A Study of ZW191 in Participants With Solid Tumors

NCT06555744 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: ZWI-ZW191-1012024-512299-37-00
• Study Type: interventional
• Target: 145
• Locations: 6 countries
• Sites: 27

Brief 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.

Conditions

Advanced Solid Tumors

Keywords

Advanced or Metastatic Cancers; ADC; Folate alpha receptor

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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

Study Arms (1)

ZW191

EXPERIMENTAL

Drug: ZW191

Interventions

ZW191 DRUG

Administered intravenously

ZW191

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zymeworks BC Inc.: lead

Study Sites (27)

Yale University

New Haven, Connecticut, 06510, United States

Location

The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

Columbus, Ohio, 43210, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

NEXT Virginia

Fairfax, Virginia, 22031, United States

Location

Linear Clinical Research

Nedlands, WA 6009, Australia

Location

Royal North Shore Hospital Northern Sydney Cancer Centre

St Leonards, NSW 2065, Australia

Location

National Cancer Center Hospital East

Kashiwa-shi, 277-8577, Japan

Location

Saitama Medical University International Medical Center

Saitama, 350-1298, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

Location

National University Health System (NUHS) - National University Cancer Institute Singapore (NCIS)

Singapore, 119228, Singapore

Location

National Cancer Centre Singapore

Singapore, 168583, Singapore

Location

Curie Oncology

Singapore, 217562, Singapore

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Gangnam Severance Hospital

Seoul, 6273, South Korea

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Clínica Universidad de Navarra

Madrid, 28027, Spain

Location

NEXT Oncology Madrid

Madrid, 28223, Spain

Location

Fundacion Instituto Valenciano de Oncologia (IVO)

Valencia, 46009, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Maggie Weinstein, MD, PhD, MPH

  Zymeworks BC Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4); US (5); SG (3); ES (6); KR (7); AU (2)