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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 day 1 to day 28
Awards & highlights
Study Summary
This trial tests what dose of a drug is best for treating cancer in people whose cancer has returned or is not responding to treatment.
Who is the study for?
This trial is for adults with certain solid tumors that have stopped responding to standard treatments. They must have a measurable tumor, a life expectancy over 3 months, and be in good physical condition (ECOG 0 or 1). People can't join if they need high-dose steroids for brain metastases, haven't recovered from previous treatments' side effects, had major surgery recently, got live vaccines within the last month, or have other active cancers.Check my eligibility
What is being tested?
The study is testing PYX-106 to find the safest and most effective dose for treating various advanced solid tumors that no longer respond to conventional therapies. It's an early-phase trial primarily focused on dosage rather than comparing it with other treatments.See study design
What are the potential side effects?
Specific side effects of PYX-106 are not listed here but may include typical reactions seen with cancer drugs such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems. Side effects depend on how well individuals tolerate the drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 28
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 Time Concentration Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-106
Area Under the Time Concentration Curve from Time 0 to the End of the Dosing Interval (AUCtau) of PYX-106
Area Under the Time Concentration Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-106
+9 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PYX-106 Dose EscalationExperimental Treatment1 Intervention
Participants will receive escalating doses of PYX-106 to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of PYX-106, and to determine the recommended dose(s).
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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 have not received a live vaccine in the last 28 days.I have moderate to severe nerve damage in my hands or feet.I have had cancer before, but it was either treated successfully, is in remission for over 2 years, or is not expected to affect my survival within the next 5 years.I am fully active or can carry out light work.I need more than 10 mg/day of prednisolone for my brain metastases.I have not had major surgery in the last 4 weeks.I still have side effects from cancer treatment, except for hair loss or hormone issues.My cancer has returned or worsened despite treatment.I had radiation therapy for symptom relief within the last 14 days.My cancer has grown or spread after my last treatment, confirmed by scans.My doctor can provide tissue samples from my tumor for the study.My cancer has worsened despite treatment, or there's no suitable standard treatment for me.
Research Study Groups:
This trial has the following groups:- Group 1: PYX-106 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.
Are there any safety concerns associated with escalating the dosage of PYX-106?
"Due to the lack of clinical data behind PYX-106 Dose Escalation, our team at Power assigned it a score of 1 for safety. This is mainly because this Phase 1 trial has only limited evidence in terms of efficacy and safety."
Answered by AI
Are there still openings for people to participate in this clinical investigation?
"This medical trial is actively seeking participants, as evidenced by details hosted on clinicaltrials.gov. The study was initially announced on February 1st 2023 and had its most recent update occur in late January of the same year."
Answered by AI
What is the current capacity of this research endeavor?
"Affirmative. Clinicaltrials.gov has information that reveals this clinical trial is presently on the hunt for prospective participants; it was originally posted to the website on February 1st 2023 and its last update occurred at end of January in the same year. 45 people are required from 2 different medical facilities."
Answered by AI
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