Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0YXBEH)
| ADC Name |
SHR-A1912
|
|||||
|---|---|---|---|---|---|---|
| Synonyms |
SHR-A1912
Click to Show/Hide
|
|||||
| Organization |
Jiangsu Hengrui Pharmaceuticals (Originator)
|
|||||
| Drug Status |
Phase 3
|
|||||
| Drug-to-Antibody Ratio |
4
|
|||||
| Structure |
|
|||||
|
|
||||||
| Antibody Name |
SHR-1920
|
Antibody Info | ||||
| Antigen Name |
B-cell antigen receptor complex-associated protein beta chain (CD79B)
|
Antigen Info | ||||
| Payload Name |
SHR9265
|
Payload Info | ||||
| Payload Target |
DNA topoisomerase 1 (TOP1)
|
Target Info | ||||
| Linker Name |
Mc-Gly-Gly-Phe-Gly
|
Linker Info | ||||
| Conjugate Type |
Random Cysteines
|
|||||
| Combination Type |
rezetecan
|
|||||
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
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 | stable disease (SD) |
7%
|
|||
| 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
|
||||
| Administration Dosage |
SHR-A1912, dose escalation and expansion.
|
||||
| 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.
|
||||
| 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.
|
||||
| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | progressive disease (PD) |
11%
|
|||
| 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
|
||||
| Administration Dosage |
SHR-A1912, dose escalation and expansion.
|
||||
| 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.
|
||||
| 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.
|
||||
| Experiment 3 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Partial Response (PR) |
19%
|
|||
| 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
|
||||
| Administration Dosage |
SHR-A1912, dose escalation and expansion.
|
||||
| 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.
|
||||
| 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.
|
||||
| Experiment 4 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
56.10%
|
|||
| 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
|
||||
| Administration Dosage |
SHR-A1912, dose escalation and expansion.
|
||||
| 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.
|
||||
| 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.
|
||||
| Experiment 5 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
73.20%
|
|||
| 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
|
||||
| Administration Dosage |
SHR-A1912, dose escalation and expansion.
|
||||
| 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.
|
||||
| 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.
|
||||
| Experiment 6 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Complete response (CR) |
4%
|
|||
| 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
|
||||
| Administration Dosage |
SHR-A1912, dose escalation and expansion.
|
||||
| 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.
|
||||
| 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.
|
||||
| Experiment 7 Reporting the Activity Date of This ADC | [2] | ||||
| 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.
Click to Show/Hide
|
||||
| Administration Dosage |
.
|
||||
| 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.
|
||||
| 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.
|
||||
| Experiment 8 Reporting the Activity Date of This ADC | [3] | ||||
| 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. | ||||
References