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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

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NCT05827614

Sponsored by Boundless Bio, Inc. (industry) · BOLD — their whole pipeline →.

Phase
Phase 1
Status
Terminated
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
85actual
Sites
16
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Why the sponsor stopped it

Decision was made to halt the study based on overall clinical experience and market considerations. This decision was not driven by any safety signal.

As filed on the registry record, in the sponsor's own words.

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2023-03-24actualWhen the study began enrolling
Primary completion2026-03-17actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-03-17actualThe whole study's end, after follow-up
First posted2023-04-25actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-19actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

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

Interventions

  • Drug: BBI-355
  • Drug: Erlotinib
  • Drug: Futibatinib
  • Drug: BBI-825

Primary outcomes

what the primary-completion date above is the date OF
Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-355 as a single agent and in combination with each of the following agents: erlotinib, futibatinib, or BBI-825
measured Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-355 as a single agent and in combination with erlotinib, futibatinib, or BBI-825
measured Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)

Publications

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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