Active — Not RecruitingPhase 2/3

A Study of AL102 in Patients With Progressing Desmoid Tumors

United States198 participantsStarted 2021-03-30

Plain-language summary

The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors.

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. At least 18 years of age (inclusive) at the time of signing the informed consent form (ICF).
✓. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist (prior to informed consent).
✓. Disease progression, assessed locally by the investigator, defined as having at least one of the following:
✓. At least 1 measurable lesion amenable to volume measurements by MRI at screening (Part A only)
✓. One of the following:
✓. Agrees to provide formalin-fixed paraffin embedded archival or fresh tumor tissue for re- confirmation of disease.
✓. Must be able to swallow whole capsules with no GI condition affecting absorption; nasogastric or G-tube administration is not allowed.

✕. Diagnosed with a malignancy in the past 2 years with some exceptions.
✕. Current or recent (within 2 months of IP administration) GI disease or disorders that increase the risk of diarrhea, such as inflammatory bowel disease and Crohn's disease.
✕. 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) at Screening.
✕. Myocardial infarction within 6 months prior to enrollment, greater than Class 1 angina pectoris, or has New York Heart Association (NYHA) Class III or IV heart failure, , symptomatic ventricular arrhythmias, sustained ventricular tachycardia, Torsade's de Pointes (TdP), the long QT syndrome, pacemaker dependence, or electrocardiographic evidence of acute ischemia.
✕. 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.
✕. Pregnant or breastfeeding or expecting to conceive children within the projected duration of the study.
✕. Eastern Cooperative Oncology Group (ECOG) performance status ≥2
✕. Abnormal organ and marrow function at Screening defined as:

Progression free survival

Timeframe: Approximately 2 years

NCT IDNCT04871282

SponsorImmunome, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-03

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. At least 18 years of age (inclusive) at the time of signing the informed consent form (ICF).
✓. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist (prior to informed consent).
✓. Disease progression, assessed locally by the investigator, defined as having at least one of the following:
✓. At least 1 measurable lesion amenable to volume measurements by MRI at screening (Part A only)
✓. One of the following:
✓. Agrees to provide formalin-fixed paraffin embedded archival or fresh tumor tissue for re- confirmation of disease.
✓. Must be able to swallow whole capsules with no GI condition affecting absorption; nasogastric or G-tube administration is not allowed.

✕. Diagnosed with a malignancy in the past 2 years with some exceptions.
✕. Current or recent (within 2 months of IP administration) GI disease or disorders that increase the risk of diarrhea, such as inflammatory bowel disease and Crohn's disease.
✕. 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) at Screening.
✕. Myocardial infarction within 6 months prior to enrollment, greater than Class 1 angina pectoris, or has New York Heart Association (NYHA) Class III or IV heart failure, , symptomatic ventricular arrhythmias, sustained ventricular tachycardia, Torsade's de Pointes (TdP), the long QT syndrome, pacemaker dependence, or electrocardiographic evidence of acute ischemia.
✕. 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.
✕. Pregnant or breastfeeding or expecting to conceive children within the projected duration of the study.
✕. Eastern Cooperative Oncology Group (ECOG) performance status ≥2
✕. Abnormal organ and marrow function at Screening defined as: