Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05827614 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Triple Negative Breast Cancer (TNBC) and Cervical Squamous Cell Carcinoma, sponsored by Boundless Bio.

Active
Registry status
Phase 1
Development phase
85
Enrollment target
16
Study locations

NCT05827614: Active Phase 1 study of Triple Negative Breast Cancer (TNBC) and Cervical Squamous Cell Carcinoma, sponsored by Boundless Bio.

NCT05827614 is a Phase 1 study of Triple Negative Breast Cancer (TNBC) and Cervical Squamous Cell Carcinoma that is active but no longer recruiting, run by Boundless Bio. The registered enrollment target is 85 participants, below the 152-participant average among 14 other Triple Negative Breast Cancer (TNBC) trials with a reported enrollment target (44% lower). The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05827614, a Phase 1 study of Triple Negative Breast Cancer (TNBC) and Cervical Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Boundless Bio.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
85 participants
Enrollment target
16
Study locations

Study Summary

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.

Primary Outcome

TEAEs will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

Conditions Studied

Triple Negative Breast Cancer (TNBC) Cervical Squamous Cell Carcinoma ER+ Breast Cancer Cutaneous Squamous Cell Carcinoma (CSCC) High-grade Serous Ovarian Carcinoma Head and Neck (HNSCC) High Grade Endometrial Carcinoma Anogenital Cancer Leiomyosarcoma (LMS) Undifferentiated Pleomorphic Sarcoma (UPS)

Interventions

  • DRUG Futibatinib
  • DRUG Erlotinib
  • DRUG BBI-355
  • DRUG BBI-825

Study Locations (16)

Texas

  • MD Anderson Cancer Center - Houston
  • NEXT Oncology - Dallas - Irving
  • NEXT Oncology - San Antonio

California

  • UCLA Medical Center - Los Angeles
  • Sarcoma Oncology - Santa Monica

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston
  • Dana Farber Cancer Institute - Boston

Colorado

  • HealthONE - Denver

Florida

  • Florida Cancer Specialists - Lake Mary

Kansas

  • The University of Kansas - Fairway

Michigan

  • START Midwest - Grand Rapids

New York

  • Memorial Sloan Kettering Cancer Center - New York

Trial Details

FieldValue
Enrollment Target 85 participants
Start Date 2023-03-24
Est. Completion 2027-03-31
Phase Phase 1
Boundless Bio

3 total trials

What the registry record for NCT05827614 still lists

NCT05827614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 152-participant average among 14 other Triple Negative Breast Cancer (TNBC) trials with a reported enrollment target (44% lower).

The record links to 10 conditions, with Triple Negative Breast Cancer (TNBC) appearing as the primary indexed condition, and to 4 interventions - of which Futibatinib is the first listed.

NCT05827614 lists 16 locations in 12 states (Texas, California, Massachusetts).

Frequently Asked Questions

What is clinical trial NCT05827614 about?

NCT05827614 is a clinical study titled "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-la...

What is the current status of trial NCT05827614?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2023-03-24. Estimated completion is 2027-03-31.

What conditions does trial NCT05827614 study?

This clinical trial studies the following conditions: Triple Negative Breast Cancer (TNBC), Cervical Squamous Cell Carcinoma, ER+ Breast Cancer, Cutaneous Squamous Cell Carcinoma (CSCC), High-grade Serous Ovarian Carcinoma.

What interventions are being tested in trial NCT05827614?

The interventions under investigation include: Futibatinib (DRUG), Erlotinib (DRUG), BBI-355 (DRUG), BBI-825 (DRUG).

Who is sponsoring clinical trial NCT05827614?

This trial is sponsored by Boundless Bio, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05827614 being conducted?

This trial has 16 study locations across California, Colorado, Florida, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Triple Negative Breast Cancer (TNBC)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05827614's enrollment target sits among peer trials

85 10th of 14 higher than 5 of 14 other Triple Negative Breast Cancer (TNBC) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Triple Negative Breast Cancer (TNBC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00842283 · 85 participants

    Role of Angiogenesis in Dermatologic Diseases: A Potential Therapeutic Target

  • NCT02133196 · 85 participants · Phase 2

    T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer

  • NCT03823144 · 85 participants · NA

    Intravital Microscopy in Human Solid Tumors

  • NCT03875638 · 85 participants · Phase 2

    Treating Hyperexcitability in AD With Levetiracetam

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT05827614, the US trial registry maintained by the National Library of Medicine. NCT05827614 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.