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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05827614
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 85 participants
Conditions and interventions
Conditions
- Triple Negative Breast Cancer (TNBC)
- High Grade Serous Ovarian Carcinoma
- High Grade Endometrial Carcinoma
- Anogenital Cancer
- Head and Neck (HNSCC)
- Cutaneous Squamous Cell Carcinoma (CSCC)
- Cervical Squamous Cell Carcinoma
- ER+ Breast Cancer
- Leiomyosarcoma (LMS)
- Undifferentiated Pleomorphic Sarcoma (UPS)
- Pancreatic Cancer Metastatic
- Small Cell Lung Cancer
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 24, 2023 (Actual)
- Primary completion
- Mar 17, 2026 (Actual)
- Completion
- Mar 17, 2026 (Actual)
- Last update posted
- Aug 19, 2026
2023 – 2026
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 Aug 19, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05827614 live on ClinicalTrials.gov.