Study of CB-103 with Lenvatinib or Abemaciclib for Advanced Adenoid Cystic Carcinoma
This study is for people with advanced adenoid cystic carcinoma (ACC) that has spread or come back, and has a specific change in the NOTCH signaling pathway. The goal is to see if combining CB-103 (a drug that targets the NOTCH pathway) with either Abemaciclib or Lenvatinib can slow tumor growth and help people live longer. You would receive one of two combinations: CB-103 plus Abemaciclib, or CB-103 plus Lenvatinib. Researchers will measure how long you live without your cancer getting worse (Progression-Free Survival) after 4 months to see if the treatments are successful. The study is currently recruiting about 32 participants.
- Study design
- This is a Phase 2, open-label study, meaning both you and your doctors will know which treatment you are receiving. It is not randomized, so you will be placed into one of two treatment groups. About 32 people are expected to participate.
- What's involved
- You would have screening for eligibility, treatment visits, imaging scans of your tumors, and blood tests. Participation is expected to last about 2 years, or until your disease gets worse, you can't tolerate the treatment, or you choose to stop.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures how long you live without your cancer getting worse at 4 months after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CB-103 With Either Lenvatinib or Abemaciclib in Patients With NOTCH ACC
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Glenn Hanna, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
Who to contact
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What this trial measures
- Progression-Free Survival (PFS) of Cohort 1At 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 2At 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.