Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0YXBEH
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| ADC Name |
SHR-A1912
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| Synonyms |
SHR-A1912
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| Organization |
Jiangsu Hengrui Pharmaceuticals (Originator)
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
SHR-1920
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Antibody Info | ||||
| Antigen Name |
B-cell antigen receptor complex-associated protein beta chain (CD79B)
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Antigen Info | ||||
| Payload Name |
SHR9265
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Mc-Gly-Gly-Phe-Gly
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
rezetecan
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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 | ||
|---|---|---|---|---|---|---|---|---|---|
| Unspecific non-hodgkin lymphoma |
1 Trials
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
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] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05113069 | Clinical Status | Phase 1 | ||
| Clinical Description | An open-label, single-arm, multicenter, phase 1 study to estimate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1912 in patients with b-cell lymphoma. | ||||
| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | stable disease (SD) |
7%
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| Patients Enrolled |
Eligible patients (≥18 yrs) have confirmed relapsed/refractory B-cell lymphoma, ≥1 measurable lesion (nodal >1.5 cm/extranodal >1.0 cm), ECOG 0-1, and life expectancy >12 weeks. Exclusions: recent stem cell/CAR-T therapy (≤12 weeks), major surgery (≤4 weeks), anti-tumor treatment (≤2 weeks), CNS involvement, active HBV/HCV/HIV, uncontrolled infections, or severe cardiovascular disease.
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| Administration Dosage |
SHR-A1912, dose escalation and expansion.
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| Related Clinical Trial | |||||
| NCT Number | NCT05113069 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1912 for Injection as Monotherapy in Patients With B-cell Lymphoma | ||||
| Primary Endpoint |
The study evaluates AEs and DLT within the first 21 days after initial dosing to determine MTD and establish RP2D (up to ~2 years). Safety monitoring continues through all treatment cycles.
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| Other Endpoint |
harmacokinetics (Tmax, Cmax, AUC) of SHR-1912 and ADA formation are assessed within 21 days post-last dose. Efficacy outcomes (CR, ORR, DoR, DCR, PFS) are tracked for ~2 years, with OS extending to ~3 years. AEs are monitored for 12 weeks after treatment cessation.
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| Experiment 3 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | progressive disease (PD) |
11%
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| Patients Enrolled |
Eligible patients (≥18 yrs) have confirmed relapsed/refractory B-cell lymphoma, ≥1 measurable lesion (nodal >1.5 cm/extranodal >1.0 cm), ECOG 0-1, and life expectancy >12 weeks. Exclusions: recent stem cell/CAR-T therapy (≤12 weeks), major surgery (≤4 weeks), anti-tumor treatment (≤2 weeks), CNS involvement, active HBV/HCV/HIV, uncontrolled infections, or severe cardiovascular disease.
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| Administration Dosage |
SHR-A1912, dose escalation and expansion.
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| Related Clinical Trial | |||||
| NCT Number | NCT05113069 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1912 for Injection as Monotherapy in Patients With B-cell Lymphoma | ||||
| Primary Endpoint |
The study evaluates AEs and DLT within the first 21 days after initial dosing to determine MTD and establish RP2D (up to ~2 years). Safety monitoring continues through all treatment cycles.
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| Other Endpoint |
harmacokinetics (Tmax, Cmax, AUC) of SHR-1912 and ADA formation are assessed within 21 days post-last dose. Efficacy outcomes (CR, ORR, DoR, DCR, PFS) are tracked for ~2 years, with OS extending to ~3 years. AEs are monitored for 12 weeks after treatment cessation.
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| Experiment 4 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Partial Response (PR) |
19%
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| Patients Enrolled |
Eligible patients (≥18 yrs) have confirmed relapsed/refractory B-cell lymphoma, ≥1 measurable lesion (nodal >1.5 cm/extranodal >1.0 cm), ECOG 0-1, and life expectancy >12 weeks. Exclusions: recent stem cell/CAR-T therapy (≤12 weeks), major surgery (≤4 weeks), anti-tumor treatment (≤2 weeks), CNS involvement, active HBV/HCV/HIV, uncontrolled infections, or severe cardiovascular disease.
Click to Show/Hide
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| Administration Dosage |
SHR-A1912, dose escalation and expansion.
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| Related Clinical Trial | |||||
| NCT Number | NCT05113069 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1912 for Injection as Monotherapy in Patients With B-cell Lymphoma | ||||
| Primary Endpoint |
The study evaluates AEs and DLT within the first 21 days after initial dosing to determine MTD and establish RP2D (up to ~2 years). Safety monitoring continues through all treatment cycles.
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| Other Endpoint |
harmacokinetics (Tmax, Cmax, AUC) of SHR-1912 and ADA formation are assessed within 21 days post-last dose. Efficacy outcomes (CR, ORR, DoR, DCR, PFS) are tracked for ~2 years, with OS extending to ~3 years. AEs are monitored for 12 weeks after treatment cessation.
