Solid TumorPhase 1STARMAPNCT06299761
Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications
A Phase 1 study testing BBI-825 in people with Solid Tumor, run by Boundless Bio, Inc. at 5 sites in United States.
Trial summary
BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- BBI-825
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Mar 2024to 25 Jun 2025
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
START Midwest
Grand Rapids, Michigan, 49546
NEXT Oncology
Irving, Texas, 75039
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
NEXT Oncology
San Antonio, Texas, 78229
Sarcoma Oncology Research Center
Santa Monica, California, 90403
About this study
Official title: An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-825 and BBI-825 in Combination With Select Targeted Therapies in Subjects With Locally Advanced or Metastatic Solid Tumors With Resistance Gene Amplifications
BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies.
Read the detailed description
BBI-825 will be administered orally (PO) twice daily (BID) to subjects with 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.
- Conditions
- Solid Tumor
- Being tested
- BBI-825
- Keywords
- Amplification, Oncogene Amplification, ribonucleotide reductase inhibitor, RNR inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBI-825Drug
Also called ribonucleotide reductase inhibitor
Oral RNR inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Single Agent Dose Escalation | Experimental | Single agent BBI-825, administered orally, twice daily, in 28-day cycles Receives: Drug: BBI-825 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-825
TEAEs will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Measured: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-825
The MTD and/or RP2D of BBI-825 will be determined.
Measured: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)
Secondary outcomes (5)
Maximum observed plasma concentration (Cmax) of BBI-825
Maximum observed plasma concentration (Cmax) of BBI-825 will be determined.
Measured: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)
Trough observed plasma concentration (Ctrough) of BBI-825
Trough observed plasma concentration (Ctrough) of BBI-825 will be determined.
Measured: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)
Time to Cmax (Tmax) of BBI-825
Time to Cmax (Tmax) of BBI-825 will be determined.
Measured: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)
Area under the concentration time curve (AUC) of BBI-825
Area under the concentration time curve (AUC) of BBI-825 will be determined.
Measured: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)
Anti-tumor activity of BBI-825 as determined by RECISTv1.1
Number of participants achieving a best response of progressive disease, stable disease, partial response, or complete response.
Measured: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start28 Mar 2024
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Why it stopped: Strategic decision made following an assessment of preliminary PK data from the Part 1 portion of the trial showing a lack of dose proportional exposure and the increasing complexity and associated development costs in this landscape.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- BBI-825 single agent dose escalation
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boundless Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Doebele, MD, Study director, Boundless Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299761
- Sponsor's protocol ID
- BBI-825-101
- Acronym
- STARMAP
- Status last verified
- Jun 2026
- First submitted
- 26 Feb 2024
- Last updated
- 8 Jun 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-825 and BBI-825 in Combination With Select Targeted Therapies in Subjects With Locally Advanced or Metastatic Solid Tumors With Resistance Gene Amplifications
- ClinicalTrials.gov ID
- NCT06299761
- Acronym / sponsor ID
- STARMAP / BBI-825-101
- Conditions
- Solid Tumor
- Keywords
- Amplification, Oncogene Amplification, ribonucleotide reductase inhibitor, RNR inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision made following an assessment of preliminary PK data from the Part 1 portion of the trial showing a lack of dose proportional exposure and the increasing complexity and associated development costs in this landscape.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Boundless Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 8 Mar 2024 (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.
BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies.
Detailed description
BBI-825 will be administered orally (PO) twice daily (BID) to subjects with 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- BBI-825 single agent dose escalation
| Arm | Type | Receives |
|---|---|---|
| Single Agent Dose Escalation | Experimental | Drug: BBI-825Single agent BBI-825, administered orally, twice daily, in 28-day cycles |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
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-825Also: ribonucleotide reductase inhibitorOral RNR inhibitor | Drug | Single Agent Dose Escalation |
Primary outcome
Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-825
Time frame: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)
TEAEs will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-825
Time frame: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)
The MTD and/or RP2D of BBI-825 will be determined.
5 secondary outcomes
Maximum observed plasma concentration (Cmax) of BBI-825
Time frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)
Trough observed plasma concentration (Ctrough) of BBI-825
Time frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)
Time to Cmax (Tmax) of BBI-825
Time frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)
Area under the concentration time curve (AUC) of BBI-825
Time frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)
Anti-tumor activity of BBI-825 as determined by RECISTv1.1
Time frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days)
Results and safety
The study was stopped early (reason given: Strategic decision made following an assessment of preliminary PK data from the Part 1 portion of the trial showing a lack of dose proportional exposure and the increasing complexity and associated development costs in this landscape.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 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 Doebele, MD study director
Boundless Bio, Inc.
5 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-825 in people with Solid Tumor, run by Boundless Bio, Inc. at 5 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 7 inclusion and 11 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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: Strategic decision made following an assessment of preliminary PK data from the Part 1 portion of the trial showing a lack of dose proportional exposure and the increasing complexity and associated development costs in this landscape.). 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?
Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-825 (time frame: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)). The study lists 2 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 8 Jun 2026.