Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 6, 2026
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Phase 1/2 Trial.
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Registry record from ClinicalTrials.gov (NCT06814496). This is a study registration, not published results. Lead sponsor: University of Arizona. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: 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. Interventions: DRUG: Tarlatamab; RADIATION: Concurrent Radiation Therapy; RADIATION: Sequential Radiation therapy. Primary outcome measures: Percentage of participants experiencing dose limiting toxicities (DLT) attributed to radiation or combination of radiation and tarlatamab. , Until radiographic or disease progression or up to 24 months, whichever is earlier.. Brief summary: 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.