assignment
Recruiting

A Phase 1/2 Clinical Evaluation of PYX-201 and Pembrolizumab in Patients with Advanced Solid Tumors

Trial ID
2025-521828-30-00
Protocol
PYX-201-102

Trial statistics

location_city
8
research sites
public
3
countries
medical_information
1
disease
person_search
12
investigators

Diseases & Conditions

Objectives

The primary objective of this phase 1/2 study is to evaluate the safety and efficacy of PYX-201 in combination with pembrolizumab in patients with advanced solid tumors. This investigation is clinically relevant for determining the potential therapeutic benefit and tolerable dosing regimens of this combination approach in oncology.

Participants

The clinical trial involves a total of 79 patients. The study population consists of both male and female individuals. Participants are characterized by the presence of advanced solid tumors. The age distribution of the cohort corresponds to age groups 3 and 4. The population includes vulnerable individuals.

Plans and Procedures

This Phase 1/2 clinical trial evaluates the efficacy and safety of PYX-201 in combination with pembrolizumab for the treatment of advanced solid tumors. The study utilizes a randomized, double-blind, controlled design. The research process begins with a screening visit to determine eligibility. Following screening, participants proceed through scheduled follow-up visits to monitor clinical progress and safety parameters. The sequence concludes with an end-of-study visit. The total duration of participant involvement is determined by individual clinical response and protocol requirements. Early termination from the study may occur based on specific clinical criteria or safety concerns.

Treatment

Please provide the source data containing the names, dosages, routes of administration, and other details of the medications to be described. Once the source information is provided, the description will be generated according to your specific formatting and linguistic requirements.

Efficacy

The assessment of efficacy in the context of advanced solid tumors is not specified in the provided documentation.

Trial Status by Country

Country Status Start of Recruitment Planned Patients
France FranceRecruiting06 Feb 20269
Poland PolandNot Recruiting06 Feb 20262
Spain SpainRecruiting06 Feb 202610

Sites & Investigators

Conditions Studied in This Trial