General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0VEKFU
ADC Name
LY-4170156
Synonyms
LY-4170156; MBK 103; MBK-103; MBK103
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Organization
Mablink Bioscience
Drug Status
Phase 1
Drug-to-Antibody Ratio
8
Structure
Antibody Name
Fc-silent FRalpha specific humanized IgG1 antibody
 Antibody Info 
Antigen Name
Folate receptor alpha (FOLR1)
 Antigen Info 
Payload Name
Exatecan
 Payload Info 
Therapeutic Target
DNA topoisomerase 1 (TOP1)
 Target Info 
Linker Name
Mal-Polysarcosine10-Val-Ala-PABC
 Linker Info 
Conjugate Type
Lysine cuopling
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
Cervical cancer
1 Trials
Trial ID
NCT06400472
Colorectal cancer
1 Trials
Trial ID
NCT06400472
Endometrial cancer
1 Trials
Trial ID
NCT06400472
Ovarian cancer
1 Trials
Trial ID
NCT06400472
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  NCT06400472
PHASE1
A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor alpha-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors

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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 [1]
Patients Enrolled
Eligible participants include those with specific solid tumors like ovarian, endometrial, cervical, NSCLC, TNBC, pancreatic, or colorectal cancer across various cohorts. Exclusion criteria involve uncontrolled CNS metastases, carcinomatous meningitis, active infections, corneal issues, unresolved toxicities, cardiovascular disease, prolonged QTcF (≥470 ms), pneumonitis history, or pregnancy/breastfeeding.

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Administration Dosage
The study has 2 phases: phase 1a dose escalation/dose optimization and phase 1b dose expansion. Dose escalation follows the mTPI-2 method. Pts are allowed to backfill to previously cleared dose levels that have demonstrated therapeutically relevant exposures or shown direct evidence of clinical activity. LY4170156 is administered intravenously Q3W; DLT evaluation period is 21 days. In dose expansion, pts with select tumor types are enrolled into 4 cohorts: PROC with high (cohort B1) and moderate/low (cohort B2) FRalpha expression and select advanced/metastatic non-ovarian cancer with high (cohort C1) and moderate/low FRalpha expression (cohort C2).

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Related Clinical Trial
NCT Number NCT06400472  Clinical Status PHASE1
Clinical Description A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor alpha-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors
Primary Endpoint
Phase 1a focuses on determining the recommended phase 2 dose (RP2D) of LY4170156, either as monotherapy or in combination with bevacizumab or carboplatin, measured by dose-limiting toxicities (DLTs) over a 21-day cycle. Phase 1b evaluates the antitumor activity of LY4170156 monotherapy, with overall response rate (ORR) assessed via RECIST 1.1 over approximately 48 months.

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Other Endpoint
This section characterizes the pharmacokinetics (PK) of LY4170156 through metrics like minimum plasma concentration (Cmin) and area under the curve (AUC) over 84 days. Additionally, it evaluates preliminary antitumor activity, including ORR, duration of response (DOR), time to response (TTR), progression-free survival (PFS), and disease control rate (DCR), all assessed via RECIST 1.1, with or without bevacizumab/carboplatin, over approximately 48 months.

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References
Ref 1 A Study of LY4170156 in Participants With Selected Advanced Solid Tumors