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ACTIVE_NOT_RECRUITINGPHASE2/PHASE3

A Study of AL102 in Patients With Progressing Desmoid Tumors

RINGSIDE: A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients With Progressing Desmoid Tumors

NCT04871282•Immunome, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

This is a Phase 2/3, randomized study in subjects with progressive desmoid tumors consisting of 2 parts. Phase2/Part A is an open-label, dose regimen finding study; Phase3/Part B is a double blind, placebo-controlled study and Open Label Extension utilizing the dose regimen selected in Phase2/Part A.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. At least 18 years of age (inclusive) at the time of signing the informed consent form (ICF).
•2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist (prior to informed consent).
•3. Disease progression, assessed locally by the investigator, defined as having at least one of the following:
•* Unidimensional growth of desmoid tumor(s) by ≥10%, using the sum of the largest diameters of target lesion(s), within 18 months of the screening MRI
•* Having desmoid tumor-related pain that is not adequately controlled with nonopioid medication
•4. At least 1 measurable lesion amenable to volume measurements by MRI at screening (Part A only)
•5. One of the following:
•* Treatment naïve subjects for whom, in the opinion of the investigator, the IP is deemed appropriate, OR
•* Recurrent/refractory disease following at least one line of therapy (including surgery, radiation, or systemic therapy)
•6. Agrees to provide formalin-fixed paraffin embedded archival or fresh tumor tissue for re- confirmation of disease.
+6 more criteria

Exclusion Criteria

•1. Diagnosed with a malignancy in the past 2 years with some exceptions.
•2. 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.
•3. 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.
•4. 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.
•5. 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.
•6. Pregnant or breastfeeding or expecting to conceive children within the projected duration of the study.
•7. Eastern Cooperative Oncology Group (ECOG) performance status ≥2
•8. Abnormal organ and marrow function at Screening defined as:
•1. Neutrophils \<1000/mm3,
•2. Platelet count \<100,000/mm3,
+14 more criteria

Locations (53)

Mayo Clinic

Pheonix, Arizona, United States

City of Hope

Duarte, California, United States

Sarcoma Oncology Research Center

Santa Monica, California, United States

University of California at Los Angeles Hematology/Oncology

Santa Monica, California, United States

Stanford University Medical Center

Stanford, California, United States

Mayo Clinic

Jacksonville, Florida, United States

NorthShore University Health System

Evanston, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Jefferson City Medical Group

Jefferson City, Missouri, United States

Key Dates

Start Date

March 30, 2021

Primary Completion Date

December 3, 2025

Completion Date

October 1, 2026

Last Updated

February 5, 2026

Enrollment

198

ACTUAL participants

Conditions

DesmoidDesmoid Tumor

Interventions

AL102

DRUG

Placebo

OTHER

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RECRUITINGNA

Cryotherapy in the Treatment of Desmoid Tumors

NCT05091255

Desmoid

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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 5, 2026Data 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 AL102 in Patients With Progressing Desmoid Tumors

Inclusion Criteria

Exclusion Criteria

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