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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

ACCURACY Trial Summary

This trial will test a new drug, AL101, on patients with a certain type of cancer that has spread or returned. The patients have mutations in the NOTCH 1,2,3,4 genes, which the drug may be able to treat.

Eligible Conditions
  • Adenoid Cystic Carcinoma

ACCURACY Trial 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

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

ACCURACY 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
USC Norris Comprehensive Cancer center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study Of AL101In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
2018. "A Study Of AL101In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03691207.
~14 spots leftby Apr 2025
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