← Back to Search

Virus Therapy

PBI-200 for Solid Tumors

Verona, Italy
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
Must not have
Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy ≤ 3 weeks prior to the first dose of PBI-200 (6 weeks for nitrosoureas). Subjects with either primary brain tumors or brain metastasis must have completed brain radiation therapy 12 weeks prior to the brain MRI obtained within 4 weeks of the first dose of PBI-200. Small-molecule kinase inhibitors or hormonal agents ≤ 14 days and within 5 half-lives prior to the first dose of PBI-200.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, estimated as an average of 36 months
Awards & highlights
No Placebo-Only Group

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.

See full description
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 below
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't had certain cancer treatments in the weeks before starting PBI-200.
 show original

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, estimated as an average of 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, estimated as an average of 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1: Number of patients with AEs
Phase 2: Cohort A - Overall Response Rate (ORR)
Phase 2: Cohort B - ORR
Secondary study objectives
Duration of Response (DoR)
Phase 1: ORR
Progression-free Survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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

Closest Location:Sarah Cannon Research Institute at HealthONE· Denver, CO· 410 miles

Who is running the clinical trial?

Pyramid BiosciencesLead Sponsor
7 Previous Clinical Trials
418 Total Patients Enrolled
Chief Medical OfficerStudy DirectorPyramid Biosciences
133 Previous Clinical Trials
22,180 Total Patients Enrolled
1 Trials studying Desmoplastic Small Round Cell Tumor
25 Patients Enrolled for Desmoplastic Small Round Cell Tumor

Media Library

PBI-200 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04901806 — Phase 1
Desmoplastic Small Round Cell Tumor Research Study Groups: Phase 1 Dose Escalation, Phase 2 Cohort Expansion
Desmoplastic Small Round Cell Tumor Clinical Trial 2023: PBI-200 Highlights & Side Effects. Trial Name: NCT04901806 — Phase 1
PBI-200 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04901806 — Phase 1
~6 spots leftby Mar 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top