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Monoclonal Antibody
PTX-35 for Solid Tumors
Phase 1
Waitlist Available
Led By Anthony W Tolcher, MD
Research Sponsored by Pelican Therapeutics, 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 up to 12 months
Awards & highlights
Study Summary
This trial is testing a new antibody drug in patients with cancer that has spread and is no longer responding to standard treatments. The goal is to see if the new drug is safe and what the best dose is.
Eligible Conditions
- Advanced Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Subjects With Any Treatment-emergent Adverse Events (TEAEs) During the Trial
Secondary outcome measures
Determine PK area under curve up to the last measurable concentration (AUClast)
Determine PK maximum concentration (Cmax)
Determine PK terminal elimination half-life (T1/2λz)
+3 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: PTX-35 Dose Level 6Experimental Treatment1 Intervention
Dose Level 6: PTX-35 3.0 mg/kg
Group II: PTX-35 Dose Level 5Experimental Treatment1 Intervention
Dose Level 5: PTX-35 1.0 mg/kg
Group III: PTX-35 Dose Level 4Experimental Treatment1 Intervention
Dose Level 4: PTX-35 0.30 mg/kg
Group IV: PTX-35 Dose Level 3Experimental Treatment1 Intervention
Dose Level 3: PTX-35 0.10 mg/kg
Group V: PTX-35 Dose Level 2Experimental Treatment1 Intervention
Dose Level 2: PTX-35 0.03 mg/kg
Group VI: PTX-35 Dose Level 1Experimental Treatment1 Intervention
Dose Level 1: PTX-35 0.01 mg/kg
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Who is running the clinical trial?
Pelican Therapeutics, Inc.Lead Sponsor
Anthony W Tolcher, MDPrincipal InvestigatorNext Oncology
1 Previous Clinical Trials
29 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we still taking patients for this experiment?
"While this particular study isn't looking for any more participants at the moment, that may change in the future. According to the information found on clinicaltrials.gov, this trial was posted on June 4th, 2020 and was last updated on October 3rd, 2020. There are currently 2564 other trials actively recruiting patients."
Answered by AI
When will PTX-35 be available for general use?
"PTX-35 received a safety score of 1 because, as a Phase 1 trial, there is minimal clinical data to support its efficacy and safety."
Answered by AI
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