Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0GNXLK
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| ADC Name |
SHR-4849
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| Synonyms |
SHR-4849; IDE849; HRA00130-C004
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| Organization |
Jiangsu Hengrui Pharmaceuticals (Originator);IDEAYA Biosciences
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| Drug Status |
Phase 2
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| Drug-to-Antibody Ratio |
8
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| Structure |
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| Antibody Name |
SHR-2495
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Antibody Info | ||||
| Antigen Name |
Delta-like protein 3 (DLL3)
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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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| Lung cancer |
1 Trials
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| Unspecific solid tumor |
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 subjects were 18-75 years with advanced solid tumors (measurable per RECIST 1.1), ECOG 0-1, life expectancy ≥3 months, and adequate organ function. Key exclusions: CNS metastasis, recent malignancies (5 years), uncontrolled pain/effusions, severe CVD/interstitial lung disease, active HBV/HCV/HIV, unresolved prior toxicities (CTCAE >Grade 1), recent anticancer therapy/surgery (4 weeks), pregnancy, or drug allergies. Additional exclusions per investigator discretion.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06443489 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I ,Open-label, Multicenter Clinical Study to Evaluate the Safety, Tolerability , Pharmacokinetics and Efficacy of SHR-4849 in Patients With Advanced Solid Tumors | ||||
| Primary Endpoint |
The study assessed dose-limiting toxicities (DLTs) during a 21-day observation period post-dosing, along with AEs/SAEs graded per NCI-CTCAE v5.0 monitored for 24 months. The MTD/MAD and RP2D were determined after subjects in escalation/expansion phases completed ≥1 dosing cycle (24-month follow-up).
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| Other Endpoint |
Efficacy outcomes included ORR (CR+PR), DCR (CR+PR+SD), DoR (time to progression/death), and PFS (treatment-initiation to progression/death)-all per RECIST 1.1 over 24 months-plus OS (30-month follow-up from treatment initiation).
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