A Study of ZW171 in Participants With Advanced or Metastatic Mesothelin-expressing Cancers

NCT06523803 | Terminated Phase 1 FDA Drug

• 2 other identifiers: ZWI-ZW171-1012024-511119-11
• Study Type: interventional
• Target: 32
• Locations: 4 countries
• Sites: 15

Brief Summary

This study is being done to find out if ZW171 is safe and can treat participants with advanced (locally advanced \[inoperable\] and/or metastatic) mesothelin-expressing cancers.

Conditions

Mesothelin-expressing Advanced Cancers

Keywords

Advanced or Metastatic Cancers; ADC; Antibody drug conjugate

Outcome Measures

Primary Outcomes (6)

• 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 ZW171

  Up to 3 weeks

• Incidence of adverse events (AEs; Parts 1 and 2)

  Number of participants who experienced AEs or serious adverse events (SAEs)

  Up to approximately 2 years

• Incidence of cytokine release syndrome (CRS; Parts 1 and 2)

  Number of participants who experienced CRS

  Up to approximately 2 years

• Incidence of neurotoxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS; Parts 1 and 2)

  Number of participants who experienced neurotoxicity, including ICANS

  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 (7)

• Confirmed objective response rate (Part 1)

  Up to approximately 2 years

• Duration of response (DOR; Part 2)

  Up to approximately 2 years

• Progression-free survival (PFS), including 1-year PFS (Part 2)

  Up to approximately 2 years

• Disease control rate (DCR; Part 2)

  Up to approximately 2 years

• Overall survival (OS), including 1-year OS (Part 2)

  Up to approximately 2 years

Study Arms (1)

ZW171

EXPERIMENTAL

Drug: ZW171

Interventions

ZW171 DRUG

Administered per protocol requirements

ZW171

Eligibility Criteria

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

You may qualify if:

• Pathologically confirmed diagnosis of cancers with evidence of locally advanced (unresectable) and/or metastatic disease. Cancers that are refractory to all available standard of care (SOC) treatment, cancers for which no SOC treatment is available, or the participant cannot tolerate or refuses SOC therapy.
• An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• Adequate cardiac left ventricular function, as defined by left ventricular ejection fraction ≥ 50% as determined by either echocardiogram or multigated acquisition scan.
• Adequate organ function.

You may not qualify if:

• Known additional malignancy that is progressing or that has required active treatment.
• Undergone prior allogenic tissue (e.g., hematopoietic stem cell) or solid organ transplantation within the last 5 years.
• Ongoing, clinically significant toxicity (Grade ≥ 2) associated with prior cancer therapies, with the exception of alopecia.
• Advanced/metastatic, symptomatic, visceral spread, at risk of life-threatening complications in the short-term (including participants with massive uncontrolled effusion \[pleural, pericardial\], pulmonary lymphangitis, active unresolved bowel obstruction, massive ascites \[requiring paracentesis \>2 times within 2 weeks prior to the first dose\], and over 50% liver involvement).
• Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of participants with Gilbert's Syndrome, asymptomatic gall stones, liver metastases, or stable chronic liver disease per investigator assessment).
• Active or recurrent clinically significant autoimmune disease requiring systemic high-dose corticosteroids or immunosuppressive drugs.

Sponsors & Collaborators

• Zymeworks BC Inc.: lead

Study Sites (15)

University of Southern California - Norris Comprehensive Cancer Center

Los Angeles, California, 90089, United States

Location

University of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Icahn School of Medicine at Mount Sinai (ISMMS) - The Blavatnik Family-Chelsea Medical Center

New York, New York, 10011, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Universitaetsklinikum Dresden

Dresden, 01307, Germany

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Yonsei University Health System - Severance Hospital

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea, Seoul St. Marys Hospital

Seoul, South Korea

Location

Guys and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Royal Marsden Hospital

Sutton, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Pranshul Chauhan, MSc, MB, BCh, BAO

  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: July 22, 2024
• First Posted: July 26, 2024
• Study Start: September 30, 2024
• Primary Completion: September 30, 2025
• Study Completion: October 1, 2025
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4); DE (1); US (7); GB (3)