Phase 1 Study of Tarlatamab with Radiation for DLL3-Expressing Cancers
This study is testing the safety of combining a drug called tarlatamab with standard radiation therapy for people with certain cancers that have a specific marker called DLL3. These cancers include melanoma, medullary thyroid cancer, sinonasal undifferentiated carcinoma, esthesioneuroblastoma, and bladder cancer. Tarlatamab is a bispecific T-cell engager, meaning it helps your immune system fight cancer. The study will look at how many participants experience side effects (toxicities) from this combination. You can join if you are 18 years or older and have one of the listed relapsed or refractory cancers. The study aims to enroll 30 participants.
- Study design
- This is a Phase 1, open-label, single-arm study, meaning all participants receive the same treatment and both you and the study staff will know what treatment you are getting. It plans to enroll 30 participants.
- What's involved
- Tarlatamab will be given through an IV, starting with a lower dose and then increasing. Radiation therapy will be given either at the same time as tarlatamab or sequentially, with a break between treatments.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure side effects until your cancer grows or gets worse, or for up to 24 months, whichever comes first.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Charles Hsu, MD · PRINCIPAL_INVESTIGATOR · University of Arizona
- Ricklie Julian, MD · STUDY_CHAIR · University of Arizona
Who to contact
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What this trial 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.
The primary endpoint is safety, which will be measured by DLT using adverse events graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0) and ASTCT (CRS and ICANS). DLT will be defined as having 1) grade 3 - 5 non-hematologic adverse events (AEs) possibly, probably or definitely related to protocol treatment (radiation or combination of radiation and tarlatamab) by 8 weeks from start of radiation therapy; or 2) AEs possibly, probably, or definitely related to radiation or combination of radiation and tarlatamab leading to early termination of radiation or permanent discontinuation of tarlatamab. Grade 3+ AEs (or discontinuation) due to tarlatamab alone (not attributable to combination therapy) will not contribute to the primary endpoint. Frequency (%) of the patients with DLT will be reported by cohort.