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Clinical Trials in the USA / NCT06555744
Active, not recruiting Phase 1

A Study of ZW191 in Participants With Solid Tumors

NCT06555744 · tracked via the Priya Life Science USA tracker
Sponsor
Zymeworks BC Inc
Phase
Phase 1
Started
2024-10-30
Last updated
2026-05-07

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

ZW191

ZW191: Administered intravenously

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of dose-limiting toxicities (DLTs; Part 1) — 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) — 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) — 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) — 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

Trial sites (27)

FacilityCityRegionStatus
Yale University New Haven Connecticut
The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute Columbus Ohio
Stephenson Cancer Center Oklahoma City Oklahoma
NEXT Oncology San Antonio Texas
NEXT Virginia Fairfax Virginia
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
The Cancer Institute Hospital of JFCR Tokyo Japan
National University Health System (NUHS) - National University Cancer Institute Singapore (NCIS) Singapore Singapore
National Cancer Centre Singapore Singapore Singapore
Curie Oncology Singapore Singapore
National Cancer Center Goyang-si South Korea
Seoul National University Bundang Hospital Seongnam-si South Korea
Seoul National University Hospital Seoul South Korea
Severance Hospital, Yonsei University Health System Seoul South Korea
Asan Medical Center Seoul South Korea
Samsung Medical Center Seoul South Korea
Gangnam Severance Hospital Seoul South Korea
Hospital Universitari Vall d'Hebron Barcelona Spain
Hospital Universitario Reina Sofia Córdoba Spain
Clínica Universidad de Navarra Madrid Spain
NEXT Oncology Madrid Madrid Spain
Fundacion Instituto Valenciano de Oncologia (IVO) Valencia Spain
Hospital Clinico Universitario de Valencia Valencia Spain

More Zymeworks BC Inc. trials in the USA

A Study of ZW251 in Participants With Advanced Solid Tumors Recruiting

Other trials for the same condition

Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors Active, not recruiting
Study of GS-2426 in Participants With Advanced Solid Tumors Recruiting
Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment Recruiting
Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors Recruiting
A Study of BG-C477 in Participants With Advanced Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06555744 on ClinicalTrials.gov ↗ ← All trials in the USA