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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-512299-37-00 | EU Trial (CTIS) Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZW191 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZW191 | Drug | Administered intravenously |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maggie Weinstein, MD, PhD, MPH | Zymeworks BC Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06510 | United States | ||
| The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute |
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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) | 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 |
| Columbus |
| Ohio |
| 43210 |
| United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| NEXT Oncology | San Antonio | Texas | 78229 | United States |
| NEXT Virginia | Fairfax | Virginia | 22031 | United States |
| Linear Clinical Research | Nedlands | WA 6009 | Australia |
| Royal North Shore Hospital Northern Sydney Cancer Centre | St Leonards | NSW 2065 | Australia |
| National Cancer Center Hospital East | Kashiwa-shi | 277-8577 | Japan |
| Saitama Medical University International Medical Center | Saitama | 350-1298 | Japan |
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135-8550 | Japan |
| National University Health System (NUHS) - National University Cancer Institute Singapore (NCIS) | Singapore | 119228 | Singapore |
| National Cancer Centre Singapore | Singapore | 168583 | Singapore |
| Curie Oncology | Singapore | 217562 | Singapore |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Gangnam Severance Hospital | Seoul | 6273 | South Korea |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Clínica Universidad de Navarra | Madrid | 28027 | Spain |
| NEXT Oncology Madrid | Madrid | 28223 | Spain |
| Fundacion Instituto Valenciano de Oncologia (IVO) | Valencia | 46009 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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