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New cancer drug BBI-355 trial halted early – what we know

NCT ID NCT05827614

Disease control Sponsor: Boundless Bio, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This early-phase trial tested a new oral drug called BBI-355, alone or with other targeted therapies, in people with advanced solid tumors that had extra DNA (oncogene amplifications). The study aimed to find the safest dose and check for side effects. It was terminated early, so full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BBI-355 (a CHK1 inhibitor drug)
What this could lead to
If successful, this could point toward a new treatment option for certain advanced cancers that have extra DNA in their cells.
What could go wrong
This was a very early (Phase 1/2) study that was terminated, so results are limited. The drug may not prove safe or effective, and it was tested only in people who had already tried all standard treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

85 people

The number who actually took part.

Started

Mar 2023

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cervical squamous cell carcinoma estrogen-receptor positive breast cancer head and neck squamous cell carcinoma leiomyosarcoma malignant pancreatic neoplasm neoplasm ovarian serous adenocarcinoma skin squamous cell carcinoma small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma undifferentiated pleomorphic sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anogenital cancer Cervical squamous cell carcinoma Cutaneous squamous cell carcinoma (CSCC) ER+ breast cancer Head and neck (HNSCC) High grade endometrial carcinoma High-grade serous ovarian carcinoma Leiomyosarcoma (LMS) Pancreatic cancer metastatic Small cell lung cancer Triple negative breast cancer (TNBC) Undifferentiated pleomorphic sarcoma (UPS)

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists

    Lake Mary, Florida, 32746, United States

  • HealthONE

    Denver, Colorado, 80218, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77054, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • NEXT Oncology

    San Antonio, Texas, 78229, United States

  • NEXT Oncology

    Fairfax, Virginia, 22031, United States

  • NEXT Oncology - Dallas

    Irving, Texas, 75039, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • START Midwest

    Grand Rapids, Michigan, 49546, United States

  • Sarcoma Oncology

    Santa Monica, California, 90403, United States

  • The University of Kansas

    Fairway, Kansas, 66205, United States

  • UCLA Medical Center

    Los Angeles, California, 90095, United States

  • University of Washington, Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.