 are assessed. Efficacy endpoints include ORR, CBR, DOR, DOCB, PFS, and OS per RECIST v1.1 over ~5 years.
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| Experiment 3 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT03639194 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1 study of ABBV-011 as a single-agent and in combination with budigalimab (ABBV-181) in subjects with relapsed or refractory small cell lung cancer. | ||||
Discovered Using Patient-derived Xenograft Model
| Experiment 1 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 15.30% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 LD(NAC-LD19.10)=0.24 mg/kg.
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| In Vivo Model | SCLC PDX model (PDX: LU64) | ||||
| Experiment 2 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 35.60% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 induces efficient tumor cell killing in cell line-derived models of LU64 and LU149 cells with SC17 expression with high expression.
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| In Vivo Model | Small cell lung cancer PDX model (PDX: LU149) | ||||
| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 42.85% | Negative SEZ6 expression (SEZ6-) | ||
| Method Description |
ABBV-011 induces efficient tumor cell killing in cell line-derived models of LU64 and LU149 cells with SC17 expression with high expression.
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| In Vivo Model | Small cell lung cancer PDX model (PDX: LU505) | ||||
| Experiment 4 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 45.90% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 ADC=8mg/kg.
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| In Vivo Model | SCLC PDX model (PDX: LU505) | ||||
| Experiment 5 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 71.70% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 ADC=1 mg/kg.
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| In Vivo Model | SCLC PDX model (PDX: LU149) | ||||
| Experiment 6 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 87% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
NAC-LD19.10 ADC=8mg/kg.
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| In Vivo Model | SCLC PDX model (PDX: LU505) | ||||
| Experiment 7 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 89.80% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 ADC=1 mg/kg.
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| In Vivo Model | SCLC PDX model (PDX: LU95) | ||||
| Experiment 8 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 89.80% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 induces efficient tumor cell killing in cell line-derived models of LU64 and LU149 cells with SC17 expression with high expression.
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| In Vivo Model | Small cell lung cancer PDX model (PDX: LU149) | ||||
| Experiment 9 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 92% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 ADC=0.5 mg/kg.
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| In Vivo Model | SCLC PDX model (PDX: LU64) | ||||
| Experiment 10 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 93.50% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 ADC=2 mg/kg.
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| In Vivo Model | SCLC PDX model (PDX: LU149) | ||||
| Experiment 11 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 94.78% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 induces efficient tumor cell killing in cell line-derived models of LU64 and LU149 cells with SC17 expression with high expression.
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| In Vivo Model | Small cell lung cancer PDX model (PDX: LU95) | ||||
| Experiment 12 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 96% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 induces efficient tumor cell killing in cell line-derived models of LU64 and LU149 cells with SC17 expression with high expression.
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| In Vivo Model | Small cell lung cancer PDX model (PDX: LU64) | ||||
| Experiment 13 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 96.80% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 ADC=2 mg/kg.
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| In Vivo Model | SCLC PDX model (PDX: LU95) | ||||
| Experiment 14 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 97% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 ADC=4 mg/kg.
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| In Vivo Model | SCLC PDX model (PDX: LU95) | ||||
| Experiment 15 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 98% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 ADC=1 mg/kg.
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| In Vivo Model | SCLC PDX model (PDX: LU64) | ||||
| Experiment 16 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 98.40% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 ADC=2 mg/kg.
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| In Vivo Model | SCLC PDX model (PDX: LU64) | ||||
| Experiment 17 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 98.70% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 ADC=4 mg/kg.
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| In Vivo Model | SCLC PDX model (PDX: LU149) | ||||
| Experiment 18 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 99.60% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 induces efficient tumor cell killing in cell line-derived models of LU64 and LU149 cells with SC17 expression with high expression.
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| In Vivo Model | Small cell lung cancer PDX model (PDX: LU95) | ||||
| Experiment 19 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 99.80% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 induces efficient tumor cell killing in cell line-derived models of LU64 and LU149 cells with SC17 expression with high expression.
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| In Vivo Model | Small cell lung cancer PDX model (PDX: LU95) | ||||
| Experiment 20 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 100% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 induces efficient tumor cell killing in cell line-derived models of LU64 and LU149 cells with SC17 expression with high expression.
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| In Vivo Model | Small cell lung cancer PDX model (PDX: LU149) | ||||
| Experiment 21 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 100% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 induces efficient tumor cell killing in cell line-derived models of LU64 and LU149 cells with SC17 expression with high expression.
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| In Vivo Model | Small cell lung cancer PDX model (PDX: LU64) | ||||
| Experiment 22 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 100% | Positive SEZ6 expression (SEZ6+++/++) | ||
| Method Description |
ABBV-011 induces efficient tumor cell killing in cell line-derived models of LU64 and LU149 cells with SC17 expression with high expression.
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| In Vivo Model | Small cell lung cancer PDX model (PDX: LU64) | ||||
References