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Monoclonal Antibodies
PUR001 for Solid Tumors
Phase 1
Recruiting
Research Sponsored by Purinomia Biotech, Inc.
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 1-1.5 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective. The drug will be given to a small group of people to see what effects, if any, it has.
Eligible Conditions
- Advanced Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-1.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD), if reached
Secondary outcome measures
Area under the concentration time curve (AUC 0-last)
Disease Control Rate (DCR)
Duration of Response (DOR)
+9 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Monotherapy classic "3+3" design dose escalation and expansionExperimental Treatment1 Intervention
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Who is running the clinical trial?
Purinomia Biotech, Inc.Lead Sponsor
Clinical DevelopmentStudy DirectorPurinomia Biotech, Inc.
35 Previous Clinical Trials
88,828 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with advanced or metastatic solid tumors and have already tried at least one type of chemotherapy that did not work.You are currently taking high doses of blood-thinning medications like warfarin sodium (Coumadin®) or similar drugs.You have experienced unstable chest pain within the past 3 months before starting the study drug.You have had a severe allergic reaction (grade 3 or higher) to biological medications that cannot be controlled with steroids.You have another type of cancer that is getting worse or needs treatment, except for certain types that are not aggressive and have been treated successfully before.You have a heart condition or other serious health issues that could affect your participation in the study.You have cancer that has spread to your brain or central nervous system, and it is either untreated or getting worse. However, if you have already received treatment for brain metastases and have not needed corticosteroids for 28 days, you can still participate.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy classic "3+3" design dose escalation and expansion
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.
Does the study continue to accept participants?
"As indicated on clinicaltrials.gov, this research project is no longer recruiting participants. Initially posted in March 9th 2022 and last updated a few days before that, its closure has opened the doors for 2502 other experiments actively searching for candidates at present."
Answered by AI
What assessments have been made to ensure the safety of PUR001 for individuals undergoing treatment?
"PUR001 has only been assessed in a Phase 1 trial, therefore Power's team assigned it with the lowest safety score of 1. This is due to its lack of data regarding efficacy and safety."
Answered by AI
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