Clinical trial NCT06555744: A Study of ZW191 in Participants With Solid Tumors
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Advanced or Metastatic Cancers
ADC
Folate alpha receptor
Lead sponsor: Zymeworks BC Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-15
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: Incidence of dose-limiting toxicities (DLTs; Part 1)
timeFrame: Up to 3 weeks
measure: Incidence of adverse events (AEs; Parts 1 and 2)
timeFrame: Up to approximately 2 years
measure: Incidence of clinical laboratory abnormalities (Parts 1 and 2)
timeFrame: Up to approximately 2 years
measure: Confirmed objective response rate (Part 2)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Confirmed objective response rate (Part 1)
timeFrame: Up to approximately 2 years
measure: Clinical benefit rate (Parts 1 and 2)
timeFrame: Up to approximately 2 years
measure: Duration of response (DOR; Part 2)
timeFrame: Up to approximately 2 years
measure: Disease control rate (DCR; Part 2)
timeFrame: Up to approximately 2 years
measure: Progression-free survival (PFS; Part 2)
timeFrame: Up to approximately 2 years
measure: Best overall response (BOR; Part 2)
timeFrame: Up to approximately 2 years
measure: Serum or plasma concentration and PK parameters of ZW191 (Parts 1 and 2)
timeFrame: Up to approximately 2 years
measure: Incidence of anti-drug antibodies (ADAs; Parts 1 and 2)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Columbus
country: United States
facility: The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
city: Fairfax
country: United States
facility: NEXT Virginia
state: Virginia
city: Nedlands
country: Australia
facility: Linear Clinical Research
city: St Leonards
country: Australia
facility: Royal North Shore Hospital Northern Sydney Cancer Centre
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
city: Saitama
country: Japan
facility: Saitama Medical University International Medical Center
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Singapore
country: Singapore
facility: National University Health System (NUHS) - National University Cancer Institute Singapore (NCIS)
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
affiliation: Zymeworks BC Inc.
name: Akira Kojima, MD
role: STUDY_DIRECTOR
References: