Study on Combining Radiation with Tarlatamab for DLL3 Expressing Tumors

Sponsor: University of Arizona

Sponsor score: 0

ClinicalTrials ID:NCT06814496

Provider View

This clinical trial is testing the safety of combining a new drug, tarlatamab, with radiation therapy for patients with tumors that express DLL3. The study aims to find out if this combination can be safely used in different parts of the body, including the brain.

Patient Parameters

Program Overview

This study is exploring whether adding a new drug called tarlatamab to radiation therapy can be safely used to treat tumors that express a protein called DLL3. The trial will first test this combination in patients with tumors outside the brain. If it is safe, the study will expand to include brain tumors. If the combination is not safe, the study will test giving the treatments one after the other, instead of at the same time. If that is also not safe, the study will continue with tarlatamab alone. A second part of the study will look at how well the treatment works in shrinking tumors that are not small cell lung cancer.

Description

This clinical trial is testing a new treatment approach for tumors that express a protein called DLL3. The study will first test the safety of combining a drug called tarlatamab with radiation therapy in patients with tumors outside the brain. If this is safe, the study will expand to include brain tumors. If not, the study will test giving the treatments one after the other. If that is also not safe, the study will continue with tarlatamab alone. The study will also look at how well the treatment works in shrinking tumors that are not small cell lung cancer. Up to 30 patients will participate, and they must be at least 18 years old and have tumors that express DLL3. The study will include patients with different types of tumors, such as melanoma, thyroid cancer, and bladder cancer, among others.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of certain types of tumors that express DLL3.
  • Have tried at least one other treatment that did not work.
  • Be willing to provide a sample of tumor tissue for testing.
  • Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 12 weeks.
  • Have measurable tumors that can be tracked using standard criteria.
  • Be eligible for radiation therapy to a tumor that has not been treated with radiation before.
  • Have adequate organ function as determined by specific blood tests.
  • Women of childbearing potential must agree to use effective contraception during the study and for 60 days after the last dose of tarlatamab.
  • Men must agree to use condoms or abstain from intercourse during the study and for 60 days after the last dose of tarlatamab.

Exclusion Criteria

  • Have tumors that cannot be treated with radiation therapy.
  • Have a history of lung disease or active lung inflammation.
  • Have had severe reactions to previous cancer treatments.
  • Have unresolved side effects from previous cancer treatments.
  • Have had a heart attack or heart failure within the past 12 months.
  • Have had a stroke or mini-stroke within the past 12 months.
  • Have an active infection that requires treatment.
  • Have a history of pituitary gland problems.
  • Have active hepatitis B or C infections.
  • Have had major surgery within the past 28 days.
  • Have an active autoimmune disease that requires treatment.
  • Have HIV infection unless it is well-controlled.
  • Have received tarlatamab or other cancer treatments within the past 30 days.
  • Have received a live vaccine within the past 28 days.
  • Women who are pregnant or breastfeeding.
  • Men who have a pregnant partner and are unwilling to use condoms.
  • Have known allergies to the study drugs.
  • Are unlikely to complete all study visits or procedures.

Locations

FACILITYZIPCITYSTATE
Arizona Cancer Center at UMC North/University Medical Center85719TucsonArizona

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