Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0LSXKR
|
|||||
|---|---|---|---|---|---|---|
| ADC Name |
JS107
|
|||||
| Synonyms |
JS107
Click to Show/Hide
|
|||||
| Organization |
TopAlliance Biosciences (Junshi Biosciences) (Originator)
|
|||||
| Drug Status |
Phase 3
|
|||||
| Drug-to-Antibody Ratio |
3.6
|
|||||
| Antibody Name |
Anti-CLDN18.2 mAb
|
Antibody Info | ||||
| Antigen Name |
Claudin-18.2 (CLDN18.2)
|
Antigen Info | ||||
| Payload Name |
Monomethyl auristatin E
|
Payload Info | ||||
| Payload Target |
Microtubule (MT)
|
Target Info | ||||
| Linker Name |
Maleimide linker of vc PAB
|
Linker Info | ||||
| Conjugate Type |
Random Cysteines
|
|||||
2027 Update
The indication landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
| Indication | Phase 1 | Phase 2 | Phase 3 | Approved | ||
|---|---|---|---|---|---|---|
| Unspecific solid tumor |
1 Trials
|
|||||
| Gastroesophageal junction adenocarcinoma |
1 Trials
|
|||||
| Gastric cancer |
1 Trials
|
|||||
| Pancreatic 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 |
Key eligibility criteria: Patients aged 18-75 with histologically confirmed locally advanced/metastatic solid tumors, ECOG 0-1, measurable lesions, and adequate organ function. Major exclusions: prior CLDN18.2-targeted therapy, severe allergies to JS107 components, recent anticancer treatments (within 4 weeks), uncontrolled infections (HBV/HCV/HIV), symptomatic CNS metastases, or significant cardiopulmonary comorbidities.
Click to Show/Hide
|
||||
| Administration Dosage |
.
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT05657418 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of JS107 in Patients With Advanced Pancreatic Cancer | ||||
| Primary Endpoint |
Primary endpoints focus on determining the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for JS107 monotherapy and combination therapy, with evaluation timelines up to 12 and 24 months respectively from first patient enrollment.
|
||||
| Other Endpoint |
Secondary objectives include pharmacokinetic analysis of drug plasma concentrations, immunogenicity assessment (ADA/Nab incidence and titers), and efficacy evaluation through objective response rate (ORR) per RECIST v1.1 criteria, all monitored over 24 months.
|
||||
| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Key eligibility: Adults (18-75) with histologically confirmed advanced/metastatic solid tumors (ECOG 0-1, measurable lesions). Major exclusions: prior CLDN18.2 therapy, severe allergies to JS107 components, recent anticancer treatments (4 weeks), active infections (HBV/HCV/HIV/TB), uncontrolled CNS metastases, significant cardiopulmonary disease, or autoimmune disorders.
Click to Show/Hide
|
||||
| Administration Dosage |
JS107, i.v., q3w
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT05502393 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of JS107 in Patients With Advanced Solid Tumors | ||||
| Primary Endpoint |
Primary endpoints include MTD determination (12 months) and RP2D establishment (24 months) for JS107 monotherapy/combination therapy in advanced solid tumor patients.
|
||||
| Other Endpoint |
Secondary objectives cover PK analysis (drug concentrations), immunogenicity (ADA/Nab incidence/titers), and efficacy (ORR per RECIST v1.1), all monitored over 24 months.
|
||||
References