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
Phase 1 trial of ZW191 for advanced solid tumors
Plain English Summary
A Study of ZW191 in Participants With Solid Tumors is a Phase 1 clinical trial sponsored by Zymeworks BC Inc. studying Advanced Solid Tumors. This study tests a new drug called ZW191, which is an antibody drug conjugate, to see if it's safe and effective in treating advanced cancers. It is for adults with advanced solid tumors, including ovarian, endometrial, and non-small cell lung cancers, whose disease has spread or cannot be removed by surgery. Participants will receive ZW191 intravenously, and will be closely monitored for side effects and tumor response. Alternative treatments may include chemotherapy, targeted therapy, or immunotherapy, depending on the specific cancer type and previous treatments. The trial aims to enroll 145 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with pathologically confirmed advanced, unresectable, recurrent, or metastatic solid tumors. Patients must have measurable disease and a good performance status (ECOG 0 or 1). Adequate heart and organ function is required. Individuals who have received prior treatment with a Topoisomerase I inhibitor antibody drug conjugate, or have active uncontrolled infections, or other progressing malignancies will not be eligible. This trial is studying Advanced Solid Tumors, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcomes measure how often dose-limiting toxicities and adverse events occur, and how well the drug shrinks tumors, which helps determine if the drug is safe and shows early signs of worki The specific primary outcome measures are: Incidence of dose-limiting toxicities (DLTs; Part 1) (Up to 3 weeks); Incidence of adverse events (AEs; Parts 1 and 2) (Up to approximately 2 years); Incidence of clinical laboratory abnormalities (Parts 1 and 2) (Up to approximately 2 years); Confirmed objective response rate (Part 2) (Up to approximately 2 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial is important because it explores a new treatment approach for patients with advanced cancers who have limited options, aiming to fill a gap in current therapies. This research targets Advanced Solid Tumors, where improved treatment options are needed.
Investor Insight
This Phase 1 trial of ZW191, targeting Folate Receptor Alpha, represents an early-stage investment in a potentially novel antibody drug conjugate for a broad range of advanced solid tumors, with a com Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of ZW191, and how it compares to other available treatments. Participation involves regular clinic visits for drug infusions, blood tests, scans, and monitoring for side effects. The study will last for approximately 2 years, with specific treatment cycles and follow-up periods. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 145 participants
Interventions
- DRUG: ZW191 — Administered intravenously
Primary Outcomes
- Incidence of dose-limiting toxicities (DLTs; Part 1) (Up to 3 weeks)
- Incidence of adverse events (AEs; Parts 1 and 2) (Up to approximately 2 years)
- Incidence of clinical laboratory abnormalities (Parts 1 and 2) (Up to approximately 2 years)
- Confirmed objective response rate (Part 2) (Up to approximately 2 years)
Secondary Outcomes
- Confirmed objective response rate (Part 1) (Up to approximately 2 years)
- Clinical benefit rate (Parts 1 and 2) (Up to approximately 2 years)
- Duration of response (DOR; Part 2) (Up to approximately 2 years)
- Disease control rate (DCR; Part 2) (Up to approximately 2 years)
- Progression-free survival (PFS; Part 2) (Up to approximately 2 years)
Full 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.
Trial Locations
- Yale University, New Haven, Connecticut, United States
- The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, Ohio, United States
- Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
- NEXT Oncology, San Antonio, Texas, United States
- NEXT Virginia, Fairfax, Virginia, United States
- Linear Clinical Research, Nedlands, Australia
- Royal North Shore Hospital Northern Sydney Cancer Centre, St Leonards, Australia
- National Cancer Center Hospital East, Kashiwa-shi, Japan
- Saitama Medical University International Medical Center, Saitama, Japan
- National Cancer Center Hospital, Tokyo, Japan
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06555744?
NCT06555744 is a Phase 1 INTERVENTIONAL study titled "A Study of ZW191 in Participants With Solid Tumors." It is currently recruiting and is sponsored by Zymeworks BC Inc.. The trial targets enrollment of 145 participants.
What conditions does NCT06555744 study?
This trial investigates treatments for Advanced Solid Tumors. The primary condition under study is Advanced Solid Tumors.
What treatments are being tested in NCT06555744?
The interventions being studied include: ZW191 (DRUG). Administered intravenously
What does Phase 1 mean for NCT06555744?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT06555744?
This trial is currently "Recruiting." It started on 2024-10-30. The estimated completion date is 2027-01.
Who is sponsoring NCT06555744?
NCT06555744 is sponsored by Zymeworks BC Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06555744?
The trial aims to enroll 145 participants. The trial is currently recruiting and accepting new participants.
How is NCT06555744 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT06555744?
The primary outcome measures are: Incidence of dose-limiting toxicities (DLTs; Part 1) (Up to 3 weeks); Incidence of adverse events (AEs; Parts 1 and 2) (Up to approximately 2 years); Incidence of clinical laboratory abnormalities (Parts 1 and 2) (Up to approximately 2 years); Confirmed objective response rate (Part 2) (Up to approximately 2 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06555744 being conducted?
This trial is being conducted at 20 sites, including New Haven, Connecticut; Columbus, Ohio; Oklahoma City, Oklahoma; San Antonio, Texas and 16 more sites (United States, Australia, Japan).
Where can I find official information about NCT06555744?
The official record for NCT06555744 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06555744. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06555744 testing in simple terms?
This study tests a new drug called ZW191, which is an antibody drug conjugate, to see if it's safe and effective in treating advanced cancers. It is for adults with advanced solid tumors, including ovarian, endometrial, and non-small cell lung cancers, whose disease has spread or cannot be removed by surgery.
Why is this trial significant?
This trial is important because it explores a new treatment approach for patients with advanced cancers who have limited options, aiming to fill a gap in current therapies.
What are the potential risks of participating in NCT06555744?
Common side effects may include nausea, fatigue, and changes in blood counts. More serious risks can include severe allergic reactions, damage to organs like the liver or kidneys, and effects on the heart. Specific risks related to ZW191, such as myelosuppression (low blood cell counts) and peripheral neuropathy, will be closely monitored. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06555744?
Ask your doctor about the potential benefits and risks of ZW191, and how it compares to other available treatments. Participation involves regular clinic visits for drug infusions, blood tests, scans, and monitoring for side effects. The study will last for approximately 2 years, with specific treatment cycles and follow-up periods. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06555744 signal from an investment perspective?
This Phase 1 trial of ZW191, targeting Folate Receptor Alpha, represents an early-stage investment in a potentially novel antibody drug conjugate for a broad range of advanced solid tumors, with a com This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive ZW191 intravenously, and will be closely monitored for side effects and tumor response. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Advanced Solid Tumors Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.