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| Experiment 5 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
56.10%
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| Patients Enrolled |
Eligible patients (≥18 yrs) have confirmed relapsed/refractory B-cell lymphoma, ≥1 measurable lesion (nodal >1.5 cm/extranodal >1.0 cm), ECOG 0-1, and life expectancy >12 weeks. Exclusions: recent stem cell/CAR-T therapy (≤12 weeks), major surgery (≤4 weeks), anti-tumor treatment (≤2 weeks), CNS involvement, active HBV/HCV/HIV, uncontrolled infections, or severe cardiovascular disease.
Click to Show/Hide
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| Administration Dosage |
SHR-A1912, dose escalation and expansion.
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| Related Clinical Trial | |||||
| NCT Number | NCT05113069 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1912 for Injection as Monotherapy in Patients With B-cell Lymphoma | ||||
| Primary Endpoint |
The study evaluates AEs and DLT within the first 21 days after initial dosing to determine MTD and establish RP2D (up to ~2 years). Safety monitoring continues through all treatment cycles.
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| Other Endpoint |
harmacokinetics (Tmax, Cmax, AUC) of SHR-1912 and ADA formation are assessed within 21 days post-last dose. Efficacy outcomes (CR, ORR, DoR, DCR, PFS) are tracked for ~2 years, with OS extending to ~3 years. AEs are monitored for 12 weeks after treatment cessation.
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| Experiment 6 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Disease control rate (DCR) |
73.20%
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| Patients Enrolled |
Eligible patients (≥18 yrs) have confirmed relapsed/refractory B-cell lymphoma, ≥1 measurable lesion (nodal >1.5 cm/extranodal >1.0 cm), ECOG 0-1, and life expectancy >12 weeks. Exclusions: recent stem cell/CAR-T therapy (≤12 weeks), major surgery (≤4 weeks), anti-tumor treatment (≤2 weeks), CNS involvement, active HBV/HCV/HIV, uncontrolled infections, or severe cardiovascular disease.
Click to Show/Hide
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| Administration Dosage |
SHR-A1912, dose escalation and expansion.
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| Related Clinical Trial | |||||
| NCT Number | NCT05113069 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1912 for Injection as Monotherapy in Patients With B-cell Lymphoma | ||||
| Primary Endpoint |
The study evaluates AEs and DLT within the first 21 days after initial dosing to determine MTD and establish RP2D (up to ~2 years). Safety monitoring continues through all treatment cycles.
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| Other Endpoint |
harmacokinetics (Tmax, Cmax, AUC) of SHR-1912 and ADA formation are assessed within 21 days post-last dose. Efficacy outcomes (CR, ORR, DoR, DCR, PFS) are tracked for ~2 years, with OS extending to ~3 years. AEs are monitored for 12 weeks after treatment cessation.
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| Experiment 7 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Complete response (CR) |
4%
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| Patients Enrolled |
Eligible patients (≥18 yrs) have confirmed relapsed/refractory B-cell lymphoma, ≥1 measurable lesion (nodal >1.5 cm/extranodal >1.0 cm), ECOG 0-1, and life expectancy >12 weeks. Exclusions: recent stem cell/CAR-T therapy (≤12 weeks), major surgery (≤4 weeks), anti-tumor treatment (≤2 weeks), CNS involvement, active HBV/HCV/HIV, uncontrolled infections, or severe cardiovascular disease.
Click to Show/Hide
|
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| Administration Dosage |
SHR-A1912, dose escalation and expansion.
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| Related Clinical Trial | |||||
| NCT Number | NCT05113069 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1912 for Injection as Monotherapy in Patients With B-cell Lymphoma | ||||
| Primary Endpoint |
The study evaluates AEs and DLT within the first 21 days after initial dosing to determine MTD and establish RP2D (up to ~2 years). Safety monitoring continues through all treatment cycles.
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| Other Endpoint |
harmacokinetics (Tmax, Cmax, AUC) of SHR-1912 and ADA formation are assessed within 21 days post-last dose. Efficacy outcomes (CR, ORR, DoR, DCR, PFS) are tracked for ~2 years, with OS extending to ~3 years. AEs are monitored for 12 weeks after treatment cessation.
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| Experiment 8 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients (≥18 yrs) include relapsed/refractory or treatment-naive B-cell NHL cases (≥1 measurable lesion: nodal >1.5cm/extranodal >1.0cm), ECOG 0-1, life expectancy >3 months. Exclusions: recent stem cell/CAR-T therapy (≤12 weeks), major surgery (≤4 weeks), active HBV/HCV/HIV, uncontrolled infections, or severe cardiovascular/CNS involvement.
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| Administration Dosage |
.
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| Related Clinical Trial | |||||
| NCT Number | NCT06104553 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase Ib/II Study of SHR-A1912 Combined With Other Therapies in Patients With B-cell Non-Hodgkin 's Lymphoma | ||||
| Primary Endpoint |
Phase 1b evaluates RP2D for SHR-A1912 combined with immunochemotherapy (selected within ~12 months) while assessing AEs up to ~24 months. Phase 2 focuses on ORR with ~24-month follow-up, with ongoing safety monitoring.
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| Other Endpoint |
Both phases measure efficacy (ORR, CRR, DOR, PFS in Phase 1b/2) and pharmacokinetics (toxin-binding/total antibodies, free toxin, ADA) over ~24 months. Safety (AE incidence/severity) and immunogenicity are studied through the follow-up period in both cohorts.
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References