Adenoid Cystic CarcinomaPhase 1/2NCT05774899
CB-103 With Either Lenvatinib or Abemaciclib in Patients With NOTCH ACC
A Phase 1/2 study testing CB-103, Abemaciclib and Lenvatinib in people with Adenoid Cystic Carcinoma and Metastatic Adenoid Cystic Carcinoma, run by Michael J. Dennis, MD at 1 site in United States.
Trial summary
The goal of this study is to treat patients with NOTCH active advanced adenoid cystic carcinoma (ACC) tumors with a combination or two different oral medications to slow tumor growth and improve survival outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoid Cystic Carcinoma, Metastatic Adenoid Cystic Carcinoma, Recurrent Adenoid Cystic Carcinoma
- What is being tested?
- CB-103, Abemaciclib and Lenvatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 1 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Participant has untreated or clinically symptomatic CNS metastases and/or carcinomatous meningitis
- The patient has had major surgery within 14 days prior to study registration.
- The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea).
- Impairment of GI function or presence of GI disease that may significantly alter the absorption of the study agents (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- The patient has active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
- The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
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- Pregnant or lactating women. Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued.
- Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and start of therapy. Patients on anticoagulants that require INR monitoring (such as warfarin). The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, or is currently enrolled in any other type of medical research judged by the sponsor not to be scientifically or medically compatible with this study.
- Corrected QTcF >450 msec for males and >470 msec for females in screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Michael Dennis, MD, 857-215-2840, michael_dennis@dfci.harvard.edu
Michael Dennis, 857-215-2840, michael_dennis@dfci.harvard.edu
About this study
Official title: A Phase 1/2 Study of CB-103 (Oral Pan-NOTCH Inhibitor) With Abemaciclib or Lenvatinib in Combination in Patients With NOTCH Activated Adenoid Cystic Carcinoma (CALCulus)
The goal of this study is to treat patients with NOTCH active advanced adenoid cystic carcinoma (ACC) tumors with a combination or two different oral medications to slow tumor growth and improve survival outcomes.
The names of the study drugs involved in this study are:
- CB-103 (an oral NOTCH pathway inhibitor)
- Abemaciclib (CDK4/6 inhibitor)
- Lenvatinib (a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI))
Read the detailed description
This is a phase 2, open-label, non-randomized, parallel cohort, multicenter study investigating the novel pan-NOTCH inhibitor, CB-103, in combination with the CDK4/6 inhibitor, Abemaciclib, and CB-103 in combination with the multi-targeted vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), Lenvatinib for patients with advanced, incurable, or metastatic adenoid cystic carcinoma (ACC) with a Notch pathway activating mutation.
Participants will be placed into one of two treatment groups: Cohort 1: CB-103 + Abemaciclib or Cohort 2: VEGFR TKI Lenvatinib + CB-103.
The U.S. Food and Drug Administration (FDA) has not approved CB-103 as a treatment for any disease.
The FDA has not approved Abemaciclib or Lenvatinib for advanced adenoid cystic carcinoma (ACC)), but it has been approved for other uses or cancer types.
Study procedures include screening for eligibility, treatment visits, radiologic scans of tumors, and blood tests.
Participation in this study is expected to last about 2 years or until disease progression, therapy intolerance, or participant withdrawal.
It is expected that about 32 people will take part in this research study.
Cellestia Biotech AG is supporting this research study by providing funding.
- Conditions
- Adenoid Cystic Carcinoma, Metastatic Adenoid Cystic Carcinoma, Recurrent Adenoid Cystic Carcinoma
- Being tested
- CB-103, Abemaciclib, Lenvatinib
- Keywords
- Adenoid Cystic Carcinoma, Metastatic Adenoid Cystic Carcinoma, Recurrent Adenoid Cystic Carcinoma, ACC
- Medical subject headings
- Carcinoma, Adenoid Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB-103Drug
First-in-class pan-NOTCH inhibitor, capsule taken orally.
AbemaciclibDrug
CDK4/6 inhibitor, tablet taken orally.
LenvatinibDrug
Also called Lenvima
Per standard care, capsule taken orally.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Cohort 1A - CB-103 + Abemaciclib | Experimental | A modified 3+3 dose escalation design will be used. 3-9 participants will receive:
* Standard of care Abemaciclib.
* Cycle 1 - End of Treatment
--Days 1- 28 of 28-day cycle: Predetermined dose of CB-103 2x daily on five consecutive days followed by two days of treatment break in each treatment week.
* A safety review will be performed by primary investigation after completion of the ramp-up phase. Receives: Drug: CB-103; Drug: Abemaciclib |
| Experimental: Cohort 1B - CB-103 + Abemaciclib | Experimental | Participants will receive:
* Cycle 1 - End of Treatment
--Days 1- 28 of 28-day cycle: Predetermined dose of CB-103 2x daily on five consecutive days followed by two days of treatment break in each treatment week and predetermined dose of Abemaciclib 1x daily.
