Clinical trial · Interventional
A Study Of AL101In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
A Phase 2, Open-Label, Multi-center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
NCT03691207CI-TRIAL-00073466ACCURACYcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoid Cystic Carcinoma | Adenoid Cystic Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AL101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SINGLE-ARM
- description
- AL101 is an inhibitor of gamma secretase-mediated Notch signaling.
- interventionNames
- Drug: AL101
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 3 years and 7 months
- description
- ORR is defined as partial response (PR) + complete response (CR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for target lesions assessed by MRI. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Secondary outcomes (2)
- measure
- Clinical Benefit Response Rate (CBR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.