Description:
This is a Phase 2, non comparative, open label, multicenter study of AL101 in patients with recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations.
This is a Phase 2, non comparative, open label, multicenter study of AL101 in patients with recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations.
Active, not recruiting
Phase 2
Drug | Synonyms | Arms |
---|---|---|
AL101 | BMS 906024 | SINGLE-ARM |
Name | Type | Description | Interventions |
---|---|---|---|
SINGLE-ARM | Experimental | AL101 is an inhibitor of gamma secretase-mediated Notch signaling. |
|
Inclusion Criteria: 1. Confirmed Adenoid Cystic Carcinoma with known NOTCH 1/2/3/4 activating mutation that is recurrent or metastatic, not amenable to potentially curative surgery or radiotherapy. 2. Evidence of radiographic or clinical disease progression within 6-months of signing informed consent; newly diagnosed metastatic patients will be allowed. 3. Patients must have Formalin-fixed, Paraffin-embedded tissue available . 4. Must have at least 1 target lesion that is measurable for patients with nodal or visceral metastasis. Exclusion Criteria: 1. Diagnosed with a malignancy other than ACC in the past 2 years. 2. Uncontrolled, Active Infection 3. Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)] 4. Symptomatic central nervous system (CNS) metastases. 5. Unstable or severe uncontrolled medical condition 6. Eastern Cooperative Oncology Group (ECOG) performance status ≥2. 7. Abnormal organ and marrow function
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Objective response rate (ORR; complete response [CR] and partial response [PR]) by RECIST v1.1 |
Time Frame: | Up to 36 month |
Safety Issue: | |
Description: |
Measure: | Frequency, duration and severity of adverse events (AEs) and serious adverse events (SAEs); |
Time Frame: | Up to 36 month |
Safety Issue: | |
Description: |
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Ayala Pharmaceuticals, Inc, |
June 23, 2021