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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
Study Summary
This trial aims to find the best dose to treat cancer in people with tumors that haven't responded to treatment.
Who is the study for?
Adults over 18 with certain types of advanced solid tumors, like lung or breast cancer, who've seen their disease get worse after treatment can join. They should be fairly active (ECOG 0-1), have a life expectancy over 3 months, and provide tumor samples. People with brain metastases needing high-dose steroids or recent major surgery can't participate.Check my eligibility
What is being tested?
The trial is testing different doses of PYX-201 to find the safest and most effective amount for treating various advanced solid tumors in patients whose previous treatments didn't work.See study design
What are the potential side effects?
Specific side effects of PYX-201 aren't listed here, but common ones for cancer drugs include nausea, fatigue, risk of infection, allergic reactions, and organ inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants who Experience a Dose-limiting Toxicity (DLT)
Number of Participants who Experience an Adverse Event (AE)
Secondary outcome measures
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum
Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-201 Antibody-drug Conjugate, Total Antibody, Free Payload and Associated Metabolites in Serum
+11 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PYX-201 Dose EscalationExperimental Treatment1 Intervention
Participants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of PYX-201. Intra-participant dose escalation may be considered for participants who have adequately tolerated therapy.
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Who is running the clinical trial?
Pyxis Oncology, IncLead Sponsor
2 Previous Clinical Trials
77 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active infection needing treatment as I start PYX-201.I had cancer before, but it's either completely treated or in remission for over 2 years.I have at least one tumor that can be measured or I have breast cancer that has spread to bones only.I am fully active or can carry out light work.I have not had major surgery in the last 4 weeks.I have had a solid organ or bone marrow transplant.I have a confirmed diagnosis of a specific type of cancer such as lung, breast, ovarian, or another listed type.I am an adult over 18 and not pregnant or breastfeeding if female.I need more than 10 mg/day of prednisolone for my brain metastases.My cancer has grown or spread after my last treatment.My clinical site can provide fresh or archived tumor samples for at least 14 slides.
Research Study Groups:
This trial has the following groups:- Group 1: PYX-201 Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please detail the safety measures associated with PYX-201 Dose Escalation?
"Our team at Power has assigned a score of 1 to PYX-201 Dose Escalation, as this is in its early Phase 1 trial and there is limited evidence for safety and efficacy."
Answered by AI
How many individuals are currently enrolled in this research study?
"Affirmative. According to clinicaltrials.gov, the trial was posted on the 1st of March 2023 and underwent its last edit on February 27th of the same year. There are currently 45 vacancies across two medical sites that require filling."
Answered by AI
Are there any available positions for individuals to participate in this clinical experiment?
"Affirmative. The clinicaltrials.gov website reveals that this medical study, posted on March 1st 2023, is actively seeking participants. 45 individuals are needed at 2 separate sites for the trial to be completed successfully."
Answered by AI
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