CHK1 inhibitor BBI-355 for tumors with oncogene amplifications
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
This study is testing a new oral medication called BBI-355 to see if it can help patients with advanced solid tumors that have certain genetic changes, especially when other treatments haven't worked.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boundless Bio Industry-sponsored |
| Drugs / interventions | erlotinib, futibatinib |
| Locations | 16 sites (Los Angeles, California and 15 other locations) |
| Trial ID | NCT05827614 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates BBI-355, an oral CHK1 inhibitor, as a treatment for patients with locally advanced or metastatic solid tumors that have oncogene amplifications. The study is designed to determine the safety profile and establish the maximum tolerated dose of BBI-355, administered either alone or in combination with other therapies like erlotinib and futibatinib. Participants must have tumors that have progressed despite standard therapies, and the trial includes various dosing schedules to assess efficacy and safety.
Who should consider this trial
Good fit: Ideal candidates include individuals with non-resectable solid tumors that have progressed after standard therapies and show evidence of oncogene amplification.
Not a fit: Patients with well-known tumor activating oncogene mutations or prior exposure to CHK1 inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that currently have limited treatment options.
How similar studies have performed: Other studies have shown promise with similar approaches targeting oncogene amplifications, but this specific therapy is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 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, * Single agent arm: Evidence of oncogene amplification, * BBI-355 combination with erlotinib arm: Evidence of amplification of wildtype EGFR, * BBI-355 combination with futibatinib arm: Evidence of amplification of wildtype FGFR1, FGFR2, FGFR3, or FGFR4, * 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. Key Exclusion Criteria: * Well-known tumor activating oncogene mutations or fusions, * Prior exposure to CHK1 inhibitors, * BBI-355 combination with erlotinib arm: Prior exposure to EGFR inhibitors, * BBI-355 combination with futibatinib arm: Prior exposure to FGFR inhibitors, * Hematologic malignancies, * Primary CNS malignancy, leptomeningeal disease, or symptomatic active CNS metastases, with exceptions per study protocol, * Prior or concurrent malignancies, with exceptions per study protocol, * History of HBV, HCV, or HIV infection, * Clinically significant cardiac condition, * Active or history of interstitial lung disease (ILD) or pneumonitis, or history of ILD or pneumonitis requiring steroids or other immunosuppressive medications, * QTcF \> 470 msec, * Prior organ allograft transplantations or allogeneic peripheral blood stem cell/bone marrow transplantation, * Other exclusion criteria per study protocol.
Where this trial is running
Los Angeles, California and 15 other locations
- UCLA Medical Center — Los Angeles, California, United States (Recruiting)
- Sarcoma Oncology — Santa Monica, California, United States (Recruiting)
- HealthONE — Denver, Colorado, United States (Recruiting)
- Florida Cancer Specialists — Lake Mary, Florida, United States (Recruiting)
- The University of Kansas — Fairway, Kansas, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- START Midwest — Grand Rapids, Michigan, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- NEXT Oncology - Dallas — Irving, Texas, United States (Recruiting)
- NEXT Oncology — San Antonio, Texas, United States (Recruiting)
- NEXT Oncology — Fairfax, Virginia, United States (Recruiting)
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Sara Weymer
- Email: Clinicaltrials@boundlessbio.com
- Phone: 16198211090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.