Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06555744

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Advanced Solid Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Linear Clinical Research, Nedlands, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZW191

Drug

Administered intravenously

Primary outcomes

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

    Time frame: Up to 3 weeks

    Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to ZW191

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

    Time frame: Up to approximately 2 years

    Number of participants who experienced AEs, adverse events of special interest (AESIs), or serious adverse events (SAEs)

  3. Incidence of clinical laboratory abnormalities (Parts 1 and 2)

    Time frame: 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

  4. Confirmed objective response rate (Part 2)

    Time frame: 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

Secondary outcomes

  1. Confirmed objective response rate (Part 1)

    Time frame: Up to approximately 2 years

    Number of participants who achieved a best overall response of either confirmed CR or PR during treatment according to RECIST v1.1

  2. Clinical benefit rate (Parts 1 and 2)

    Time frame: Up to approximately 2 years

    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

  3. Duration of response (DOR; Part 2)

    Time frame: Up to approximately 2 years

    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

  4. Disease control rate (DCR; Part 2)

    Time frame: Up to approximately 2 years

    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

  5. Progression-free survival (PFS; Part 2)

    Time frame: Up to approximately 2 years

    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

  6. Best overall response (BOR; Part 2)

    Time frame: Up to approximately 2 years

  7. Serum or plasma concentration and PK parameters of ZW191 (Parts 1 and 2)

    Time frame: Up to approximately 2 years

    Maximum serum concentration and trough concentration of ZW191

  8. Incidence of anti-drug antibodies (ADAs; Parts 1 and 2)

    Time frame: Up to approximately 2 years

    Number of participants who develop ADAs

Sponsors and collaborators

Lead sponsor

Zymeworks BC Inc.

Industry

Registry information

Official study title

A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of a Folate Receptor Alpha Antibody Drug Conjugate, ZW191, in Participants With Advanced Solid Tumors

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 15, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.