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

Study acronym: RABBIT
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Minor Site details revised at 1 of 3 sites
  2. Minor Study sites: 2 to 3
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Study description expanded, about 4 words
  3. Minor Eligibility criteria expanded, about 22 wordsv9
  4. Minor Site details revised at 1 of 2 sitesv8
  5. Minor Study sites: 1 to 2v7
Show 5 earlier versionsHide 5 earlier versions
  1. Minor Start date changed from estimate of Sep 2025 to Sep 8, 2025
    • Site contact updated
    v6
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 2025 to Sep 2025
    • Site details revised
    v5
  3. Notable Start date: May 2025 to Aug 2025v4
  4. Minor Eligibility criteria shortened, about 35 words
    • Site contact updated
    v3
  5. Minor Eligibility criteria expanded, about 35 words
    • Site contact updated
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
4,790 trials monitored
See 263 trials at risk
and 6 more diseases
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.
Trial Details
NCT Number NCT06814496
Lead Sponsor University of Arizona
Collaborators: Amgen
Conditions
(from sponsor)
Melanoma, Medullary Thyroid Cancer, Sinonasal Undifferentiated Carcinoma, Esthesioneuroblastoma, Bladder Cancer, Testicular Cancer, Glioblastoma Multiforme, Cervical Cancer +3 more
Related terms Carcinoma, Medullary, Carcinoma, Merkel Cell, Carcinoma, Non-Small-Cell Lung, Esthesioneuroblastoma, Olfactory, Glioblastoma, Melanoma, Sinonasal undifferentiated carcinoma, Testicular Neoplasms, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov