Advanced Solid TumorsPhase 1NCT06555744
A Study of ZW191 in Participants With Solid Tumors
A Phase 1 study testing ZW191 in people with Advanced Solid Tumors, run by Zymeworks BC Inc. at 27 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- ZW191
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 27 sitesin 6 countries
- Study dates
- 30 Oct 2024to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 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.
Who cannot join
- 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.
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
South Korea7 sites
National Cancer Center
Goyang-si, 10408
Seoul National University Bundang Hospital
Seongnam-si, 13620
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Gangnam Severance Hospital
Seoul, 6273
Spain6 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario Reina Sofia
Córdoba, 14004
Clínica Universidad de Navarra
Madrid, 28027
NEXT Oncology Madrid
Madrid, 28223
Fundacion Instituto Valenciano de Oncologia (IVO)
Valencia, 46009
Hospital Clinico Universitario de Valencia
Valencia, 46010
United States5 sites
The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Columbus, Ohio, 43210
NEXT Virginia
Fairfax, Virginia, 22031
Yale University
New Haven, Connecticut, 06510
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
NEXT Oncology
San Antonio, Texas, 78229
Japan4 sites
National Cancer Center Hospital East
Kashiwa-shi, 277-8577
Saitama Medical University International Medical Center
Saitama, 350-1298
National Cancer Center Hospital
Tokyo, 104-0045
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
Singapore3 sites
National University Health System (NUHS) - National University Cancer Institute Singapore (NCIS)
Singapore, 119228
National Cancer Centre Singapore
Singapore, 168583
Curie Oncology
Singapore, 217562
Australia2 sites
Linear Clinical Research
Nedlands, WA 6009
Royal North Shore Hospital Northern Sydney Cancer Centre
St Leonards, NSW 2065
About this study
Official 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
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.
Read the 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- ZW191
- Keywords
- Advanced or Metastatic Cancers, ADC, Folate alpha receptor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZW191Drug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| ZW191 | Experimental | Not described Receives: Drug: ZW191 |
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 ZW191
Measured: Up to 3 weeks
Incidence of adverse events (AEs; Parts 1 and 2)
Number of participants who experienced AEs, adverse events of special interest (AESIs), or serious adverse events (SAEs)
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 (8)
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
Clinical benefit rate (Parts 1 and 2)
Number of participants who achieved a best response of CR, PR, non-CR/non-progressive disease (PD), or stable disease (SD) lasting at least 180 days per 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 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
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 SD during treatment per RECIST v1.1
Measured: Up to approximately 2 years
Progression-free survival (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
Best overall response (BOR; Part 2)
Measured: Up to approximately 2 years
Serum or plasma concentration and PK parameters of ZW191 (Parts 1 and 2)
Maximum serum concentration and trough concentration of ZW191
Measured: Up to approximately 2 years
Incidence of anti-drug antibodies (ADAs; Parts 1 and 2)
Number of participants who develop ADAs
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start30 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zymeworks BC Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maggie Weinstein, MD, PhD, MPH, Study director, Zymeworks BC Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555744
- Sponsor's protocol ID
- ZWI-ZW191-101
- Other IDs
- 2024-512299-37-00
- Status last verified
- May 2026
- First submitted
- 13 Aug 2024
- Last updated
- 7 May 2026
- 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06555744
- Acronym / sponsor ID
- ZWI-ZW191-101
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced or Metastatic Cancers, ADC, Folate alpha receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Zymeworks BC Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Aug 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZW191 | Experimental | Drug: ZW191 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| ZW191Administered intravenously | Drug | ZW191 |
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 ZW191
Incidence of adverse events (AEs; Parts 1 and 2)
Time frame: Up to approximately 2 years
Number of participants who experienced AEs, adverse events of special interest (AESIs), or serious adverse events (SAEs)
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
8 secondary outcomes
Confirmed objective response rate (Part 1)
Time frame: Up to approximately 2 years
Clinical benefit rate (Parts 1 and 2)
Time frame: Up to approximately 2 years
Duration of response (DOR; Part 2)
Time frame: Up to approximately 2 years
Disease control rate (DCR; Part 2)
Time frame: Up to approximately 2 years
Progression-free survival (PFS; Part 2)
Time frame: Up to approximately 2 years
Best overall response (BOR; Part 2)
Time frame: Up to approximately 2 years
Serum or plasma concentration and PK parameters of ZW191 (Parts 1 and 2)
Time frame: Up to approximately 2 years
Incidence of anti-drug antibodies (ADAs; Parts 1 and 2)
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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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.
Maggie Weinstein, MD, PhD, MPH study director
Zymeworks BC Inc.
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZW191 in people with Advanced Solid Tumors, run by Zymeworks BC Inc. at 27 sites in 6 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in South Korea, Spain, United States, Japan, Singapore and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
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 4 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 7 May 2026.