Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors
Eligible age
18–99 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: University of Arizona
You may qualify if…
- ✓ 1. Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
- ✓ 2. Subjects ≥ 18 years of age at the time of signing the informed consent.
- ✓ 3. Histologically or cytologically confirmed relapsed/refractory:
- ✓ 1. SCLC
- ✓ 2. Other tumors of small cell histology
- ✓ 3. High grade / poorly differentiated neuroendocrine histology tumor histologies with high prevalence of DLL3 (≥50% prevalence of ≥1% positivity), including but not limited to: melanoma, medullary thyroid cancer, esthesioneuroblastoma, bladder cancer, testicular cancer, glioblastoma multiforme, cervical cancer; large cell neuroendocrine tumor of lung, non-small cell lung cancers with mixed neuroendocrine features, and Merkel cell carcinoma OR
- ✓ 4. DLL3+ (≥1% by IHC) Note: If patients are DLL3 negative per IHC but have a DLL3 prevalant tumor type, they will be allowed to enroll on the study.
- ✓ 4. Subjects who progressed or recurred after at least one line of therapy and are considered treatment refractory per standard of care.
You may not qualify if…
- ✕ Re-irradiation, unless it is SRS/hfSRT after whole-brain radiation therapy (WBRT) or PCI or WBRT after SRS/hfSRT; re-irradiation of same lesion, unless verified with the Principal Investigator; patients with lesions not amenable to RT (including previously irradiated) will be only allowable on the tarlatamab monotherapy cohort.
- ✕ Disease Related
- ✕ 1. Subjects are excluded from the study if any of the following criteria apply:
- ✕ a. No lesion(s)/site(s) amenable to radiation therapy (only eligible for tarlatamab monotherapy if open) b. Planned re-irradiation of a previously irradiated site c. Leptomeningeal disease requiring craniospinal irradiation
- ✕ 2. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- ✕ 3. Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
- ✕ 4. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible (defined as having been present and stable for \> 21 days) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen.
- ✕ Other Medical Conditions
Where it's recruiting
Tucson
Seattle
Source: ClinicalTrials.gov · NCT06814496 · last updated 2026-07-20