Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0VEKFU
|
|||||
|---|---|---|---|---|---|---|
| ADC Name |
LY-4170156
|
|||||
| Synonyms |
LY-4170156; MBK 103; MBK-103; MBK103
Click to Show/Hide
|
|||||
| 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
|
||||||||
| Colorectal cancer |
1 Trials
|
||||||||
| Endometrial cancer |
1 Trials
|
||||||||
| Ovarian cancer |
1 Trials
|
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 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.
Click to Show/Hide
|
||||
| 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).
Click to Show/Hide
|
||||
| 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.
Click to Show/Hide
|
||||
| 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.
Click to Show/Hide
|
||||