* Therapy will continue until disease progression, therapy intolerance, or participant withdrawal.
* End of Treatment (EOT) visit within 30 days of last administration of study treatments. Receives: Drug: CB-103; Drug: Abemaciclib |
| Experimental: Cohort 2A- Lenvatinib + CB-103 | Experimental | A modified 3+3 dose escalation design will be used. 3-9 participants will receive:
* Standard of care VEGFR TKI.
* Cycle 1 - End of Treatment
--Days 1- 28 of 28-day cycle: Predetermined dose of CB-103 2x daily on five consecutive days followed by two days of treatment break in each treatment week.
* A safety review will be performed by primary investigation after completion of the ramp-up phase. Receives: Drug: CB-103; Drug: Lenvatinib |
| Experimental: Cohort 2B- Lenvatinib + CB-103 | Experimental | Participants will receive:
* Continue standard of care VEGFR TKI at prior dose and schedule.
* Cycle 1 - End of Treatment
--Day 1- 28 of 28-day cycle: Predetermined dose of CB-103 2x daily on five consecutive days followed by two days of treatment break in each treatment week.
* Therapy will continue until disease progression, therapy intolerance, or participant withdrawal.
* End of Treatment (EOT) visit within 30 days of last administration of study treatments. Receives: Drug: CB-103; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) of Cohort 1
Progression-Free Survival (PFS) is defined as the time from study registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Median PFS will be estimated via the Kaplan-Meier method to estimate all time-to-event endpoints with corresponding 95% confidence intervals (CI) for the median or time-specific event time
Measured: At 4 months
Progression-Free Survival (PFS) of Cohort 2
Progression-Free Survival (PFS) is defined as the time from study registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.
Measured: At 4 months
Secondary outcomes (4)
Number of Participants with treatment related Adverse Events per CTCAE 5.0
Assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Up to 2 years
Overall Response Rate (ORR)
Per RECIST v1.1
Measured: From enrollment to end of treatment up to 2 years
Overall Survival (OS)
Overall Survival (OS) is defined as the time from study registration to death due to any cause, or censored at date last known alive.
Measured: Up to 2 years
Duration of Overall Response (DOR)
The duration of overall response is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR), whichever is first recorded, until the first date that recurrent or progressive disease is objectively documented. Participants without events reported are censored at the last disease evaluation).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoid Cystic CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael J. Dennis, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Adenoid Cystic Carcinoma Research Foundation, Cellestia Biotech AG
- Responsible party
- Sponsor-investigator, Michael J. Dennis, MD, Dana-Farber Cancer Institute
- Investigators
- Michael Dennis, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774899
- Sponsor's protocol ID
- 23-011
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of CB-103 (Oral Pan-NOTCH Inhibitor) With Abemaciclib or Lenvatinib in Combination in Patients With NOTCH Activated Adenoid Cystic Carcinoma (CALCulus)
- ClinicalTrials.gov ID
- NCT05774899
- Acronym / sponsor ID
- 23-011
- Conditions
- Adenoid Cystic Carcinoma, Metastatic Adenoid Cystic Carcinoma, Recurrent Adenoid Cystic Carcinoma
- Keywords
- Adenoid Cystic Carcinoma, Metastatic Adenoid Cystic Carcinoma, Recurrent Adenoid Cystic Carcinoma, ACC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Michael J. Dennis, MDUniversity, hospital or other
- Collaborators
- Adenoid Cystic Carcinoma Research Foundation, Cellestia Biotech AG
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 20 Mar 2023 (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.
The goal of this study is to treat patients with NOTCH active advanced adenoid cystic carcinoma (ACC) tumors with a combination or two different oral medications to slow tumor growth and improve survival outcomes.
The names of the study drugs involved in this study are:
- CB-103 (an oral NOTCH pathway inhibitor)
- Abemaciclib (CDK4/6 inhibitor)
- Lenvatinib (a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI))
Detailed description
This is a phase 2, open-label, non-randomized, parallel cohort, multicenter study investigating the novel pan-NOTCH inhibitor, CB-103, in combination with the CDK4/6 inhibitor, Abemaciclib, and CB-103 in combination with the multi-targeted vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), Lenvatinib for patients with advanced, incurable, or metastatic adenoid cystic carcinoma (ACC) with a Notch pathway activating mutation.
Participants will be placed into one of two treatment groups: Cohort 1: CB-103 + Abemaciclib or Cohort 2: VEGFR TKI Lenvatinib + CB-103.
The U.S. Food and Drug Administration (FDA) has not approved CB-103 as a treatment for any disease.
