臨床研究等提出・公開システム

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

A Phase 1 Study for ZW191 in Participants with Solid Tumors

Matsuda Rena

Syneos Health Japan K.K.

12F JP Tower, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo

ZWI-ZW191-101@synoshealth.com

Matsuda Rena

Syneos Health Japan K.K.

12F JP Tower, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo

+81-70-1506-0940

ZWI-ZW191-101@syneoshealth.com

Not Recruiting

Oct. 04, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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.

- 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.

Both

Ovarian cancer
Endometrial cancer
Non-small cell lung cancer

ZW191 is administrated by intravenous infusion once every 3 weeks.
Part 1: The starting dose of the investigational product in Dose Level 1of the Dose escalation will be 1.6 mg/kg, and subsequent doses may increase based on clinical data in Part 1. Part 2: Dose Optimization/Dose expansion will be initiated at dose levels (RDEs) based on the clinical data from Part 1. The RDE dose levels may vary across the tumor types in Cohorts 1, 2, and 3.

- Frequency and severity of DLTs (Part 1)
- Frequency and severity of AEs (Parts 1 and 2)
- Frequency of SAEs and deaths (Parts 1 and 2)
- Frequency and severity of clinical laboratory abnormalities (Parts 1 and 2)
- Frequency and severity of AESIs (Parts 1 and 2)
- Frequency of dose reductions of ZW191 (Parts 1 and 2)
- Confirmed objective response rate (cORR) (Part 2)

- Serum or plasma concentrations and PK parameters of ZW191 (Parts 1 and 2)
- Presence of ADAs to ZW191 during the study relative to the presence of ADAs at baseline (Parts 1 and 2)
- Best overall response (BOR) (Parts 1 and 2)
- Duration of response (DOR) (Parts 1 and 2)
- Disease control rate (DCR) (Parts 1 and 2)
- Progression-free survival (PFS) (Parts 1 and 2)
- Confirmed objective response rate (cORR) (Part 1)
- Clinical benefit rate (CBR) (Parts 1 and 2)
- Overall Survival (OS) (Parts 1 and 2)

+81-42-984-4523

Aug. 28, 2024

No

US/Korea/Singapore/Australia/Spain