General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0XLSWN
ADC Name
SC-006
Synonyms
SC-006
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Organization
Stemcentrx (Top20 MNC) (Originator)
Drug Status
Phase 1 (discontinued)
Drug-to-Antibody Ratio
2
Structure
Antibody Name
Anti-RNF43 antibody
 Antibody Info 
Antigen Name
E3 ubiquitin-protein ligase RNF43 (RNF43)
 Antigen Info 
Payload Name
SG3312 (SC-DR003)
 Payload Info 
Therapeutic Target
Human deoxyribonucleic acid (hDNA)
 Target Info 
Linker Name
Mc-Val-Ala
 Linker Info 
Conjugate Type
Reactive Cysteines
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
Colorectal cancer
1 Trials
Trial ID
NCT03035279
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
stable disease (SD)  NCT03035279
PHASE1
An Open Label Phase 1 Study of SC-006 as a Single Agent and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer
progressive disease (PD)  NCT03035279
PHASE1
An Open Label Phase 1 Study of SC-006 as a Single Agent and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer
Objective Response Rate (ORR)  NCT03035279
Phase 1
An open label phase 1 study of SC-006 as a single agent and in combination with ABBV-181 in subjects with advanced colorectal cancer.
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 [1]
Efficacy Data stable disease (SD)
34%
Patients Enrolled
Eligible participants must have advanced metastatic CRC refractory to ≥2 prior systemic therapies, ECOG 0-1, and adequate organ function. Key exclusions include prior PBD/IND-based drug exposure, autoimmune/immunodeficiency disorders, IBD history, or recent immunosuppressant use within 14 days prior to treatment. Combination therapy excludes patients with immune-mediated pneumonitis or transplant history.

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Administration Dosage
As of April 2019, 29 patients were enrolled (n=20 in part A and n=9 in part B). All patients experienced at least one treatment-emergent adverse event (TEAE). Two patients (7%) had dose-limiting toxicities of grade 4 thrombocytopenia. All 29 patients discontinued from the study, with study drug being discontinued for 76% of patients due to progressive disease. One death occurred in part A due to gastrointestinal hemorrhage with possible relation to SC-006. Serious TEAEs occurred in 8 patients (28%); these included thrombocytopenia and malignant neoplasm progression in 2 patients (7%) each.

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Related Clinical Trial
NCT Number NCT03035279  Clinical Status PHASE1
Clinical Description An Open Label Phase 1 Study of SC-006 as a Single Agent and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer
Primary Endpoint
Safety assessment focuses on dose-limiting toxicities (DLTs) graded per NCI CTCAE v4.03 during the initial 21-day treatment cycle.
Other Endpoint
Efficacy endpoints include overall survival (OS) and progression-free survival (PFS) over approximately 2 years, along with pharmacokinetic parameters (Tmax, AUC, T1/2, Cmax, Ctrough) of SC-006 evaluated over 1 year. Tumor response is measured via objective response rate (ORR), clinical benefit rate (CBR), and duration of response (DOR) using RECIST v1.1 criteria.

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Experiment 2 Reporting the Activity Date of This ADC [1]
Efficacy Data progressive disease (PD)
62%
Patients Enrolled
Eligible participants must have advanced metastatic CRC refractory to ≥2 prior systemic therapies, ECOG 0-1, and adequate organ function. Key exclusions include prior PBD/IND-based drug exposure, autoimmune/immunodeficiency disorders, IBD history, or recent immunosuppressant use within 14 days prior to treatment. Combination therapy excludes patients with immune-mediated pneumonitis or transplant history.

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Administration Dosage
As of April 2019, 29 patients were enrolled (n=20 in part A and n=9 in part B). All patients experienced at least one treatment-emergent adverse event (TEAE). Two patients (7%) had dose-limiting toxicities of grade 4 thrombocytopenia. All 29 patients discontinued from the study, with study drug being discontinued for 76% of patients due to progressive disease. One death occurred in part A due to gastrointestinal hemorrhage with possible relation to SC-006. Serious TEAEs occurred in 8 patients (28%); these included thrombocytopenia and malignant neoplasm progression in 2 patients (7%) each.

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Related Clinical Trial
NCT Number NCT03035279  Clinical Status PHASE1
Clinical Description An Open Label Phase 1 Study of SC-006 as a Single Agent and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer
Primary Endpoint
Safety assessment focuses on dose-limiting toxicities (DLTs) graded per NCI CTCAE v4.03 during the initial 21-day treatment cycle.
Other Endpoint
Efficacy endpoints include overall survival (OS) and progression-free survival (PFS) over approximately 2 years, along with pharmacokinetic parameters (Tmax, AUC, T1/2, Cmax, Ctrough) of SC-006 evaluated over 1 year. Tumor response is measured via objective response rate (ORR), clinical benefit rate (CBR), and duration of response (DOR) using RECIST v1.1 criteria.

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Experiment 3 Reporting the Activity Date of This ADC [2]
Efficacy Data Objective Response Rate (ORR)
0%
Patients Enrolled
Patients with advanced metastatic or unresectable colorectal cancer.
Administration Dosage
SC-006-monotherapy, 2 to 12 ug/kg IV every 3 weeks.
Related Clinical Trial
NCT Number NCT03035279  Clinical Status Phase 1
Clinical Description An open label phase 1 study of SC-006 as a single agent and in combination with ABBV-181 in subjects with advanced colorectal cancer.
References
Ref 1 A Study of SC-006 and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer
Ref 2 Anti-NaPi2b antibody-drug conjugate lifastuzumab vedotin (DNIB0600A) compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer in a randomized, open-label, phase II study. Ann Oncol. 2018 Apr 1;29(4):917-923. doi: 10.1093/annonc/mdy023.