Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0XBJHU
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| ADC Name |
LY3076226
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| Synonyms |
LY3076226
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| Organization |
ImmunoGen (Top20 MNC) (Originator);Eli Lilly (Top20 MNC)
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| Drug Status |
Phase 1 (discontinued)
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| Structure |
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| Antibody Name |
IMC-D11
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Antibody Info | ||||
| Antigen Name |
Fibroblast growth factor receptor 3 (FGFR3)
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Antigen Info | ||||
| Payload Name |
DM4
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Sulfo-SPDB
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Linker Info | ||||
| Conjugate Type |
Random Lysines
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| Combination Type |
soravtansine
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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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| Unspecific solid tumor |
1 Trials
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| Urothelial cancer |
1 Trials
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General Information of The Activity Data Related to This ADC
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 participants had advanced/metastatic cancer (Part B: FGFR3-altered bladder cancer), adequate organ function, and resolved prior treatment toxicities (Grade ≤1). Exclusions included recent investigational therapy, corneal/skin disorders (Grade ≥2), active infections, significant cardiac conditions (QTcF >480ms, NYHA III/IV), CNS metastases requiring steroids, or secondary malignancies impacting study interpretation. Reproductive-age participants adhered to contraception protocols.
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| Administration Dosage |
Part A (dose escalation in advanced cancer): LY3076226 administered intravenously (IV) on day 1 of each 21 day cycle. Part B (dose expansion in advanced urothelial carcinoma): LY3076226 administered IV on day 1 of each 21 day cycle.
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| Related Clinical Trial | |||||
| NCT Number | NCT02529553 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 Study of LY3076226, a Fibroblast Growth Factor Receptor 3 (FGFR3) Antibody-Drug Conjugate, in Patients With Advanced or Metastatic Cancer | ||||
| Primary Endpoint |
The MTD of LY3076226 was determined as the highest dose with <33% probability of DLT during Cycle 1 (21 days), establishing a safe dosing threshold for subsequent phases.
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| Other Endpoint |
PK analysis for Cmax and AUC was conducted pre- and postdose (0.05-72 hours) in Cycles 1 and 3. Tumor response (CR/PR per RECIST 1.1) was assessed through Cycle 3, day 21, with CR requiring complete lesion disappearance and PR a ≥30% target lesion reduction.
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