A Study of ZW191 in Participants With 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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT06555744
Intervention or treatment
DRUG: ZW191
Conditions
- Advanced Solid Tumors
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Linear Clinical Research
Select from list below to view details:
Linear Clinical Research
Nedlands, Australia
Royal North Shore Hospital Northern Sydney Cancer Centre
St Leonards, Australia
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Who is running the clinical trial?
Zymeworks BC Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: ZW191
| Drug: ZW191 |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 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 | 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 | Up to approximately 2 years |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | Up to approximately 2 years |
| Best overall response (BOR; Part 2) | Not Specified | 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 | Up to approximately 2 years |
| Incidence of anti-drug antibodies (ADAs; Parts 1 and 2) | Number of participants who develop ADAs | Up to approximately 2 years |
References
Clinical Trials Gov: A Study of ZW191 in Participants With Solid TumorsOther trials to consider
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