Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0MOPNM
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| ADC Name |
SHR-1826
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| Synonyms |
SHR-1826
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| Organization |
Jiangsu Hengrui Pharmaceuticals (Originator)
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| Drug Status |
Phase 2
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| Drug-to-Antibody Ratio |
5.3
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| Structure |
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| Antibody Name |
A humanized anti-c-MET IgG2 mAb
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Antibody Info | ||||
| Antigen Name |
Hepatocyte growth factor receptor (MET); Macrophage-stimulating protein receptor (MST1R)
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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 | ||||
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| Liver cancer |
1 Trials
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| Lung cancer |
1 Trials
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1 Trials
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| Unspecific solid tumor |
1 Trials
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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] | ||||
| Patients Enrolled |
Eligible NSCLC patients aged 18-75 with ECOG 0-1, measurable lesions (RECIST v1.1), and adequate organ function must provide tumor tissue. Excluded are those with CNS metastasis, recent major surgery, unresolved toxicities (>CTCAE v5.0 Grade 2), active HBV/HCV, uncontrolled cardiovascular disease, or prior malignancies within 5 years. Pregnancy and inadequate contraception are also exclusionary.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06754930 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer | ||||
| Primary Endpoint |
The study assesses the Recommended Phase II Dose (RP2D) alongside safety and efficacy through Adverse Events (AEs) and Objective Response Rate (ORR) over an average of 1 year from screening to study completion.
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| Other Endpoint |
Secondary outcomes include Disease Control Rate (DCR), Duration of Response (DoR), Progression-Free Survival (PFS), and Overall Survival (OS). Pharmacokinetics (blood concentrations of SHR-1826 and free toxin) and immunogenicity (anti-drug antibodies, ADA) will also be evaluated throughout the study, spanning approximately 1 year.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible NSCLC patients must have ECOG 0-1, measurable lesions (RECIST v1.1), adequate organ function, and provide tumor samples. Key exclusions include active CNS metastases, interstitial pneumonitis, recent therapies/infections, unresolved toxicities (>CTCAE v5.0 Grade 1), HIV positivity, or other investigators' safety concerns.
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| Administration Dosage |
SHR-1826 Administration by intravenous infusion for a cycle of 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06844474 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-1826 for Injection in Patients With NSCLC | ||||
| Primary Endpoint |
The study primarily evaluates safety (incidence/severity of AEs/SAEs) and efficacy (Overall Response Rate - ORR) over approximately 2 years of treatment duration.
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| Other Endpoint |
Secondary endpoints include treatment duration effects like Duration of Response (DoR), Disease Control Rate (DCR), Progression-Free Survival (PFS) over ~2 years, with Overall Survival (OS) monitored for up to 5 years post-enrollment.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients (18-75 years, ECOG 0-1) must have histologically confirmed advanced/metastatic solid tumors (measurable per RECIST v1.1) and adequate organ function. Key exclusions: active CNS metastases, prior ADC therapy, unresolved AEs (>CTCAE v5.0 Grade 1), uncontrolled infections/cardiovascular diseases, recent major surgery/radiotherapy, or conditions compromising study safety per investigator judgment. Contraception is mandatory.
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| Administration Dosage |
dose is calculated based on the subjects' baseline weight.
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| Related Clinical Trial | |||||
| NCT Number | NCT06094556 | Clinical Status | PHASE1 | ||
| Clinical Description | A Multicenter, Open Phase I Clinical Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-1826 for Injection in Patients With Advanced Solid Tumors | ||||
| Primary Endpoint |
The primary objectives include assessing Dose-Limiting Toxicity (DLT) over 21 days, determining the Maximum Tolerated Dose (MTD) or Maximum-Administered Dose within ~1 year, and establishing the Recommended Phase 2 Dose (RP2D) over ~2 years to evaluate safety and efficacy during dose escalation.
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| Other Endpoint |
Pharmacokinetic (PK) analysis of SHR-1826 covers Cmax, Tmax, AUC, t1/2, MRT, CL, and Vss over ~2 years alongside immunogenicity (anti-drug antibodies). Preliminary efficacy endpoints include ORR, DoR, DCR, PFS, and OS, all measured over ~2 years.
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| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible patients (18-75 years, ECOG 0-1, advanced solid tumors, measurable lesions per RECIST v1.1) must meet organ function criteria; exclusions include CNS metastasis, prior topoisomerase I inhibitor/EGFR-c-Met therapy, unresolved toxicities >Grade 2, active infections, or uncontrolled comorbidities.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06703177 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | Phase IB/II Study of Safety, Tolerability and Efficacy of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors | ||||
| Primary Endpoint |
Phase 1 primary outcomes include RP2D determination, AE assessment, and Phase 2 ORR evaluation, all monitored from screening to study completion (average 1 year).
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| Other Endpoint |
Phase 1/2 secondary measures encompass ORR, DCR, DoR, PFS, OS, ADA, SHR-1826 blood concentration, free toxin SHR169265 levels, and AE tracking, with consistent timeframes across both phases.
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References