Trial Summary
What is the purpose of this trial?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))
Eligibility Criteria
This trial is for adults with advanced adenoid cystic carcinoma (ACC) that's NOTCH active. They should have good organ function, no severe illnesses, and agree to use effective contraception. Treatment-naïve patients or those who've had certain therapies can join specific cohorts.Inclusion Criteria
I am fully active or restricted in physically strenuous activity but can do light work.
I agree to use birth control during the study.
I have another cancer that won't affect this treatment's safety or results.
+13 more
Exclusion Criteria
I currently have an active infection (bacterial, fungal, or viral).
I have finished radiotherapy and recovered from its immediate side effects.
The patient has a personal history of specific cardiovascular conditions
+8 more
Participant Groups
The study tests CB-103 alone or combined with Venetoclax in treating ACC by inhibiting the NOTCH pathway and blocking BCL-2 protein. Lenvatinib targets VEGFR pathways. The aim is to slow tumor growth and improve survival.
4Treatment groups
Experimental Treatment
Group I: Experimental: Cohort 2B- Lenvatinib + CB-103Experimental Treatment2 Interventions
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.
Group II: Experimental: Cohort 2A- Lenvatinib + CB-103Experimental Treatment2 Interventions
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.
Group III: Experimental: Cohort 1B - CB-103 + AbemaciclibExperimental Treatment2 Interventions
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.
Group IV: Experimental: Cohort 1A - CB-103 + AbemaciclibExperimental Treatment2 Interventions
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dana Farber Cancer InstituteBoston, MA
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Who Is Running the Clinical Trial?
Glenn J. HannaLead Sponsor
Cellestia Biotech AGIndustry Sponsor
Adenoid Cystic Carcinoma Research FoundationCollaborator