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
- Sponsor
- Pyxis Oncology Inc.
Trial statistics
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
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 | Recruiting | 06 Feb 2026 | 9 |
Poland | Not Recruiting | 06 Feb 2026 | 2 |
Spain | Recruiting | 06 Feb 2026 | 10 |



