Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

The study included a lead-in cohort with 6 subjects at 6mg AL101 weekly. 13 additional patients were treated with 4mg AL101 weekly.

AL101 is an inhibitor of gamma secretase-mediated Notch signaling.

AL101

Andres Gutierrez, MD, PhD

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.

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

ORR is defined as partial response (PR) + complete response (CR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for target lesions assessed by MRI.

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Clinical benefit response rate (CBR) is defined as complete response (CR) + partial response (PR) + stable disease (SD) by investigator review based on RECIST v1.1 for target lesions assessed by MRI.

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Stable Disease (SD): Neither sufficient shrinkage (at least 30%) to qualify for PR nor sufficient increase (more than 20%) to qualify for PD, taking as reference the smallest sum diameters.

Duration of response (DOR) is defined as the time from randomization to disease progression or death in patients who achieve complete or partial response.

Ayala Pharmaceuticals, Inc,

The analysis was done on the safety population which consists of 18 patients (6 patients in the 6mg arm, and 12 patients in the 4mg arm)

AL101 is an inhibitor of gamma secretase-mediated Notch signaling.

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AL101 6mg

AL101 4mg

AL101 is an inhibitor of gamma secretase-mediated Notch signaling. 4mg of AL101 was administered using an IV infusion pump over 60 minutes, once a week.

AL101 is an inhibitor of gamma secretase-mediated Notch signaling. 6mg of AL101 was administered using an IV infusion pump over 60 minutes, once a week.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

19 patients were enrolled, only 18 were treated.

Race (NIH/OMB)

Belgium

United States

Israel

Spain

Region of Enrollment

Chief Medical Officer

Overall Response Rate (ORR)

Clinical Benefit Response Rate (CBR)

Duration of response data was not collected as there were no patients with either CR or PR

Spots Global Cancer Trial Database for A Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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