TerminatedPhase 1NCT05827614

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

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.

Checked against the public recordLast updated Aug 19, 2026 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 1
U.S. locations16
SponsorBoundless Bio, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Boundless Bio, Inc.
Interventions being studied
Drug: BBI-355; Drug: Erlotinib; Drug: Futibatinib; Drug: BBI-825
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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, * 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. Key Exclusion Criteria: * Single agent arm: Prior exposure to CHK1 or WEE1 inhibitors, * BBI-355 combination with BBI-825 arm: Prior exposure to combination therapy of any RNR inhibitor plus CHK1/2 inhibitor, * 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UCLA Medical CenterLos Angeles, California
  • Sarcoma OncologySanta Monica, California
  • HealthONEDenver, Colorado
  • Florida Cancer SpecialistsLake Mary, Florida
  • The University of KansasFairway, Kansas
  • Beth Israel Deaconess Medical CenterBoston, Massachusetts
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • START MidwestGrand Rapids, Michigan
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • SCRI Oncology PartnersNashville, Tennessee
  • MD Anderson Cancer CenterHouston, Texas
  • NEXT Oncology - DallasIrving, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 19, 2026. Always confirm current availability with the study team.

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