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Trial Title:
A Study of ZW191 in Participants With Solid Tumors
NCT ID:
NCT06555744
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Advanced or Metastatic Cancers
ADC
Folate alpha receptor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ZW191
Description:
Administered intravenously
Arm group label:
ZW191
Summary:
The purpose of this study is to find out if ZW191 is safe and can treat participants with
advanced cancers, including ovarian, endometrial, and non-small cell lung cancers.
Detailed description:
Part 1 of the study will evaluate the safety and tolerability of ZW191. Part 2 of the
study will further evaluate safety and explore the potential anti-tumor activity of
ZW191.
Criteria for eligibility:
Criteria:
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.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
NEXT Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Investigator:
Last name:
David Sommerhalder, MD
Email:
Principal Investigator
Facility:
Name:
NEXT Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Alexander Spira, MD, PhD, FACP
Email:
Principal Investigator
Facility:
Name:
Linear Clinical Research
Address:
City:
Nedlands
Zip:
WA 6009
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Tarek Meniawy, MBBS, PhD
Email:
Principal Investigator
Facility:
Name:
Saitama Medical University International Medical Center
Address:
City:
Saitama
Zip:
350-1298
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Kosei Hasegawa, MD, PhD
Email:
Principal Investigator
Start date:
October 30, 2024
Completion date:
January 2027
Lead sponsor:
Agency:
Zymeworks BC Inc.
Agency class:
Industry
Source:
Zymeworks BC Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06555744
