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Trial Title:
A Study of ZW171 in Participants With Advanced or Metastatic Mesothelin-expressing Cancers
NCT ID:
NCT06523803
Condition:
Mesothelin-expressing Advanced Cancers
Conditions: Keywords:
Advanced or Metastatic Cancers
ADC
Antibody drug conjugate
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:
ZW171
Description:
Administered per protocol requirements
Arm group label:
ZW171
Summary:
This study is being done to find out if ZW171 is safe and can treat participants with
advanced (locally advanced [inoperable] and/or metastatic) mesothelin-expressing cancers.
Detailed description:
Part 1 of the study will evaluate the safety and tolerability of ZW171. Part 2 of the
study will evaluate the anti-tumor activity of ZW171 while continuing to evaluate the
safety and tolerability.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Pathologically confirmed diagnosis of cancers with evidence of locally advanced
(unresectable) and/or metastatic disease. Cancers that are refractory to all
available standard of care (SOC) treatment, cancers for which no SOC treatment is
available, or the participant cannot tolerate or refuses SOC therapy.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Adequate cardiac left ventricular function, as defined by left ventricular ejection
fraction ≥ 50% as determined by either echocardiogram or multigated acquisition
scan.
- Adequate organ function.
Exclusion Criteria:
- Known additional malignancy that is progressing or that has required active
treatment.
- Undergone prior allogenic tissue (e.g., hematopoietic stem cell) or solid organ
transplantation within the last 5 years.
- Ongoing, clinically significant toxicity (Grade ≥ 2) associated with prior cancer
therapies, with the exception of alopecia.
- Advanced/metastatic, symptomatic, visceral spread, at risk of life-threatening
complications in the short-term (including participants with massive uncontrolled
effusion [pleural, pericardial], pulmonary lymphangitis, active unresolved bowel
obstruction, massive ascites [requiring paracentesis >2 times within 2 weeks prior
to the first dose], and over 50% liver involvement).
- Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with
exception of participants with Gilbert's Syndrome, asymptomatic gall stones, liver
metastases, or stable chronic liver disease per investigator assessment).
- Active or recurrent clinically significant autoimmune disease requiring systemic
high-dose corticosteroids or immunosuppressive drugs.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Southern California - Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90089
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Diana Hanna, MD
Email:
Principal Investigator
Facility:
Name:
Norton Cancer Institute
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Investigator:
Last name:
John Hamm, MD
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Melissa Johnson, MD
Email:
Principal Investigator
Start date:
September 30, 2024
Completion date:
December 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/NCT06523803
