RecruitingPhase 2NCT04673942

A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors

An Adapted Phase 2a/2b, Study to Evaluate the Safety, Tolerability, and Efficacy of AdAPT-001 in Subjects With Refractory Solid Tumors


Sponsor

EpicentRx, Inc.

Enrollment

140 participants

Start Date

Mar 29, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

AdAPT-001 is an oncolytic virus that is injected directly into the tumor or via intraarterial administration. The purpose of this study is to find out if AdAPT-001 is safe and tolerable. The next step is to find out if AdAPT-001 if efficacious with or without a checkpoint inhibitor.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer treatment called AdAPT-001, which is a modified virus designed to selectively infect and destroy cancer cells while also stimulating the immune system to fight the tumor. It is being tested in patients with sarcoma (a cancer of the connective tissue) and other solid tumors that have stopped responding to conventional treatments. **You may be eligible if you:** - Are 18 years of age or older - Have a confirmed advanced solid tumor that has progressed through all standard treatments - Have a tumor that is accessible for direct injection (either by feeling it or with ultrasound guidance) - Are in good health (ECOG performance status 0–1) - Have acceptable liver, kidney, and blood function **You may NOT be eligible if you:** - Have not yet tried standard therapies for your cancer type - Have active brain metastases - Have severe immune deficiency or are on immunosuppressive treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAdAPT-001

Oncolytic virus administered by intratumoral injection

DRUGCheckpoint Inhibitor, Immune

Checkpoint Inhibitor per investigator discretion based on diagnosis and subject tolerability


Locations(6)

City of Hope

Duarte, California, United States

California Cancer Associates for Research and Excellence, cCARE

San Marcos, California, United States

Providence Saint John's Health Center

Santa Monica, California, United States

Cleveland Clinic

Cleveland, Ohio, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04673942


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