Study: TK216 for Treatment of Ewing Sarcoma


Oncternal Therapeutics is working on TK216, a drug that is the first in its class to treat Ewing sarcoma. They have recently opened enrollment for Phase 1b of their clinical trial after favorable results came from the dose-finding phase. This expansion of the first phase will better prepare researchers and participants for the second phase of the trial, as it plans to investigate the recommended dosage for the next step. Oncternal Therapeutics is excited for the results of this next phase and for the overall findings of the study. They hope that TK216 will become a new type of drug used to treat Ewing sarcoma and that it will better the lives of patients.

About Ewing Sarcoma

Ewing sarcoma is a rare form of cancer that begins in the bones or the soft tissue surrounding them. This cancer can take place in any bone, but most commonly starts in the long bones of the pelvis, legs, and arms. At times it can also begin in the soft tissue of the arms, legs, abdomen, or other parts of the body. While it is most likely to affect teenagers and young adults, Ewing sarcoma can affect people of any age.

The cause of this cancer is unknown. There are cells that have been found to be linked to Ewing sarcoma, but it is not thought to be an inherited disease. Healthcare professionals are also unsure of the risk factors that may be associated with this cancer.

Symptoms of Ewing sarcoma are pain, swelling, tenderness, bone pain that can worsen with physical activity or at night, unexplained fatigue, fever, unintentional weight loss, or broken bones without a known cause. There are also complications associated with Ewing sarcoma. This cancer can spread to other parts of the body, which makes treatment and recovery more difficult. It can also return after treatment.

It is typically noticed when people are brought in for sprains or other injuries, and x-rays reveal that there is something more behind the pain. Further imaging tests are usually necessary. CT scans, MRIs, PET scans, and bone scans may all be ordered. Biopsies are ordered after these tests, either needle or surgical biopsies.

Treatment for Ewing sarcoma includes chemotherapy, radiation, surgery, or clinical trials. There have been many advances in the treatment of this disease over the years, so outlooks for patients are much better than they once were.

About TK216

TK216 is an investigational drug that is meant to inhibit the E26 transformation-specific (ETS) family of oncoproteins. It blocks the interaction of these proteins and others, which leads to tumor cell apoptosis and stops the tumor from growing further. It has been granted the orphan drug designation and fast track designation from the FDA. While it has not yet been approved for any indication, if it is approved it will be the first in its class.

About the Study

TK216 is currently in the first phase of evaluation. Participants have relapsed or refractory Ewing sarcoma and are being enrolled in seven clinical trial centers across the United States. It is a single agent trial, and the drug is being studied in combination with vincristine. Phase 1 was meant to find the correct dosage of TK216, and Phase 1b is evaluating the dosage that will be used in Phase 2.

Researchers are hopeful that there will be favorable outcomes of this study, as this drug has the potential to treat other cancers that are associated with the ETS family of proteins as well as Ewing sarcoma. Oncternal Therapeutics focuses on treatments for cancers that have an “unmet medical need,” and it hopes that TK216 will be able to treat more than one form of these cancers.

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