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Notch Inhibitor

AL101 for Adenoid Cystic Carcinoma (ACCURACY Trial)

Phase 2
Waitlist Available
Research Sponsored by Ayala Pharmaceuticals, Inc,
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years and 7 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests AL101, an IV drug, in patients with recurrent or metastatic ACC who have specific genetic mutations. The drug aims to block proteins that help cancer cells grow.

Eligible Conditions
  • Adenoid Cystic Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years and 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years and 7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate (ORR)
Secondary study objectives
Clinical Benefit Response Rate (CBR)
Overall Survival

Side effects data

From 2022 Phase 2 trial • 87 Patients • NCT03691207
79%
Diarrhoea
60%
Fatigue
45%
Nausea
43%
Hypophosphataemia
38%
Cough
33%
Epistaxis
31%
Vomiting
31%
Dry mouth
29%
Decreased appetite
29%
Insomnia
26%
Weight decreased
24%
Constipation
21%
Dysgeusia
19%
Dyspnoea
19%
Rash
19%
Dermatitis acneiform
17%
Rash maculo-papular
17%
Alopecia
17%
Stomatitis
17%
Asthenia
17%
Dry skin
14%
Hypokalaemia
12%
Dysphonia
12%
Oropharyngeal pain
12%
Mucosal inflammation
12%
Hypocalcaemia
12%
Pruritus
10%
Dyspepsia
10%
Productive cough
10%
Oral pain
10%
Dehydration
10%
Hyperglycaemia
10%
Headache
10%
Dizziness
10%
Pneumonia
10%
Aspartate aminotransferase increased
10%
Alanine aminotransferase increased
10%
Platelet count decreased
10%
Back pain
10%
Dry eye
10%
Hypertension
10%
Anaemia
7%
Gastrooesophageal reflux disease
7%
Dysphagia
7%
Abdominal pain upper
7%
Hypoxia
7%
Pyrexia
7%
Oedema peripheral
7%
Facial pain
7%
Swelling face
7%
Palmar-plantar erythrodysaesthesia syndrome
7%
Erythema
7%
Night sweats
7%
Neuralgia
7%
Urinary tract infection
7%
Oral candidiasis
7%
Candida infection
7%
Neutrophil count increased
7%
Arthralgia
7%
Vision blurred
7%
Infusion related reaction
5%
Pneumonia aspiration
5%
Cardiac arrest
5%
Nasal dryness
5%
Skin lesion
5%
Anxiety
5%
Depression
2%
Sepsis
2%
Clostridium difficile colitis
2%
Abdominal infection
2%
Anorectal infection
2%
Campylobacter sepsis
2%
Cellulitis
2%
Pneumonia pseudomonal
2%
Streptococcal bacteraemia
2%
Respiratory failure
2%
Acute respiratory distress syndrome
2%
Bronchial obstruction
2%
Eosinophilic pneumonia
2%
Haemoptysis
2%
Pleural effusion
2%
Pneumonitis
2%
Brain cancer metastatic
2%
Brain neoplasm
2%
Metastases to central nervous system
2%
Squamous cell carcinoma
2%
Encephalopathy
2%
Femoral neck fracture
2%
Ejection fraction decreased
2%
Drug-induced liver injury
2%
Hepatobiliary disease
2%
Pathological fracture
2%
Vasculitis
2%
Abdominal pain
2%
Nasal congestion
2%
Upper-airway cough syndrome
2%
Chills
2%
Hyponatraemia
2%
Musculoskeletal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2 - AL101 6mg
Cohort 1 - AL101 4mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SINGLE-ARMExperimental Treatment1 Intervention
AL101 is an inhibitor of gamma secretase-mediated Notch signaling.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AL101
2018
Completed Phase 2
~180

Find a Location

Who is running the clinical trial?

Ayala Pharmaceuticals, Inc,Lead Sponsor
3 Previous Clinical Trials
256 Total Patients Enrolled
~13 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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