A Phase 1/2 Study of PBI-200 in Subjects With NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors

Status: Terminated
Location: See all (42) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a first-in-human, open-label, multicenter, dose-escalation, safety, PK, and biomarker study of PBI-200 in subjects with NTRK-fusion-positive advanced or metastatic solid tumors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
John Wayne Cancer Institute at St. Johns Health Center
Santa Monica
Stanford Hospital and Clinics
Stanford
Colorado
Sarah Cannon Research Institute at HealthONE
Denver
Florida
Florida Cancer Specialists
Lake Mary
Miami Cancer Institute
Miami
Sylvester Comprehensive Cancer Center (University of Miami)
Miami
Massachusetts
Dana-Farber Cancer Institute
Boston
New York
Westchester Medical Center
Hawthorne
Pennsylvania
Thomas Jefferson University Hospital
Philadelphia
Tennessee
Tennessee Oncology, PLLC
Nashville
Texas
The University of Texas MD Anderson Cancer Center
Houston
Other Locations
Australia
Peter MacCallum Cancer Centre
Melbourne
Denmark
Rigshospitalet, University Hospital of Copenhagen
Copenhagen
France
Institut Bergonie
Bordeaux
Centre Léon Bérard
Lyon
Hopital Europeen Georges Pompidou
Paris
CHU Poitiers - Hopital la Miletrie
Poitiers
Institut Gustave Roussy
Villejuif
Germany
Dr. Senckenberg Institute of Neurooncology
Frankfurt Am Main
Universitaetsklinikum Heidelberg
Heidelberg
Marienhospital Herne
Herne
Hong Kong Special Administrative Region
Queen Mary Hospital
Pok Fu Lam
Prince of Wales Hospital
Shatin
Italy
Azienda Ospedaliero Universitaria delle Marche
Ancona
Fondazione IRCCS Istituto Nazionale Tumori
Milan
IRCCS (IEO) Istituto Europeo di Oncologia
Milan
IRCCS Ospedale San Raffaele
Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Napoli
Azienda Ospedaliera Universitaria Integrata Verona
Verona
Republic of Korea
Seoul National University Bundang Hosptial
Seongnam-si
Samsung Medical Center
Seoul
Severance Hosptial, Yonsei University Health System
Seoul
The Catholic University of Korea Soul St. Mary's Hosptial
Seoul
The Catholic University of Korea St. Vincent Hosptial
Suwon
Singapore
National Cancer Centre Singapore
Singapore
Spain
Hospital Universitari Vall d Hebron
Barcelona
ICO l Hospitalet
L'hospitalet De Llobregat
Hospital Universitario La Paz
Madrid
Hospital Universitario Ramon y Cajal
Madrid
Hospital General de Catalunya
Sant Cugat Del Vallès
United Kingdom
The Christie
Manchester
Royal Marsden Hospital Institute Cancer Research
Sutton
Time Frame
Start Date: 2021-07-20
Completion Date: 2023-07-26
Participants
Target number of participants: 29
Treatments
Experimental: Phase 1 Dose Escalation
Experimental: Phase 2 Cohort Expansion
Sponsors
Leads: Pyramid Biosciences

This content was sourced from clinicaltrials.gov