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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
No Placebo-Only Group
Summary
This trial is testing PUR001, a new medicine that targets a protein on cancer cells. It is aimed at adults with advanced cancers that are difficult to treat. The medicine works by blocking a protein to stop the cancer from growing and spreading.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD), if reached
Secondary study objectives
Area under the concentration time curve (AUC 0-last)
Disease Control Rate (DCR)
Duration of Response (DOR)
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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.
36 Previous Clinical Trials
87,636 Total Patients Enrolled
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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.
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