The FDA has not approved Abemaciclib or Lenvatinib for advanced adenoid cystic carcinoma (ACC)), but it has been approved for other uses or cancer types.
Study procedures include screening for eligibility, treatment visits, radiologic scans of tumors, and blood tests.
Participation in this study is expected to last about 2 years or until disease progression, therapy intolerance, or participant withdrawal.
It is expected that about 32 people will take part in this research study.
Cellestia Biotech AG is supporting this research study by providing funding.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental: Cohort 1A - CB-103 + Abemaciclib | Experimental | Drug: CB-103, Drug: AbemaciclibA modified 3+3 dose escalation design will be used. 3-9 participants will receive: * Standard of care Abemaciclib. * Cycle 1 - End of Treatment --Days 1- 28 of 28-day cycle: Predetermined dose of CB-103 2x daily on five consecutive days followed by two days of treatment break in each treatment week. * A safety review will be performed by primary investigation after completion of the ramp-up phase. |
| Experimental: Cohort 1B - CB-103 + Abemaciclib | Experimental | Drug: CB-103, Drug: AbemaciclibParticipants will receive: * Cycle 1 - End of Treatment --Days 1- 28 of 28-day cycle: Predetermined dose of CB-103 2x daily on five consecutive days followed by two days of treatment break in each treatment week and predetermined dose of Abemaciclib 1x daily. * Therapy will continue until disease progression, therapy intolerance, or participant withdrawal. * End of Treatment (EOT) visit within 30 days of last administration of study treatments. |
| Experimental: Cohort 2A- Lenvatinib + CB-103 | Experimental | Drug: CB-103, Drug: LenvatinibA modified 3+3 dose escalation design will be used. 3-9 participants will receive: * Standard of care VEGFR TKI. * Cycle 1 - End of Treatment --Days 1- 28 of 28-day cycle: Predetermined dose of CB-103 2x daily on five consecutive days followed by two days of treatment break in each treatment week. * A safety review will be performed by primary investigation after completion of the ramp-up phase. |
| Experimental: Cohort 2B- Lenvatinib + CB-103 | Experimental | Drug: CB-103, Drug: LenvatinibParticipants will receive: * Continue standard of care VEGFR TKI at prior dose and schedule. * Cycle 1 - End of Treatment --Day 1- 28 of 28-day cycle: Predetermined dose of CB-103 2x daily on five consecutive days followed by two days of treatment break in each treatment week. * Therapy will continue until disease progression, therapy intolerance, or participant withdrawal. * End of Treatment (EOT) visit within 30 days of last administration of study treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Participant has untreated or clinically symptomatic CNS metastases and/or carcinomatous meningitis
- The patient has had major surgery within 14 days prior to study registration.
- The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea).
- Impairment of GI function or presence of GI disease that may significantly alter the absorption of the study agents (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- The patient has active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
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 |
|---|---|---|
| CB-103First-in-class pan-NOTCH inhibitor, capsule taken orally. | Drug | Experimental: Cohort 1A - CB-103 + Abemaciclib, Experimental: Cohort 1B - CB-103 + Abemaciclib, Experimental: Cohort 2A- Lenvatinib + CB-103, Experimental: Cohort 2B- Lenvatinib + CB-103 |
| AbemaciclibCDK4/6 inhibitor, tablet taken orally. | Drug | Experimental: Cohort 1A - CB-103 + Abemaciclib, Experimental: Cohort 1B - CB-103 + Abemaciclib |
| LenvatinibAlso: LenvimaPer standard care, capsule taken orally. | Drug | Experimental: Cohort 2A- Lenvatinib + CB-103, Experimental: Cohort 2B- Lenvatinib + CB-103 |
Primary outcome
Progression-Free Survival (PFS) of Cohort 1
Time frame: At 4 months
Progression-Free Survival (PFS) is defined as the time from study registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Median PFS will be estimated via the Kaplan-Meier method to estimate all time-to-event endpoints with corresponding 95% confidence intervals (CI) for the median or time-specific event time
Progression-Free Survival (PFS) of Cohort 2
Time frame: At 4 months
Progression-Free Survival (PFS) is defined as the time from study registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.
4 secondary outcomes
Number of Participants with treatment related Adverse Events per CTCAE 5.0
Time frame: Up to 2 years
Overall Response Rate (ORR)
Time frame: From enrollment to end of treatment up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Duration of Overall Response (DOR)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Michael Dennis, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CB-103, Abemaciclib and Lenvatinib in people with Adenoid Cystic Carcinoma and Metastatic Adenoid Cystic Carcinoma, run by Michael J. Dennis, MD at 1 site 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 0 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Dennis, MD (857-215-2840, michael_dennis@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) of Cohort 1 (time frame: At 4 months). 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 9 Sep 2026.