General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0KYBXW
ADC Name
ZW191
Synonyms
ZW191
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Organization
Zymeworks (Originator)
Drug Status
Phase 1
Drug-to-Antibody Ratio
8
Structure
Antibody Name
Anti-FOLR1 IgG1 mAb
 Antibody Info 
Antigen Name
Folate receptor alpha (FOLR1)
 Antigen Info 
Payload Name
ZD06519
 Payload Info 
Therapeutic Target
DNA topoisomerase 1 (TOP1)
 Target Info 
Linker Name
Mc-Gly-Gly-Phe-Gly-AM
 Linker Info 
Conjugate Type
Random Cysteines
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
Endometrial cancer
1 Trials
Trial ID
NCT06555744; jRCT2031240343; EudraCT2024-512299-37; EUCT2024-512299-37-00
Lung cancer
1 Trials
Trial ID
NCT06555744; jRCT2031240343; EudraCT2024-512299-37; EUCT2024-512299-37-00
Ovarian cancer
1 Trials
Trial ID
NCT06555744; jRCT2031240343; EudraCT2024-512299-37; EUCT2024-512299-37-00
Unspecific solid tumor
1 Trials
Trial ID
NCT06555744; jRCT2031240343; EudraCT2024-512299-37; EUCT2024-512299-37-00
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT06555744
PHASE1
A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of a Folate Receptor Alpha Antibody Drug Conjugate, ZW191, in Participants With Advanced Solid Tumors

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Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Eligibility: Locally advanced/unresectable or metastatic cancer (measurable per RECIST v1.1), ECOG 0-1, LVEF ≥50%, and adequate organ function. Exclusions: active malignancies requiring treatment, prior TOPO1i ADC therapy, uncontrolled organ dysfunction (renal/liver/pancreatic), or severe active infections (including SARS-CoV-2) needing systemic therapy.

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Administration Dosage
.
Related Clinical Trial
NCT Number NCT06555744  Clinical Status PHASE1
Clinical Description A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of a Folate Receptor Alpha Antibody Drug Conjugate, ZW191, in Participants With Advanced Solid Tumors
Primary Endpoint
Primary safety outcomes (Parts 1-2) include dose-limiting toxicities (DLTs) evaluated within 3 weeks, treatment-related adverse events (AEs), special interest AEs (AESIs), serious AEs (SAEs), and Grade 3+ lab abnormalities per CTCAE v5.0. Key efficacy measures (Part 2) focus on confirmed objective response rate (ORR) by RECIST v1.1 (CR/PR).
Other Endpoint
Secondary endpoints (Parts 1-2) assess clinical benefit rate (CR/PR/non-CR non-PD/SD lasting ≥180 days), duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and best overall response (BOR). Pharmacokinetics (serum concentrations & ADA development) will be monitored throughout the study.
References
Ref 1 A Study of ZW191 in Participants With Solid Tumors