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Virus Therapy
PBI-200 for Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by Pyramid Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has one of the following solid tumors which has progressed on or following at least one systemic therapy regimen administered for advanced or metastatic disease or for which no approved therapy exists: NTRK-fusion-positive, locally advanced (i.e., not amenable to surgical resection) or metastatic solid tumor (Note: Subjects with any grade of malignant glioma previously treated with systemic therapy are eligible). Phase 1: NTRK-gene amplified, locally advanced or metastatic solid tumor, EWSR1-WT1-positive DSRCTs. Subjects with NTRK-fusion-positive solid tumors other than primary brain tumors must have previously received treatment with a TRK inhibitor, unless the subject does not have access to TRK-inhibitor therapy (e.g., no TRK inhibitor is marketed and available to the subject in the subject's country) or the subject has declined treatment with available marketed TRK inhibitors. Subjects with NTRK-gene amplified solid tumors, primary brain tumors or EWSR1-WT1-positive DSRCTs may have received prior treatment with a TRK inhibitor but this is not required. Phase 2: Has measurable disease by RECIST v1.1 for subjects with non-brain primary tumors or RANO criteria for subjects with primary brain tumors. Subjects with non-brain primary tumors must have previously received treatment with a TRK inhibitor and a documented resistance mutation(s) (e.g., solvent front, gatekeeper or xDFG mutation). Archival tissue from a prior biopsy taken after the subject completed TRK inhibitor treatment but prior to additional systemic therapy may be used to meet this eligibility criterion with Medical Monitor approval. Subjects with primary brain tumors may have received prior treatment with a TRK inhibitor but this is not required. Biopsies of brain tumors are not required for eligibility.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, estimated as an average of 36 months
Awards & highlights
Study Summary
This trial is testing a new drug, PBI-200, to treat subjects with NTRK-fusion-positive solid tumors. The trial will assess the safety and efficacy of the drug.
Who is the study for?
This trial is for people with advanced or metastatic solid tumors that have a specific genetic change called NTRK-fusion. Participants must have tried at least one treatment before, or there should be no approved treatments available. Those with brain tumors can join even if they haven't used TRK inhibitors, but others need to have tried and become resistant to these drugs.Check my eligibility
What is being tested?
PBI-200 is being tested in this study for its safety and effectiveness against solid tumors with the NTRK-fusion gene alteration. It's an early-stage trial involving increasing doses of PBI-200 to find out how much can be given safely and how it affects the body (pharmacokinetics) and tumor markers (biomarkers).See study design
What are the potential side effects?
Since this is a first-in-human study, exact side effects are unknown; however, potential risks may include typical reactions to cancer therapies such as nausea, fatigue, allergic reactions, blood count changes leading to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, estimated as an average of 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, estimated as an average of 36 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 AEs
Phase 1: Recommended Phase 2 Dose
Phase 2: Cohort A - Overall Response Rate (ORR)
+1 moreSecondary outcome measures
Duration of Response (DoR)
Phase 1: Area under the plasma drug concentration-time curve from 0 to 24 hours after one dose and after 28 doses
Phase 1: ORR
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2 Cohort ExpansionExperimental Treatment1 Intervention
Group II: Phase 1 Dose EscalationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PBI-200
2021
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Pyramid BiosciencesLead Sponsor
6 Previous Clinical Trials
138 Total Patients Enrolled
Chief Medical OfficerStudy DirectorPyramid Biosciences
122 Previous Clinical Trials
21,495 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had certain cancer treatments in the weeks before starting PBI-200.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Dose Escalation
- Group 2: Phase 2 Cohort 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.
How many individuals have enrolled in the trial thus far?
"Affirmative, per the info found on clinicaltrials.gov this research is actively enrolling people. The trial was first published on July 20th 2021 and most recently updated on September 13th 2022. In total, 74 patients are expected to be recruited from 11 sites."
Answered by AI
How many healthcare facilities are administering this research endeavor?
"Patients can join this trial at 11 different locations, such as Sarah Cannon Research Institute at HealthONE in Denver, Miami Cancer Institute in Miami and Sylvester Comprehensive Cancer Center (University of Miami) in Philadelphia. The other 8 sites are also currently recruiting participants."
Answered by AI
Are there any slots still available for this research endeavor?
"Affirmative. Per the information available on clinicaltrials.gov, this medical trial has opened recruitment and is searching for 74 participants from 11 different sites. The study was posted online in July of 2021 and most recently updated in September 2022."
Answered by AI
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