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Proton Beam Therapy
PBI-410 for Advanced Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Pyramid Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Participants have adequate hematologic, renal, liver, and coagulation function as defined by specific criteria
Must not have
Any major surgical procedure within 6 weeks prior to C1D1
Has a medical history of interstitial lung disease or current interstitial lung disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, estimated as an average of 47 months
Awards & highlights
Summary
This trial is testing a new drug called PBI-410 in people who have advanced solid tumors that have been previously treated.
Who is the study for?
This trial is for adults (18+) with advanced solid tumors that can't be surgically removed or cured and have failed standard treatments. They should have acceptable liver function, no serious blood disorders, and a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory.
What is being tested?
The study tests PBI-410 on participants with previously treated advanced solid tumors. It's an open-label trial, meaning both the researchers and participants know what treatment is being given, to evaluate its safety and effectiveness.
What are the potential side effects?
Specific side effects of PBI-410 aren't listed here, but common ones for cancer drugs include fatigue, nausea, diarrhea, blood count changes increasing infection risk; liver enzyme elevations could indicate potential liver damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My blood, kidney, liver, and clotting tests are within normal ranges.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had major surgery in the last 6 weeks.
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I have a history of or currently have interstitial lung disease.
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I need extra oxygen to do my daily activities.
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I am not pregnant or breastfeeding.
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I have a serious eye condition affecting my cornea.
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I've had severe allergic reactions to certain medications.
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I have been treated with Trop-2 targeted therapy before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, estimated as an average of 47 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, estimated as an average of 47 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Number of patients with adverse events (AEs)
Phase 1: Recommended dose for expansion (RDE) and maximum tolerated dose (MTD)
Phase 2: Duration of Response (DoR) for PB-410 monotherapy only
+2 moreSecondary outcome measures
Phase 1 and 2: Immunogenicity of PBI-410
Phase 1: Duration of Response (DoR)
Phase 1: ORR
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: PBI-410 in combination with Cemiplimab dose escalationExperimental Treatment2 Interventions
Group II: PBI-400 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340
Find a Location
Who is running the clinical trial?
Pyramid BiosciencesLead Sponsor
7 Previous Clinical Trials
167 Total Patients Enrolled
Biohaven Therapeutics Ltd.Lead Sponsor
10 Previous Clinical Trials
3,932 Total Patients Enrolled
Chief Medical OfficerStudy DirectorBiohaven Pharmaceuticals, Inc.
124 Previous Clinical Trials
21,611 Total Patients Enrolled
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