Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer (KOMODO-1)

April 9, 2026 updated by: Boundless Bio, Inc.

An Open-Label, Multicenter, First-in-Human, Phase 1 Study of BBI-940 in Advanced or Metastatic Breast Cancer: Kinesin Oral Molecular Degrader for Oncology (KOMODO-1)

This is a first-in-human, open-label, Phase 1 study evaluating BBI-940, an investigational kinesin oral molecular degrader, administered as monotherapy or in combination with fulvestrant in adults with advanced or metastatic breast cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study consists of two parts: Part 1 (dose escalation) and Part 2 (dose expansion).

Part 1 is a dose-escalation phase designed to evaluate the safety and tolerability of BBI-940 and to determine the recommended dose for expansion (RDE). Participants may have estrogen receptor-positive, HER2-negative (ER+/HER2-) breast cancer or triple-negative breast cancer of the luminal androgen receptor subtype (TNBC-LAR).

Part 2 is a dose-expansion phase designed to further evaluate BBI-940 at the selected RDE in defined participant populations.

Part 2A evaluates BBI-940 in combination with fulvestrant, including multiple dose cohorts to evaluate the safety of the combination regimen and to determine the combination RDE in participants with ER+/HER2- breast cancer without an ESR1 mutation.

Part 2B evaluates BBI-940 monotherapy at the RDE in participants with ER+/HER2- breast cancer with FGFR1 amplification.

Part 2C evaluates BBI-940 monotherapy at the RDE in participants with TNBC-LAR.

Across all parts of the study, treatment is administered in repeated 28-day cycles, and participants undergo protocol-specified safety assessments.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • The START Center for Cancer Research
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • The START Center for Cancer Research
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • NEXT Oncology
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77054
        • Recruiting
        • NEXT Oncology
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • NEXT Oncology
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • The START Center for Cancer Care
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria

  • Adults with locally advanced or metastatic breast cancer, including estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) disease or triple-negative breast cancer with luminal androgen receptor subtype (TNBC-LAR; androgen receptor expression ≥10% by immunohistochemistry), as applicable by study part.
  • Prior treatment with standard therapies known to provide clinical benefit, appropriate for disease subtype and study part, including endocrine therapy with CDK4/6 inhibition for ER+/HER2- disease.
  • Measurable disease per RECIST v1.1, except for participants enrolled in Part 1A.
  • Molecular eligibility as applicable by study part, including absence of an ESR1 mutation (Part 2A) or presence of FGFR1 amplification (Part 2B), based on prior local testing.
  • Availability of archival or newly obtained formalin-fixed, paraffin-embedded (FFPE) tumor tissue suitable for protocol-specified biomarker analyses.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate hematologic, hepatic, renal, and coagulation function per protocol-defined laboratory criteria.
  • Estimated life expectancy of at least 12 weeks.
  • Ability to swallow oral medication and provide written informed consent.

