Payload Information
General Information of This Payload
| Payload ID | PAY0NQLJJ |
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| Name | SG3312 (SC-DR003) |
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| Target | Human deoxyribonucleic acid (hDNA) | |||||
| Structure |
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Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
SC-006 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | stable disease (SD) |
34%
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| 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 | Phase 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
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| Primary Endpoint |
Safety assessment focuses on dose-limiting toxicities (DLTs) graded per NCI CTCAE v4.03 during the initial 21-day treatment cycle.
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| 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%
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| 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.
Click to Show/Hide
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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.
Click to Show/Hide
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| Related Clinical Trial | |||||
| NCT Number | NCT03035279 | Phase 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
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| Primary Endpoint |
Safety assessment focuses on dose-limiting toxicities (DLTs) graded per NCI CTCAE v4.03 during the initial 21-day treatment cycle.
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| 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%
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| Patients Enrolled |
Patients with advanced metastatic or unresectable colorectal cancer.
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| Administration Dosage |
SC-006-monotherapy, 2 to 12 ug/kg IV every 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT03035279 | Phase 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.
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References