Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), and the RNR Inhibitor BBI-825, in Subjects With Tumors With Oncogene Amplifications
Public ClinicalTrials.gov record NCT05827614. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT05827614
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Boundless Bio, Inc.
- Industry
- Enrollment
- 85 participants
Conditions and interventions
Conditions
- Anogenital Cancer
- Cervical Squamous Cell Carcinoma
- Cutaneous Squamous Cell Carcinoma (CSCC)
- ER+ Breast Cancer
- Head and Neck (HNSCC)
- High Grade Endometrial Carcinoma
- High Grade Serous Ovarian Carcinoma
- Leiomyosarcoma (LMS)
- Pancreatic Cancer Metastatic
- Small Cell Lung Cancer
- Triple Negative Breast Cancer (TNBC)
- Undifferentiated Pleomorphic Sarcoma (UPS)
Interventions
- BBI-355 Drug
- BBI-825 Drug
- Erlotinib Drug
- Futibatinib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 23, 2023
- Primary completion
- Sep 29, 2026
- Completion
- Mar 30, 2027
- Last update posted
- Jan 22, 2026
2023 – 2027
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | — |
| Sarcoma Oncology | Santa Monica | California | 90403 | — |
| HealthONE | Denver | Colorado | 80218 | — |
| Florida Cancer Specialists | Lake Mary | Florida | 32746 | — |
| The University of Kansas | Fairway | Kansas | 66205 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| START Midwest | Grand Rapids | Michigan | 49546 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | — |
| MD Anderson Cancer Center | Houston | Texas | 77054 | — |
| NEXT Oncology - Dallas | Irving | Texas | 75039 | — |
| NEXT Oncology | San Antonio | Texas | 78229 | — |
| NEXT Oncology | Fairfax | Virginia | 22031 | — |
| University of Washington, Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05827614, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 22, 2026 · Synced Apr 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05827614 live on ClinicalTrials.gov.