General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0AZLBZ
ADC Name
LY4052031
Synonyms
LY4052031
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Organization
Eli Lilly (Top20 MNC) (Originator)
Drug Status
Phase 1 (discontinued)
Drug-to-Antibody Ratio
8
Antibody Name
Anti-Nectin-4 IgG1 Fc-silent mAb
 Antibody Info 
Antigen Name
Nectin-4 (NECTIN4)
 Antigen Info 
Payload Name
LSN3889710
 Payload Info 
Therapeutic Target
DNA topoisomerase 1 (TOP1)
 Target Info 
Linker Name
A cleavable peptide linker
 Linker Info 
Conjugate Type
Random Cysteines
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
Breast cancer
1 Trials
Trial ID
NCT06465069; jRCT2031240303; EudraCT2024-512927-36; EUCT2024-512927-36-00; CTR20260134
Cervical cancer
1 Trials
Trial ID
NCT06465069; jRCT2031240303; EudraCT2024-512927-36; EUCT2024-512927-36-00; CTR20260134
Head and neck cancer
1 Trials
Trial ID
NCT06465069; jRCT2031240303; EudraCT2024-512927-36; EUCT2024-512927-36-00; CTR20260134
Kidney cancer
1 Trials
Trial ID
NCT06465069; jRCT2031240303; EudraCT2024-512927-36; EUCT2024-512927-36-00; CTR20260134
Lung cancer
1 Trials
Trial ID
NCT06465069; jRCT2031240303; EudraCT2024-512927-36; EUCT2024-512927-36-00; CTR20260134
Oesophageal cancer
1 Trials
Trial ID
NCT06465069; jRCT2031240303; EudraCT2024-512927-36; EUCT2024-512927-36-00; CTR20260134
Ovarian cancer
1 Trials
Trial ID
NCT06465069; jRCT2031240303; EudraCT2024-512927-36; EUCT2024-512927-36-00; CTR20260134
Pancreatic cancer
1 Trials
Trial ID
NCT06465069; jRCT2031240303; EudraCT2024-512927-36; EUCT2024-512927-36-00; CTR20260134
Prostate cancer
1 Trials
Trial ID
NCT06465069; jRCT2031240303; EudraCT2024-512927-36; EUCT2024-512927-36-00; CTR20260134
Urothelial cancer
1 Trials
Trial ID
NCT06465069; jRCT2031240303; EudraCT2024-512927-36; EUCT2024-512927-36-00; CTR20260134
ADC-specific functional property(2027 Update)
Bystander Killing Effect
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Bystander Killing Effect Description Reference
yes
Additionally, bystander activity exerted by LY4052031 on antigen negative cells co-cultured with antigen positive cells was greater than that observed with the clinical benchmark enfortumab vedotin-ejfv.

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[1]
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT06465069
PHASE1
A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [2]
Patients Enrolled
Eligible participants include those with specific solid tumors (separate cohort requirements apply), ECOG 0-1, and adequate tumor tissue availability. Major exclusions include uncontrolled CNS metastases, cardiovascular disease, severe prior toxicities, QTcF ≥470 ms, and active corneal/pulmonary conditions, with additional enfortumab vedotin-related restrictions for certain cohorts.

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Administration Dosage
.
Related Clinical Trial
NCT Number NCT06465069  Clinical Status PHASE1
Clinical Description A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors
Primary Endpoint
Phase 1a aims to determine the Recommended Phase 2 Dose (RP2D) of LY4052031 by evaluating dose-limiting toxicities (DLTs) within Cycle 1 (21 days). Phase 1b assesses antitumor activity through Overall Response Rate (ORR) per RECIST 1.1 over approximately 48 months.
Other Endpoint
Key evaluations include pharmacokinetics (PK) parameters (Cmin, AUC) during Cycle 1 and antitumor activity metrics (ORR, DOR, TTR, PFS, DCR, OS) per RECIST 1.1 tracked over 48 months to comprehensively characterize LY4052031's clinical profile.
References
Ref 1 Abstract 1872: A next generation treatment for Nectin-4 positive cancers - Preclinical characterization of LY4052031, an anti-Nectin-4 antibody, conjugated to a novel camptothecin payload
Ref 2 A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors