Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0JNXDB
ADC Name
XMT-1592
Synonyms
XMT-1592
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Organization
Mersana Therapeutics (Originator);Synaffix
Drug Status
Phase 1 (discontinued)
Drug-to-Antibody Ratio
6
Structure
Antibody Name
Anti-NaPi-2b antibody
  Antibody Info 
Antigen Name
Sodium-dependent phosphate transport protein 2B (SLC34A2)
  Antigen Info 
Payload Name
AF-HPA
  Payload Info 
Therapeutic Target
Microtubule (MT)
  Target Info 
Linker Name
Cys-13 ADC linker
  Linker Info 
Conjugate Type
Enzymatic Catalysis
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
Lung cancer
1 Trials
Trial ID
NCT04396340
Ovarian cancer
1 Trials
Trial ID
NCT04396340
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT04396340
PHASE1
A Phase 1b, First-in-Human, Dose Escalation and Expansion Study of XMT-1592 In Patients With Solid Tumors Likely to Express NaPi2b
Undisclosed  NCT04396340
Phase 1/2
A phase 1b, first-in-human, dose escalation and expansion study of XMT-1592 in patients with solid tumors likely to express NAPI2B.
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Eligible patients (ECOG 0-1) must have measurable disease, adequate organ function, and provide tumor tissue for NaPi2b testing (fresh biopsy in expansion cohorts if feasible). Key exclusions: major surgery/systemic therapy within 28 days, untreated/progressive brain metastases, active infections (HIV/HBV/HCV), severe systemic illness (e.g., uncontrolled cardiovascular/pulmonary disease), prior auristatin/maytansinoid ADC treatment, or pregnancy. NSCLC and ovarian cancer (non-mucinous subtype) are specific cohorts.

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Administration Dosage
XMT-1592 will be administered once every 21 or 28 days until disease progression, unacceptable toxicity, or either the patient or study physician determines it is in the best interest of the patient to discontinue participation in the study.
Related Clinical Trial
NCT Number NCT04396340  Clinical Status PHASE1
Clinical Description A Phase 1b, First-in-Human, Dose Escalation and Expansion Study of XMT-1592 In Patients With Solid Tumors Likely to Express NaPi2b
Primary Endpoint
The study evaluates the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of XMT-1592 over 36 weeks, based on dose-limiting toxicities (DLTs) and adverse events, alongside concomitant medication use.
Other Endpoint
Key pharmacokinetic parameters (Tmax, Cmax, AUC) are assessed daily for the first week, then weekly until 21 days post-dose, and before/after subsequent doses. Tumor response (RECIST 1.1) is monitored every 6 weeks, while anti-drug and neutralizing antibodies are analyzed every 3 weeks initially, then every 6 weeks up to 36 weeks.
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT04396340  Clinical Status Phase 1/2
Clinical Description A phase 1b, first-in-human, dose escalation and expansion study of XMT-1592 in patients with solid tumors likely to express NAPI2B.
References
Ref 1 First-in-Human Study of XMT-1592 in Patients With Ovarian Cancer and NSCLC Likely to Express NaPi2b
Ref 2 A Phase 1b, First-in-Human, Dose Escalation and Expansion Study of XMT-1592 In Patients With Solid Tumors Likely to Express NaPi2b, NCT04396340