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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, estimated as an average of 47 months for reporting.

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 more

Secondary outcome measures

Phase 1 and 2: Immunogenicity of PBI-410

Phase 1: Duration of Response (DoR)

Phase 1: ORR

+3 more

Trial 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

0 / 9Eligibility criteria met

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

~147 spots leftby Feb 2028

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