CB-103 With Either Lenvatinib or Abemaciclib in Patients With NOTCH ACC

Recruiting now · Phase 1/Phase 2

Conditions studied: Adenoid Cystic Carcinoma, Metastatic Adenoid Cystic Carcinoma, Recurrent Adenoid Cystic Carcinoma

In brief

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))

Key facts

Study ID

NCT05774899

Run by

Glenn J. Hanna

People needed

32

Starts

2023-06-01

Expected to finish

2028-06-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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
• 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

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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