An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination With Select Targeted Therapies in Subjects With Locally Advanced or Metastatic Solid Tumors With Oncogene Amplifications
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
BBI-355 is an oral, potent, selective checkpoint kinase 1 (or CHK1) small molecule inhibitor in development as an ecDNA (extrachromosomal DNA) directed therapy (ecDTx). BBI-825 is an oral, potent, selective ribonucleotide reductase (or RNR) small molecule inhibitor. This is a first-in-human, open-label, 2-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-355 administered as a single agent or in combination with BBI-825 or other select therapies.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists,
• Evidence of oncogene amplification,
• Availability of FFPE tumor tissue, archival or newly obtained,
• Measurable disease as defined by RECIST Version 1.1,
• Adequate hematologic function,
• Adequate hepatic and renal function,
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1,
• Other inclusion criteria per study protocol.
Locations
United States
California
UCLA Medical Center
ACTIVE_NOT_RECRUITING
Los Angeles
Sarcoma Oncology
TERMINATED
Santa Monica
Colorado
HealthONE
RECRUITING
Denver
Florida
Florida Cancer Specialists
ACTIVE_NOT_RECRUITING
Lake Mary
Kansas
The University of Kansas
ACTIVE_NOT_RECRUITING
Fairway
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Michigan
START Midwest
RECRUITING
Grand Rapids
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
South Carolina
Medical University of South Carolina
WITHDRAWN
Charleston
Tennessee
SCRI Oncology Partners
ACTIVE_NOT_RECRUITING
Nashville
Texas
MD Anderson Cancer Center
RECRUITING
Houston
NEXT Oncology - Dallas
RECRUITING
Irving
NEXT Oncology
RECRUITING
San Antonio
Virginia
NEXT Oncology
RECRUITING
Fairfax
Washington
University of Washington, Fred Hutchinson Cancer Center
RECRUITING
Seattle
Wisconsin
University of Wisconsin
ACTIVE_NOT_RECRUITING
Madison
Contact Information
Primary
Angela Pietrofeso
Clinicaltrials@boundlessbio.com
16198211090
Backup
Rebecca Reynolds
Clinicaltrials@boundlessbio.com
16198211090
Time Frame
Start Date:2023-03-24
Estimated Completion Date:2027-03-31
Participants
Target number of participants:127
Treatments
Experimental: Single Agent Dose Escalation
Single agent BBI-355, administered orally in 28-day cycles
Experimental: Single Agent Dose Expansion
Single agent BBI-355, administered orally in 28-day cycles
Experimental: Dose Escalation in Combination with EGFR Inhibitor
Combination therapy of BBI-355 and EGFR inhibitor erlotinib, administered orally in 28-day cycles.
Experimental: Dose Escalation in Combination with FGFR Inhibitor
Combination therapy of BBI-355 and FGFR1-4 inhibitor futibatinib, administered orally in 28-day cycles.
Experimental: Dose Escalation in Combination with RNR Inhibitor
Combination therapy of BBI-355 and RNR Inhibitor BBI-825, administered orally in 28-day cycles.