Phase 2 N=87 Treatment

A Study Of AL101In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

Adenoid Cystic Carcinoma

Bottom Line

View on ClinicalTrials.gov: NCT03691207 ↗

Enrolled (actual)

Serious AEs

56.3%

Results posted

Jan 2024

Primary outcome: Primary: Overall Response Rate (ORR) — 3; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AL101 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ayala Pharmaceuticals, Inc,
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Response Rate (ORR)	3; 2	—
SECONDARY Clinical Benefit Response Rate (CBR)	28; 24	—
SECONDARY Overall Survival	9.3; 9.4	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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.
Evidence of radiographic or clinical disease progression within 6-months of signing informed consent; newly diagnosed metastatic patients will be allowed.
Patients must have Formalin-fixed, Paraffin-embedded tissue available .
Must have at least 1 target lesion that is measurable for patients with nodal or visceral metastasis.

Exclusion Criteria

Diagnosed with a malignancy other than ACC in the past 2 years.
Uncontrolled, Active Infection
Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)]
Symptomatic central nervous system (CNS) metastases.
Unstable or severe uncontrolled medical condition
Eastern Cooperative Oncology Group (ECOG) performance status ≥2.
Abnormal organ and marrow function

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03691207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.