A Phase 1 Study for ZW191 in Participants with Solid Tumors

JRCT ID: jRCT2031240343

Registered date:18/09/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Ovarian cancer
Endometrial cancer
Non-small cell lung cancer

• Date of first enrollment: 10/10/2024
• Target sample size: 20
• Countries of recruitment: US,Japan,Korea,Japan,Singapore,Japan,Australia,Japan,Canada,Japan,Poland,Japan,Spain,Japan
• Study type: Interventional
• Intervention(s): ZW191 will be administered intravenously on Day 1 of each 21-day cycle (Q3W).

Outcome(s)

Primary Outcome

- Incidence of dose-limiting toxicities (DLTs) (Part 1)
- Incidence of adverse events (AEs) (Parts 1 and 2)
- Incidence of clinical laboratory abnormalities (Parts 1 and 2)
- Confirmed objective response rate (cORR) (Part 2)

Secondary Outcome

- Confirmed objective response rate (cORR) (Part 1)
- Clinical benefit rate (CBR) (Parts 1 and 2)
- Duration of response (DOR) (Part 2)
- Disease control rate (DCR) (Part 2)
- Progression-free survival (PFS) (Part 2)
- Best overall response (BOR) (Part 2)
- Serum or plasma concentration and PK parameters of ZW191 (Parts 1 and 2)
- Incidence of anti-drug antibodies (ADAs) (Parts 1 and 2)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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 (ADC) 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.

Related Information

• Primary Sponsor: Matsuda Rena
• Secondary ID(s): NCT06555744