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A Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer

A Phase 2, Multi-center, Open-label, Single Arm Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer

NCT04461600•Ayala Pharmaceuticals, Inc,

View on ClinicalTrials.gov

Summary

The current study is designed to evaluate the efficacy and safety of AL101 monotherapy in subjects with Notch-activated recurrent or metastatic TNBC; Notch activation will be determined by a Next Generation Sequencing (NGS) test.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male of female subjects who are at least 18 years of age (inclusive) at the time of signing the Informed Consent Form (ICF).
•2. Have at least one measurable lesion per RECIST v1.1.
•3. Have formalin-fixed paraffin-embedded (FFPE) tissue available from a metastatic lesion; a tumor block or 25 unstained slides from an archived (within 2 years) or fresh tumor samples (core or punch needle biopsy) are acceptable.
•4. Documented tumor progression following no more than 3 lines of systemic chemotherapy, PARP inhibitor therapy or immunotherapy for metastatic disease, as appropriate. Of note, neoadjuvant and adjuvant therapy will not count as prior lines of therapy.
•5. Histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC defined as ER and progesterone receptor staining \<10%, and HER2 negative defined as IHC 0 to 1+
•6. Documented Notch activation from tumor biopsy results from within the last 2 years from a commercially available NGS assay, LDT or other validated IUO clinical trial assay.
•7. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test.

Exclusion Criteria

•1. A known additional malignancy that is progressing or requires active treatment that is considered medically active and may interfere in the ability to detect responses in this subject. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that have undergone potentially curative therapy or in situ cervical cancer.
•2. BC that, in the opinion of the investigator, is considered amenable to potentially curative treatment.
•3. Symptomatic central nervous system (CNS) metastases.
•4. Current or recent (within 2 months of IP administration) gastrointestinal (GI) disease or disorders that increase the risk of diarrhea, such as inflammatory bowel disease and Crohn's disease.
•5. Developed immune-mediated colitis with immunotherapy unless resolved to G1 or lower and without requirement of steroid treatment for at least 14 days prior to first dose of IP.
•6. Peripheral neuropathy Grade 2 for at least 14 days prior to first dose of IP.
•7. Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤7 days prior to administration of IP such as known active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
•8. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary function or uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the subject associated with his or her participation in the study.
•9. Eastern Cooperative Oncology Group (ECOG) performance status ≥2.
•10. Abnormal organ and marrow function defined as:
+15 more criteria

Locations (29)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Mayo Clinic

Phoenix, Arizona, United States

University of California at San Francisco

San Francisco, California, United States

University of Colorado

Aurora, Colorado, United States

Mayo Clinic

Jacksonville, Florida, United States

Comprehensive Hematology Oncology

St. Petersburg, Florida, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

The University of Chicago

Chicago, Illinois, United States

Carle Clinic

Urbana, Illinois, United States

University of Louisville- James Brown Cancer Center

Louisville, Kentucky, United States

Key Dates

Start Date

August 14, 2020

Primary Completion Date

March 23, 2022

Completion Date

October 11, 2022

Last Updated

February 12, 2024

Enrollment

ACTUAL participants

Conditions

Triple Negative Breast Cancer

Interventions

AL101

DRUG

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer

Inclusion Criteria

Exclusion Criteria

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