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Experimental cancer drug BBI-825 tested in early trial

NCT ID NCT06299761

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested an oral drug called BBI-825 in 19 people with advanced solid tumors that had stopped responding to standard treatments. The goal was to find a safe dose and check for side effects. The study was terminated early, so results are limited.

What this could mean

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

Active substance
BBI-825 (an oral ribonucleotide reductase inhibitor)
What this could lead to
If successful, this could point toward a new treatment option for advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is a very early (Phase 1/2) trial that was terminated early with only 19 participants, so results are limited and may not apply to larger populations. The drug may cause side effects or fail to shrink tumors.

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

19 people

The number who actually took part.

Started

Mar 2024

Finished

Jun 2025

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 to 99 years

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.

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, * 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. Exclusion Criteria: * Prior exposure to a selective RNR inhibitor (Note: Prior exposure to chemotherapies with nonselective RNR inhibitory activity e.g., gemcitabine is permitted), * Receipt of any approved or considered standard of care anticancer drug(s) or biological product(s) within 4 weeks or 5 half-lives, * 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, * Concurrent use of strong inhibitors or inducers of CYP3A, CYP2C8, CYP2C9, or CYP2C19, * Other exclusion criteria per study protocol.

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As listed by the trial registrant

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

Solid tumor

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • NEXT Oncology

    Irving, Texas, 75039, United States

  • NEXT Oncology

    San Antonio, Texas, 78229, United States

  • START Midwest

    Grand Rapids, Michigan, 49546, United States

  • Sarcoma Oncology Research Center

    Santa Monica, California, 90403, United States

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