A Study of PYX-201 in Advanced Solid Tumors
This study is testing a new drug called PYX-201, which is an antibody-drug conjugate (a targeted therapy that delivers a powerful drug directly to cancer cells). It's for adults aged 18 and older with advanced solid tumors, including certain types of breast cancer, head and neck cancer, and other solid tumors that have progressed after previous treatments. The main goals are to find the safest and most effective dose of PYX-201 and to see how many participants respond to the treatment. We don't yet know the current recruitment status for this study.
- Study design
- This study is interventional and plans to enroll 330 participants. It is designed to evaluate the safety and effectiveness of PYX-201 as a single agent.
- What's involved
- Participants will be monitored for side effects for up to approximately 3 years. The study will also measure how well the treatment works for up to approximately 2 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for safety and tolerability for up to approximately 3 years. Objective response to treatment will be measured for up to approximately 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of PYX-201 in Advanced Solid Tumors
At a glance
Conditions
Where it's being run
29 sites across 21 statesWho to contact
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What this trial measures
- Number of Participants who Experience a Dose-limiting Toxicity (DLT) in Dose EscalationDay 1 to Day 21
DLT is defined as (1) an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs after the treatment with PYX-201 and (2) meets any of the predefined criteria outlined in the protocol.
- Safety and Tolerability as assessed by adverse event monitoring for participants in Dose EscalationUp to approximately 3 years
Adverse Events as characterized by type, incidence, seriousness, relationship to study treatment, timing, and severity (as graded by NCI-CTCAE Version 5.0). Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs.
- Objective Response Rate (ORR) observed in participants in Dose ExpansionUp to approximately 2 years