Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0FKZGF
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| ADC Name |
XNW27011
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| Synonyms |
XNW27011; XNW27; ASP546C; YL203
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| Organization |
XNW Pharma (Sinovent) (Originator);MediLink Therapeutics (Originator);Astellas Pharma (Top20 MNC)
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
8
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| Structure |
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| Antibody Name |
Anti-CLDN18.2 antibody
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Antibody Info | ||||
| Antigen Name |
Claudin-18.2 (CLDN18.2)
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Antigen Info | ||||
| Payload Name |
YL0010014
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Payload Info | ||||
| Payload Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
VK*G-NHCH2-O linker
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
pelitecan
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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 | ||||
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| Unspecific solid tumor |
1 Trials
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| Oesophageal cancer |
1 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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1 Trials
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| Gastric cancer |
1 Trials
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1 Trials
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| Colorectal cancer |
1 Trials
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| Pancreatic cancer |
1 Trials
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| Biliary tract cancer |
1 Trials
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| Lung cancer |
1 Trials
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| Ovarian cancer |
1 Trials
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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) |
50%
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| Patients Enrolled |
Eligible patients are ≥18 years old with advanced solid tumors (gastric/GEJ adenocarcinoma, pancreatic, ovarian, etc.), measurable disease (RECIST 1.1), ECOG ≤2, and adequate organ function. Phase II requires CLDN18.2-positive tumors. Exclusions include prior anti-CLDN18.2 therapy, severe allergies to ADC components, uncontrolled comorbidities (cardiovascular, infections, third-space effusions), recent major surgery/radiotherapy, or pregnancy. Both phases mandate contraception compliance.
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| Administration Dosage |
As of Apr. 15, 2024, 16 pts were enrolled in 6 dose cohorts from 0.6 to 6.0 mg/kg, including 11 GC/GEJC, 2 OC, 2 PC, and 1 duodenal periampullary adenocarcinoma (ECOG 0-1, majority of pts received ≥3 lines of prior therapy).
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| Related Clinical Trial | |||||
| NCT Number | NCT06792435 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase I/II, First-in-Human Study of XNW27011 in Patients with Locally Advanced And/or Metastatic Solid Tumors | ||||
| Primary Endpoint |
This study aims to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of XNW27011 in a dose escalation phase (Phase I) for patients with locally advanced/metastatic solid tumors, assessing dose-limiting toxicities (DLTs) during the first 3-week cycle. The Phase II expansion phase will evaluate objective response rate (ORR) at RP2D, measuring complete (CR) and partial responses (PR) over approximately 2 years.
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| Other Endpoint |
Safety assessments include adverse event monitoring (NCI CTCAE v5.0), pharmacokinetic profiling (AUC, Cmax, Ctrough), immunogenicity (anti-drug antibodies), and CLDN18.2 biomarker correlation with efficacy. Phase II will further assess disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), and overall survival (OS) at RP2D over 2 years.
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| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
86%
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| Patients Enrolled |
Eligible patients are ≥18 years old with advanced solid tumors (gastric/GEJ adenocarcinoma, pancreatic, ovarian, etc.), measurable disease (RECIST 1.1), ECOG ≤2, and adequate organ function. Phase II requires CLDN18.2-positive tumors. Exclusions include prior anti-CLDN18.2 therapy, severe allergies to ADC components, uncontrolled comorbidities (cardiovascular, infections, third-space effusions), recent major surgery/radiotherapy, or pregnancy. Both phases mandate contraception compliance.
Click to Show/Hide
|
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| Administration Dosage |
As of Apr. 15, 2024, 16 pts were enrolled in 6 dose cohorts from 0.6 to 6.0 mg/kg, including 11 GC/GEJC, 2 OC, 2 PC, and 1 duodenal periampullary adenocarcinoma (ECOG 0-1, majority of pts received ≥3 lines of prior therapy).
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| Related Clinical Trial | |||||
| NCT Number | NCT06792435 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase I/II, First-in-Human Study of XNW27011 in Patients with Locally Advanced And/or Metastatic Solid Tumors | ||||
| Primary Endpoint |
This study aims to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of XNW27011 in a dose escalation phase (Phase I) for patients with locally advanced/metastatic solid tumors, assessing dose-limiting toxicities (DLTs) during the first 3-week cycle. The Phase II expansion phase will evaluate objective response rate (ORR) at RP2D, measuring complete (CR) and partial responses (PR) over approximately 2 years.
Click to Show/Hide
|
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| Other Endpoint |
Safety assessments include adverse event monitoring (NCI CTCAE v5.0), pharmacokinetic profiling (AUC, Cmax, Ctrough), immunogenicity (anti-drug antibodies), and CLDN18.2 biomarker correlation with efficacy. Phase II will further assess disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), and overall survival (OS) at RP2D over 2 years.
Click to Show/Hide
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