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Notch Inhibitor
AL101 for Triple Negative Breast Cancer (TENACITY 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 12 month
Awards & highlights
TENACITY Trial Summary
This trial will study whether the drug AL101 can treat people with a certain type of breast cancer that has spread or come back.
Eligible Conditions
- Breast Cancer
TENACITY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
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)
Duration of Response (DOR) by Investigator Review Based on RECIST v1.1
Side effects data
From 2022 Phase 2 trial • 87 Patients • NCT0369120779%
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
TENACITY Trial Design
1Treatment groups
Experimental Treatment
Group I: AL101Experimental Treatment1 Intervention
The study included a lead-in cohort with 6 subjects at 6mg AL101 weekly. 13 additional patients were treated with 4mg AL101 weekly.
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
325 Total Patients Enrolled
Andres Gutierrez, MD, PhDStudy DirectorExecutive Vice President & Chief Medical Officer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received palliative radiation therapy within the past week.You had a type of inflammation in your digestive system caused by previous immunotherapy treatment. It needs to be resolved to a mild level or lower, and you should not have needed steroid treatment for at least two weeks before starting the current treatment.You have moderate peripheral neuropathy (numbness or tingling in your hands or feet) for at least 14 days before starting the study treatment.You currently have or have had in the past 2 months a gastrointestinal condition that increases the risk of diarrhea, like inflammatory bowel disease or Crohn's disease.You have received treatment with gamma secretase inhibitors in the past.You have another type of cancer that is getting worse or needs treatment that might affect how we measure the results of this study. However, certain types of skin cancer or early-stage cervical cancer would not prevent you from participating.You have breast cancer that can potentially be cured with treatment, according to the doctor's opinion.You have visible signs of cancer spreading to your brain or spinal cord that are causing symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: AL101
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does AL101 treatment come with any safety risks that patients should be aware of?
"While there is some evidence that AL101 is safe for human consumption, its efficacy has yet to be proven in clinical trials. As such, it was given a 2."
Answered by AI
Where are patients able to enroll in this clinical trial?
"Patients can be enrolled at the University of Louisville- James Brown Cancer Center, Central Cancer Care, or University of California at San Francisco. There are 17 other potential sites for enrollment as well."
Answered by AI
Could you provide information about the current enrollment status of this trial?
"This specific trial, as noted on clinicaltrials.gov, is not currently looking for more participants-- the last update was March 31st, 2022. The study first appeared on August 14th 2020. However, there are 2439 other trials that are still recruiting patients."
Answered by AI
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