Mesothelin-expressing Advanced CancersPhase 1NCT06523803
A Study of ZW171 in Participants With Advanced or Metastatic Mesothelin-expressing Cancers
A Phase 1 study testing ZW171 in people with Mesothelin-expressing Advanced Cancers, run by Zymeworks BC Inc. at 15 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelin-expressing Advanced Cancers
- What is being tested?
- ZW171
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 30 Sep 2024to 1 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
United States7 sites
University of Colorado Health Sciences Center
Aurora, Colorado, 80045
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, 90089
Norton Cancer Institute
Louisville, Kentucky, 40202
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Icahn School of Medicine at Mount Sinai (ISMMS) - The Blavatnik Family-Chelsea Medical Center
New York, New York, 10011
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
University of Washington
Seattle, Washington, 98195
South Korea4 sites
Seoul National University Hospital
Seoul, 03080
Yonsei University Health System - Severance Hospital
Seoul, 03722
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul
United Kingdom3 sites
Guys and St Thomas' NHS Foundation Trust
London, SE1 9RT
The Christie NHS Foundation Trust
Manchester, M20 4BX
Royal Marsden Hospital
Sutton, SW3 6JJ
About this study
Official title: A Phase 1, Open-label, Multicenter Study of ZW171 in Participants With Advanced or Metastatic Ovarian Cancer, Non-small Cell Lung Cancer (NSCLC), and Other Mesothelin Expressing Cancers
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.
Read the 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.
- Conditions
- Mesothelin-expressing Advanced Cancers
- Being tested
- ZW171
- Keywords
- Advanced or Metastatic Cancers, ADC, Antibody drug conjugate
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZW171Drug
Administered per protocol requirements
| Study group | Role | What they receive |
|---|---|---|
| ZW171 | Experimental | Not described Receives: Drug: ZW171 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs; Part 1)
Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to ZW171
Measured: Up to 3 weeks
Incidence of adverse events (AEs; Parts 1 and 2)
Number of participants who experienced AEs or serious adverse events (SAEs)
Measured: Up to approximately 2 years
Incidence of cytokine release syndrome (CRS; Parts 1 and 2)
Number of participants who experienced CRS
Measured: Up to approximately 2 years
Incidence of neurotoxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS; Parts 1 and 2)
Number of participants who experienced neurotoxicity, including ICANS
Measured: Up to approximately 2 years
Incidence of clinical laboratory abnormalities (Parts 1 and 2)
Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Measured: Up to approximately 2 years
Confirmed objective response rate (Part 2)
Number of participants who achieved a best overall response of either confirmed complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Up to approximately 2 years
Secondary outcomes (7)
Confirmed objective response rate (Part 1)
Number of participants who achieved a best overall response of either confirmed CR or PR during treatment according to RECIST v1.1
Measured: Up to approximately 2 years
Duration of response (DOR; Part 2)
The time from the first objective response (CR or PR) to the first documented progressive disease (PD) per RECIST v1.1 or death within 30 days of last dose of study treatment from any cause. Only participants who achieve a confirmed response will be included in the analysis
Measured: Up to approximately 2 years
Progression-free survival (PFS), including 1-year PFS (Part 2)
The time from the first dose of study treatment to the date of first documented PD per RECIST v1.1 or death from any cause
Measured: Up to approximately 2 years
Disease control rate (DCR; Part 2)
Number of participants who achieved a best response of CR, PR, non-CR/non-PD (for participants who have only non-target lesions), or stable disease (SD) during treatment per RECIST v1.1
Measured: Up to approximately 2 years
Overall survival (OS), including 1-year OS (Part 2)
The time from the first dose of ZW171 until the date of death from any cause
Measured: Up to approximately 2 years
Serum concentration of ZW171 (Parts 1 and 2)
Maximum serum concentration and trough concentration of ZW171
Measured: Up to approximately 7 months
Incidence of anti-drug antibodies (ADAs; Parts 1 and 2)
Number of participants who develop ADAs
Measured: Up to approximately 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start30 Sep 2024
- Primary completion30 Sep 2025
- Study completion1 Oct 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesothelin-expressing Advanced CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zymeworks BC Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pranshul Chauhan, MSc, MB, BCh, BAO, Study director, Zymeworks BC Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523803
- Sponsor's protocol ID
- ZWI-ZW171-101
- Other IDs
- 2024-511119-11
- Status last verified
- Oct 2025
- First submitted
- 22 Jul 2024
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multicenter Study of ZW171 in Participants With Advanced or Metastatic Ovarian Cancer, Non-small Cell Lung Cancer (NSCLC), and Other Mesothelin Expressing Cancers
- ClinicalTrials.gov ID
- NCT06523803
- Acronym / sponsor ID
- ZWI-ZW171-101
- Conditions
- Mesothelin-expressing Advanced Cancers
- Keywords
- Advanced or Metastatic Cancers, ADC, Antibody drug conjugate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Zymeworks BC Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZW171 | Experimental | Drug: ZW171 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZW171Administered per protocol requirements | Drug | ZW171 |
Primary outcome
Incidence of dose-limiting toxicities (DLTs; Part 1)
Time frame: Up to 3 weeks
Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to ZW171
Incidence of adverse events (AEs; Parts 1 and 2)
Time frame: Up to approximately 2 years
Number of participants who experienced AEs or serious adverse events (SAEs)
Incidence of cytokine release syndrome (CRS; Parts 1 and 2)
Time frame: Up to approximately 2 years
Number of participants who experienced CRS
Incidence of neurotoxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS; Parts 1 and 2)
Time frame: Up to approximately 2 years
Number of participants who experienced neurotoxicity, including ICANS
Incidence of clinical laboratory abnormalities (Parts 1 and 2)
Time frame: Up to approximately 2 years
Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Confirmed objective response rate (Part 2)
Time frame: Up to approximately 2 years
Number of participants who achieved a best overall response of either confirmed complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
7 secondary outcomes
Confirmed objective response rate (Part 1)
Time frame: Up to approximately 2 years
Duration of response (DOR; Part 2)
Time frame: Up to approximately 2 years
Progression-free survival (PFS), including 1-year PFS (Part 2)
Time frame: Up to approximately 2 years
Disease control rate (DCR; Part 2)
Time frame: Up to approximately 2 years
Overall survival (OS), including 1-year OS (Part 2)
Time frame: Up to approximately 2 years
Serum concentration of ZW171 (Parts 1 and 2)
Time frame: Up to approximately 7 months
Incidence of anti-drug antibodies (ADAs; Parts 1 and 2)
Time frame: Up to approximately 7 months
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Mesothelin-expressing Advanced Cancers
Not yet recruitingPhase 1
A Study of Mesothelin-Targeted CAR-Mix Cells in Patients With Advanced Solid Tumors
Mesothelin-Positive Advanced Solid Tumors With Peritoneal Metastasis
Active, not recruitingPhase 1
Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer
Pancreatic Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8
Active, not recruitingPhase 1
T-Cell Therapy for Advanced Breast Cancer
Breast Cancer, Metastatic HER2-negative Breast
RecruitingPhase 1
SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma
Ovarian Cancer, Cholangiocarcinoma Recurrent
RecruitingPhase 1/2
A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression
Solid Tumor, Adult, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pranshul Chauhan, MSc, MB, BCh, BAO study director
Zymeworks BC Inc.
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZW171 in people with Mesothelin-expressing Advanced Cancers, run by Zymeworks BC Inc. at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, South Korea, United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs; Part 1) (time frame: Up to 3 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.