assignment
Recruiting

A Phase 1 Study of ZW251 in Participants with Advanced Solid Tumors

Trial ID
2025-523088-39-00
Protocol
ZWI-ZW251-101

Trial statistics

location_city
8
research sites
public
3
countries
person_search
12
investigators

Objectives

The primary objective of this Phase 1 study is to evaluate the safety and tolerability of ZW251 in participants diagnosed with advanced solid tumors. Establishing the safety profile and determining the maximum tolerated dose is clinically essential for the development of novel therapeutic agents in oncology.

Participants

The study population consists of 69 patients diagnosed with advanced solid tumors. The cohort includes both male and female participants. Based on the provided age range codes, the subjects fall within specific developmental age categories. The study population is characterized as vulnerable.

Plans and Procedures

This Phase 1 study evaluates the safety and pharmacokinetics of ZW251 in participants diagnosed with advanced solid tumors. The research methodology involves a controlled clinical design to assess the investigational product. The study sequence begins with a screening visit to determine eligibility based on specific inclusion and exclusion criteria. Following successful screening, participants proceed through scheduled follow-up visits to monitor clinical responses and safety parameters. The protocol concludes with an end-of-study visit. The total duration of participant involvement is determined by the established treatment cycles and safety monitoring requirements. Early termination from the study may occur if predefined safety criteria are met or if the participant's clinical condition necessitates discontinuation.

Treatment

Please provide the source data containing the names, forms, dosages, and administration details of the medications. Without the source information, a description of the treatments cannot be generated.

Efficacy

The assessment of efficacy in this phase 1 clinical trial for advanced solid tumors is not specified.

Trial Status by Country

Country Status Start of Recruitment Planned Patients
Ireland IrelandRecruiting30 Jan 20263
Portugal PortugalRecruiting30 Jan 20266
Spain SpainRecruiting30 Jan 202622

Sites & Investigators