Breast CancerPhase 1KOMODO-1NCT07408089
Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer
A Phase 1 study testing BBI-940 and Fulvestrant in people with Breast Cancer and Metastatic Breast Cancer, run by Boundless Bio, Inc. at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer
- What is being tested?
- BBI-940 and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 8 sitesUnited States
- Study dates
- 25 Feb 2026to 28 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
NEXT Oncology
Austin, Texas, 78758
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
NEXT Oncology
Fairfax, Virginia, 22031
NEXT Oncology
Houston, Texas, 77054
The START Center for Cancer Research
Lake Success, New York, 11042
The START Center for Cancer Research
Los Angeles, California, 90025
NEXT Oncology
San Antonio, Texas, 78229
The START Center for Cancer Care
San Antonio, Texas, 78229
About this study
Official title: 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.
Read the 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.
- Being tested
- BBI-940, Fulvestrant
- Keywords
- Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Phase 1, First in Human, BBI-940, Fulvestrant, FGFR1
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBI-940Drug
Oral small molecule degrader targeting Kinesin.
FulvestrantDrug
Selective estrogen receptor degrader administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Parts 1A, 1B. BBI-940 Monotherapy Escalation | Experimental | Participants receive BBI-940 given alone in multiple sequential dose escalation cohorts. BBI-940 is given orally in repeated 28-day cycles. Receives: Drug: BBI-940 |
| Part 2A. BBI-940 in Combination with Fulvestrant (ER+/HER2- Breast Cancer without an ESR1 Mutation) | Experimental | 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. Receives: Drug: BBI-940; Drug: Fulvestrant |
| Part 2B. BBI-940 Monotherapy Expansion (ER+/HER2- Breast Cancer with FGFR1 Amplification) | Experimental | Participants receive BBI-940 given alone at the recommended dose for expansion (RDE). BBI-940 is given orally in repeated 28-day cycles. Receives: Drug: BBI-940 |
| Part 2C. BBI-940 Monotherapy Expansion (TNBC-LAR) | Experimental | Participants receive BBI-940 given alone at the recommended dose for expansion (RDE). BBI-940 is given orally in repeated 28-day cycles. Receives: Drug: BBI-940 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of dose limiting toxicities (DLTs) in each BBI-940 monotherapy dose escalation cohort.
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.
Measured: 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.
Incidence of treatment emergent adverse events (TEAEs) will be assessed by maximum severity and maximum causality.
Measured: 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.
The incidence of study treatment discontinuation and/or interruption will be assessed.
Measured: First dose of study treatment through 30 days after the last dose of study treatment.
Secondary outcomes (6)
Objective response rate (ORR) per RECIST Version 1.1 by dose group and overall.
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.
Measured: 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.
Progression Free Survival (PFS) per RECIST Version 1.1 by dose group and overall.
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.
Measured: 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.
Time of maximum plasma concentration (Tmax) of BBI-940.
Time of maximum plasma concentration (Tmax) of BBI-940 will be determined.
Measured: From 0 hours through up to 24 hours after BBI-940 dosing.
Maximum observed plasma concentration (Cmax) of BBI-940.
Maximum observed plasma concentration (Cmax) of BBI-940 will be determined.
Measured: From 0 hours through up to 24 hours after BBI-940 dosing.
Minimum observed plasma concentration (Ctrough) of BBI-940.
Minimum observed plasma concentration (Ctrough) of BBI-940 will be determined.
Measured: From 0 hours through up to 24 hours after BBI-940 dosing.
Area under the plasma concentration-time curve (AUC) of BBI-940.
Area under the plasma concentration-time curve (AUC) of BBI-940 will be determined.
Measured: From 0 hours through up to 24 hours after BBI-940 dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start25 Feb 2026
- Primary completion28 Jul 2026
- Study completion28 Jul 2026
Why it stopped: The study was terminated primarily due to a business decision related to a corporate transaction and was not driven by any safety signal.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- BBI-940 single agent dose escalation and expansion, and BBI-940 dose expansion (at multiple potential dose levels) in combination with fulvestrant.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boundless Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert C. Doebele, MD, PhD, Study director, Boundless Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408089
- Sponsor's protocol ID
- BBI-940-101
- Acronym
- KOMODO-1
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07408089
- Acronym / sponsor ID
- KOMODO-1 / BBI-940-101
- Keywords
- Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Phase 1, First in Human, BBI-940, Fulvestrant, FGFR1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated primarily due to a business decision related to a corporate transaction and was not driven by any safety signal.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boundless Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 28 Jul 2026 (actual)
- Study completion
- 28 Jul 2026 (actual)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- BBI-940 single agent dose escalation and expansion, and BBI-940 dose expansion (at multiple potential dose levels) in combination with fulvestrant.
| Arm | Type | Receives |
|---|---|---|
| Parts 1A, 1B. BBI-940 Monotherapy Escalation | Experimental | Drug: BBI-940Participants receive BBI-940 given alone in multiple sequential dose escalation cohorts. BBI-940 is given orally in repeated 28-day cycles. |
| Part 2A. BBI-940 in Combination with Fulvestrant (ER+/HER2- Breast Cancer without an ESR1 Mutation) | Experimental | Drug: BBI-940, Drug: FulvestrantParticipants receive BBI-940 in combination with fulvestrant. BBI-940 is given orally in repeated 28-day cycles at one of multiple potential dose levels. |
| Part 2B. BBI-940 Monotherapy Expansion (ER+/HER2- Breast Cancer with FGFR1 Amplification) | Experimental | Drug: BBI-940Participants receive BBI-940 given alone at the recommended dose for expansion (RDE). BBI-940 is given orally in repeated 28-day cycles. |
| Part 2C. BBI-940 Monotherapy Expansion (TNBC-LAR) | Experimental | Drug: BBI-940Participants receive BBI-940 given alone at the recommended dose for expansion (RDE). BBI-940 is given orally in repeated 28-day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBI-940Oral small molecule degrader targeting Kinesin. | Drug | Part 2A. BBI-940 in Combination with Fulvestrant (ER+/HER2- Breast Cancer without an ESR1 Mutation), Part 2B. BBI-940 Monotherapy Expansion (ER+/HER2- Breast Cancer with FGFR1 Amplification), Part 2C. BBI-940 Monotherapy Expansion (TNBC-LAR), Parts 1A, 1B. BBI-940 Monotherapy Escalation |
| FulvestrantSelective estrogen receptor degrader administered intramuscularly. | Drug | Part 2A. BBI-940 in Combination with Fulvestrant (ER+/HER2- Breast Cancer without an ESR1 Mutation) |
Primary outcome
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.
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.
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.
6 secondary outcomes
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.
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.
Time of maximum plasma concentration (Tmax) 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.
Time frame: 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.
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.
Results and safety
The study was stopped early (reason given: The study was terminated primarily due to a business decision related to a corporate transaction and was not driven by any safety signal.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert C. Doebele, MD, PhD study director
Boundless Bio, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BBI-940 and Fulvestrant in people with Breast Cancer and Metastatic Breast Cancer, run by Boundless Bio, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated primarily due to a business decision related to a corporate transaction and was not driven by any safety signal.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.