Key Exclusion Criteria

  • Prior exposure to an inhibitor or degrader of Kinesin.
  • Known hypersensitivity to study intervention(s) or excipients.
  • Receipt of recent anticancer therapy within protocol-defined washout periods.
  • Other active malignancy likely to interfere with study assessment.
  • Baseline QTcF >470 msec or congenital long QT syndrome.
  • Clinically significant pulmonary embolism within 6 weeks prior to first dose.
  • Major surgery within 4 weeks or minor surgery within 2 weeks prior to first dose.
  • Active infection requiring systemic therapy within 2 weeks prior to first dose.
  • Pregnant or breastfeeding, or planning conception or gamete donation during the study or required post-treatment period.
  • Prior solid organ transplant or allogeneic stem cell transplant with protocol-defined exceptions.
  • Failure to recover to CTCAE Grade ≤1 (or baseline) from prior anticancer therapy, with protocol-specified exceptions.
  • Any serious or uncontrolled medical, laboratory, or psychiatric condition that could compromise safety or study integrity.
  • Other exclusion criteria as specified in the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Parts 1A, 1B. BBI-940 Monotherapy Escalation
Participants receive BBI-940 given alone in multiple sequential dose escalation cohorts. BBI-940 is given orally in repeated 28-day cycles.
Drug: BBI-940
Oral small molecule degrader targeting Kinesin.
Experimental: Part 2A. BBI-940 in Combination with Fulvestrant (ER+/HER2- Breast Cancer without an ESR1 Mutation)
Participants receive BBI-940 in combination with fulvestrant. BBI-940 is given orally in repeated 28-day cycles at one of multiple potential dose levels.
Drug: BBI-940
Oral small molecule degrader targeting Kinesin.
Drug: Fulvestrant
Selective estrogen receptor degrader administered intramuscularly.
Experimental: Part 2B. BBI-940 Monotherapy Expansion (ER+/HER2- Breast Cancer with FGFR1 Amplification)
Participants receive BBI-940 given alone at the recommended dose for expansion (RDE). BBI-940 is given orally in repeated 28-day cycles.
Drug: BBI-940
Oral small molecule degrader targeting Kinesin.
Experimental: Part 2C. BBI-940 Monotherapy Expansion (TNBC-LAR)
Participants receive BBI-940 given alone at the recommended dose for expansion (RDE). BBI-940 is given orally in repeated 28-day cycles.
Drug: BBI-940
Oral small molecule degrader targeting Kinesin.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of dose limiting toxicities (DLTs) in each BBI-940 monotherapy dose escalation cohort.
Time Frame: First 28 days of study treatment (through end of Cycle 1).
DLTs will be assessed during the first 28 days of study treatment (Cycle 1) to establish the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of BBI-940 as monotherapy.
First 28 days of study treatment (through end of Cycle 1).
Incidence of treatment emergent adverse events (TEAEs) in each dose group and overall as assessed by CTCAE version 5.0.
Time Frame: First dose of study treatment through 30 days after the last dose of study treatment.
Incidence of treatment emergent adverse events (TEAEs) will be assessed by maximum severity and maximum causality.
First dose of study treatment through 30 days after the last dose of study treatment.
Incidence of study treatment discontinuation and/or interruption by dose group and overall.
Time Frame: First dose of study treatment through 30 days after the last dose of study treatment.
The incidence of study treatment discontinuation and/or interruption will be assessed.
First dose of study treatment through 30 days after the last dose of study treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) per RECIST Version 1.1 by dose group and overall.
Time Frame: From first dose of study treatment until disease progression per RECIST 1.1, death, withdrawal, loss to follow-up, or study completion; tumor assessments every 8 weeks (±7 days); assessed up to approximately 3 years.
Objective response rate (ORR) will be summarized by dose group and overall, based on the number of participants achieving a best response of partial response or complete response.
From first dose of study treatment until disease progression per RECIST 1.1, death, withdrawal, loss to follow-up, or study completion; tumor assessments every 8 weeks (±7 days); assessed up to approximately 3 years.
Time of maximum plasma concentration (Tmax) of BBI-940.
Time Frame: From 0 hours through up to 24 hours after BBI-940 dosing.
Time of maximum plasma concentration (Tmax) of BBI-940 will be determined.
From 0 hours through up to 24 hours after BBI-940 dosing.
Maximum observed plasma concentration (Cmax) of BBI-940.
Time Frame: From 0 hours through up to 24 hours after BBI-940 dosing.
Maximum observed plasma concentration (Cmax) of BBI-940 will be determined.
From 0 hours through up to 24 hours after BBI-940 dosing.
Minimum observed plasma concentration (Ctrough) of BBI-940.
Time Frame: From 0 hours through up to 24 hours after BBI-940 dosing.
Minimum observed plasma concentration (Ctrough) of BBI-940 will be determined.
From 0 hours through up to 24 hours after BBI-940 dosing.
Area under the plasma concentration-time curve (AUC) of BBI-940.
Time Frame: From 0 hours through up to 24 hours after BBI-940 dosing.
Area under the plasma concentration-time curve (AUC) of BBI-940 will be determined.
From 0 hours through up to 24 hours after BBI-940 dosing.
Progression Free Survival (PFS) per RECIST Version 1.1 by dose group and overall.
Time Frame: From first dose of study treatment until first documented disease progression per RECIST 1.1 or death from any cause, whichever occurs first; tumor assessments every 8 weeks (±7 days); assessed up to approximately 3 years.
Progression-free survival is defined as the time from first dose of study treatment to the first documented disease progression per RECIST Version 1.1 or death from any cause, whichever occurs first.
From first dose of study treatment until first documented disease progression per RECIST 1.1 or death from any cause, whichever occurs first; tumor assessments every 8 weeks (±7 days); assessed up to approximately 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boundless Bio, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Robert C. Doebele, MD, PhD, Boundless Bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BBI-940-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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