Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06555744




Registration number
NCT06555744
Ethics application status
Date submitted
13/08/2024
Date registered
15/08/2024

Titles & IDs
Public title
A Study of ZW191 in Participants With Solid Tumors
Scientific title
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
Secondary ID [1] 0 0
2024-512299-37-00
Secondary ID [2] 0 0
ZWI-ZW191-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZW191

Experimental: ZW191 -


Treatment: Drugs: ZW191
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose-limiting toxicities (DLTs; Part 1)
Timepoint [1] 0 0
Up to 3 weeks
Primary outcome [2] 0 0
Incidence of adverse events (AEs; Parts 1 and 2)
Timepoint [2] 0 0
Up to approximately 2 years
Primary outcome [3] 0 0
Incidence of clinical laboratory abnormalities (Parts 1 and 2)
Timepoint [3] 0 0
Up to approximately 2 years
Primary outcome [4] 0 0
Confirmed objective response rate (Part 2)
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Confirmed objective response rate (Part 1)
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Clinical benefit rate (Parts 1 and 2)
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
Duration of response (DOR; Part 2)
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Disease control rate (DCR; Part 2)
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [5] 0 0
Progression-free survival (PFS; Part 2)
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Best overall response (BOR; Part 2)
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
Serum or plasma concentration and PK parameters of ZW191 (Parts 1 and 2)
Timepoint [7] 0 0
Up to approximately 2 years
Secondary outcome [8] 0 0
Incidence of anti-drug antibodies (ADAs; Parts 1 and 2)
Timepoint [8] 0 0
Up to approximately 2 years

Eligibility
Key inclusion criteria
* Pathologically or cytologically confirmed diagnosis of cancers with evidence of locally advanced (unresectable), recurrent and/or metastatic disease.
* Measurable disease per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
* Adequate cardiac function: Cardiac left ventricular function, as defined by left ventricular ejection fraction (LVEF) = 50% as determined by either echocardiogram (ECHO) or multigated acquisition scan (MUGA).
* Other adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known additional malignancy that is progressing or requires active treatment or may interfere with study endpoints.
* Has received prior Topoisomerase I inhibitor(TOPO1i) antibody drug conjugate treatment, regardless of washout period.
* Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease.
* Severe chronic or active infections (including known active SARS-CoV-2 infection) requiring systemic therapy, including antibacterial, antifungal, or antiviral therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
145
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
WA 6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
United States of America
State/province [2] 0 0
Virginia
Country [3] 0 0
Japan
State/province [3] 0 0
Saitama
Country [4] 0 0
Japan
State/province [4] 0 0
Tokyo
Country [5] 0 0
Singapore
State/province [5] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Zymeworks BC Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joseph Woolery, PharmD, BCOP
Address 0 0
Zymeworks BC Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Zymeworks Clinical Trial Resource
Address 0 0
Country 0 0
Phone 0 0
(206) 237-1030
Fax 0 0
Email 0 0
medinfo@zymeworks.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06555744