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Testing the drug tarlatamab with radiation in tumors that make DLL3

Official title: Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors

The short version

This trial is checking whether a drug called tarlatamab is safe to give along with radiation.

Read our full plain-language summary

What the trial team says

Phase I study to examine safety of the addition of concurrent tarlatamab with standard palliative and consolidative RT regimens , with a main cohort of N=20-24 patients with extracranial anatomic radiation sites. I) After lead in of 10 patients demonstrating safety of treatment, allow for expansion to cranial sites of disease (N=6-10) with continued enrollment in main cohort II) If toxicity criteria is not met in concurrent RT tarlatamab cohort, we will continue with sequential RT, either A) delivered within 7 days prior to cycle 1 day 1, or B) delivered during cycle 1 -2 but with pre- and post-RT washout of 7 days with no drug during RT, to examine safety in a temporally spaced setting. III) If sequential tarlatamab and radiation is not deemed safe, we would allow for continued enrollment to assess efficacy of drug sans radiation treatment, enriching for tumors not of small cell lung cancer histology and allowing for patients without sites amenable to RT. A nested phase II study will attempt to assess for ORR and safety of study intervention amongst tumors not of small cell lung cancer histology.

Key facts

Registry number

NCT06814496

Stage of testing

Phase 1/Phase 2

Conditions studied

Melanoma, Medullary Thyroid Cancer, Sinonasal Undifferentiated Carcinoma, Esthesioneuroblastoma, Bladder Cancer, Testicular Cancer, Glioblastoma Multiforme, Cervical Cancer, Large Cell Neuroendocrine Carcinoma of the Lung, Non Small Cell Lung Cancer, Merkel Cell Carcinoma

Where it is running

This trial lists 2 sites.

• Arizona
  • Arizona Cancer Center at UMC North/University Medical Center (Tucson)
• Washington
  • University of Washington Fred Hutchinson Cancer Center (Seattle)

This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.