Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0FGLFW
|
|||||
|---|---|---|---|---|---|---|
| ADC Name |
ATG-022
|
|||||
| Synonyms |
ATG-022; ATG 022; ATN-022; ATG-022 ADC
Click to Show/Hide
|
|||||
| Organization |
Antengene (Originator)
|
|||||
| Drug Status |
Phase 1/2
|
|||||
| Drug-to-Antibody Ratio |
4
|
|||||
| Structure |
|
|||||
| Antibody Name |
Anti-CLDN18.2 antibody
|
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 |
Mc-Val-Cit-PABC
|
Linker Info | ||||
| Conjugate Type |
Random Cysteines
|
|||||
| Combination Type |
vedotin
|
|||||
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
|
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] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
41.70%
|
|||
| Patients Enrolled |
Eligible participants were adults with advanced solid tumors (Claudin 18.2+ in expansion phase), measurable disease per RECIST 1.1, adequate organ function, and willingness for tumor biopsy. Exclusions included CNS involvement, prior Claudin 18.2 therapy, active infections, recent anticancer treatments, transplants, or other conditions compromising protocol adherence.
Click to Show/Hide
|
||||
| Administration Dosage |
A treatment cycle of ATG-022 will be defined as 21 days. Dosing will begin at 0.3 mg/kg once every 3 weeks (Q3W) with 1 subject ,the following dose cohorts (0.9, 1.8, 2.4, 3.0, and 3.6 mg/kg Q3W) will require at least 3 and up to 6 evaluable subjects by using dose escalation plan of "3+3" design.
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT05718895 | Clinical Status | PHASE1 | ||
| Clinical Description | An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced/Metastatic Solid Tumors | ||||
| Primary Endpoint |
The study assessed dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) during the initial 21-day period in dose escalation cohorts.
|
||||
| Other Endpoint |
Efficacy outcomes included progression-free survival (PFS), overall response rate (ORR), and duration of response (DOR), all evaluated 12 months post-enrollment of the last subject across study cohorts.
|
||||
| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
100%
|
|||
| Patients Enrolled |
Eligible participants were adults with advanced solid tumors (Claudin 18.2+ in expansion phase), measurable disease per RECIST 1.1, adequate organ function, and willingness for tumor biopsy. Exclusions included CNS involvement, prior Claudin 18.2 therapy, active infections, recent anticancer treatments, transplants, or other conditions compromising protocol adherence.
Click to Show/Hide
|
||||
| Administration Dosage |
A treatment cycle of ATG-022 will be defined as 21 days. Dosing will begin at 0.3 mg/kg once every 3 weeks (Q3W) with 1 subject ,the following dose cohorts (0.9, 1.8, 2.4, 3.0, and 3.6 mg/kg Q3W) will require at least 3 and up to 6 evaluable subjects by using dose escalation plan of "3+3" design.
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT05718895 | Clinical Status | PHASE1 | ||
| Clinical Description | An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced/Metastatic Solid Tumors | ||||
| Primary Endpoint |
The study assessed dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) during the initial 21-day period in dose escalation cohorts.
|
||||
| Other Endpoint |
Efficacy outcomes included progression-free survival (PFS), overall response rate (ORR), and duration of response (DOR), all evaluated 12 months post-enrollment of the last subject across study cohorts.
|
||||
| Experiment 3 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05718895 | Clinical Status | Phase 1 | ||
| Clinical Description | An open, multi-center, phase 1 clinical study of ATG 022 in patients with advanced/metastatic solid tumors. | ||||
References