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 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.

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.

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

Sponsor

Boundless Bio

3 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05827614

The ClinicalTrials.gov registry entry for NCT05827614 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 152-participant average among 14 other Triple Negative Breast Cancer (TNBC) trials with a reported enrollment target (44% lower). The listed sponsor is Boundless Bio, which has 3 total studies on file at ClinicalTrials.gov.

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 reports 16 study locations spanning 12 distinct geographic areas - top geographies include 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.

Explore more on PlainTrial

Triple Negative Breast Cancer (TNBC)

All registered trials for this condition

Cervical Squamous Cell Carcinoma

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.