PBI-200 in NTRK-Fusion-Positive Solid Tumors

Treatment of PBI-200 in Subjects With NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors

Agents: PBI-200
Phase I/II
Status Not recruiting, but active
Sponsor Pyramid Biosciences

 

For further information please also consult ClinicalTrials.gov.

 

This is a first-in-human, Phase 1/2 open-label, multicenter study of PBI-200 in NTRK-fusion-positive advanced or metastatic solid tumors.

WHO is the trial for?

  • Patients of 18 years and older, with a diagnosis of a solid, locally advanced or metastatic, NTRK-fusion-positive tumor
  • Progression after at least one systemic therapy regimen
  • Not amenable to surgical resection

Patient who had cytotoxic chemotherapy, a biologic agent, an investigational agent, or radiation therapy ≤ 3 weeks prior to the first dose of PBI-200 (6 weeks for nitrosoureas) are not eligable to be enrolled in this study.

WHAT is the key question that this trial is attempting to answer?

The primary objective of this trial is to systematically assess the optimal dosage, safety and amongst others the biomarker responses of PBI-200 in patients with NTRK-fusion-positive advanced or metastatic solid tumors.

WHY patients might want to participate?

The study's design includes dose escalation (finding the optimal dosage) and expanded cohorts for specific tumor types. It offers participants the opportunity to potentially benefit from innovative and novel treatments.

WHEN will the trial be open?

This study is closed for recruitment, but active.

WHERE is the trial available?

The trial is being conducted in Australia, Denmark, France, Germany, Hong Kong, Italy, Korea, Singapore, Spain, United Kingdom and the United States.

For further information please check here.

Contact: Mel McMahon
Phone Number:888-850-0650

STUDY DESIGN: What does the study look like?

This is a phase 1/2 study that assesses PBI-200 for the first time in humans. Patients which have a confirmed NTRK fusion and an advanced or metastatic solid tumore can enter this study.PBI-200 will be administered orally (by mouth) over continuous 28-day cycles.

Phase 1 is the dose-escalation portion of the study in which the evaluation of safety and
tolerability and establishing the highest dose with acceptable toxicity are primary objectives.

Once this has been established, two expansion cohorts will open to accrual: a Non-Brain Primary Tumor
cohort and a Primary Brian Tumor cohort.

HOW do I get more information?

ClinicalTrials.gov, cancer societies or cancer focused patient advocacy groups in your country may offer
additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient
organizations that might be helpful. If there are no such organization in your country, please email us for
more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken